A Randomized, Double-blind, Placebo-controlled Phase 1b/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Repeated Subcutaneous Administration of SON-080 in Patients With Persistent Chemotherapy-induced Peripheral Neuropathy (CIPN) After the End of Chemotherapeutic Treatment

The study will be conducted in adult patients with Chemotherapy-induced Peripheral Neuropathy (CIPN) that has been persistent for at least 3 months following completion of chemotherapy. A total of 60 patients will be enrolled in equal numbers of a placebo group and two different SON-080 dose groups. Treatment period will be 12 weeks long and patients will be followed-up for an additional 12 weeks.

开始日期2022-10-27

申办/合作机构

Sonnet BioTherapeutics, Inc.

100 项与 Atexakin alfa 相关的临床结果

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100 项与 Atexakin alfa 相关的转化医学

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100 项与 Atexakin alfa 相关的专利（医药）

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项与 Atexakin alfa 相关的文献（医药）

2024-03-01·Brain research bulletin

Valproate attenuates somatic hyperalgesia induced by orofacial inflammation combined with stress through inhibiting spinal IL-6 and STAT1 phosphorylation

Article

作者: Traub, Richard J ; Qiu, Xin-Yi ; Xu, Tian-Ming ; Cao, Dong-Yuan ; Xu, Chen-Xi ; Guo, Yi ; Feng, Hai-Nan

Temporomandibular disorder (TMD) and fibromyalgia syndrome (FMS) may present as comorbid conditions, but treatment options are ineffective. The purpose of this study was to investigate whether valproate (VPA) attenuates somatic hyperalgesia induced by orofacial inflammation combined with stress, which represents a model of pain associated with TMD and FMS comorbidity, and to explore the potential mechanisms. The results showed that VPA inhibited somatic hyperalgesia induced by orofacial inflammation combined with stress, and down-regulated the interleukin-6 (IL-6) expression in the L4-L5 spinal dorsal horn of female rats. The anti-nociceptive effect of VPA was blocked by single or 5 consecutive day intrathecal administration of recombinant rat IL-6. Orofacial inflammation combined with stress up-regulated the ratio of phosphorylated signal transducer and activator of transcription 1 (p-STAT1) to STAT1 (p-STAT1/STAT1) in the spinal cord. VPA did not affect the STAT1 expression, while it down-regulated the ratio of p-STAT1/STAT1. The expression of STAT3 and the ratio of p-STAT3/STAT3 were not affected by orofacial inflammation combined with stress and VPA treatment. Intrathecal administration of exogenous IL-6 up-regulated the ratio of p-STAT1/STAT1. These data indicate that VPA attenuated somatic hyperalgesia induced by orofacial inflammation combined with stress via inhibiting spinal IL-6 in female rats, and the mechanism may involve the alteration of activation status of spinal STAT1. Thus, VPA may be a new candidate analgesic that targets IL-6 and STAT1 for the treatment of pain associated with the comorbidity of TMD and FMS.

2024-01-01·Naunyn-Schmiedeberg's archives of pharmacology

Isoliquiritigenin attenuates high glucose-induced proliferation, inflammation, and extracellular matrix deposition in glomerular mesangial cells by suppressing JAK2/STAT3 pathway

Article

作者: Zhang, Ziyuan ; Shi, Qiwen ; Deng, Shufen

To investigate the effect of isoliquiritigenin (ISL) on high glucose (HG)-induced glomerular mesangial cells (GMCs) proliferation, extracellular matrix (ECM) deposition and inflammation, and the underlying mechanisms. Mouse GMCs (SV40-MES-13) were cultured in HG medium, with or without ISL. The proliferation of GMCs was determined by MTT assay. The production of proinflammatory cytokines was detected by qRT-PCR and ELISA. The expression of connective tissue growth factor (CTGF), TGF-β1, collagen IV, and fibronectin was measured by qRT-PCR and western blot. The phosphorylation of JAK2 and STAT3 was examined by western blot. Next, JAK2 inhibitor AG490 was applied to HG-exposed GMCs. The levels of JAK2/STAT3 phosphorylation and pro-fibrotic markers were analyzed by western blot, and the secretion of TNF-α and IL-1β was evaluated by ELISA. GMCs were treated with HG, HG plus ISL or HG plus ISL, and recombinant IL-6 (rIL-6) which is a JAK2 activator. The levels of JAK2/STAT3 activation, ECM formation, and proinflammatory cytokines secretion were determined by western blot and ELISA, respectively. In mouse GMCs, ISL successfully repressed HG-induced hyperproliferation; production of TNF-α and IL-1β; expression of CTGF, TGF-β1, collagen IV, and fibronectin; and activation of JAK2/STAT3. Similar to ISL, AG490 was able to reverse the inflammation and ECM generation caused by HG. Moreover, rIL-6 impeded the amelioration of ISL on HG-induced adverse effects. Our study demonstrated that ISL displayed preventive effects on HG-exposed GMCs through inhibiting JAK2/STAT3 pathway and provided an insight into the application of ISL for diabetic nephropathy (DN) treatment.

2022-04-01·Journal of cachexia, sarcopenia and muscle1区 · 医学

Interleukin‐6 potentiates endurance training adaptation and improves functional capacity in old mice

1区 · 医学

ArticleOA

作者: Sagot, Yves ; Schneider‐Heieck, Konstantin ; Leuchtmann, Aurel B. ; Handschin, Christoph ; Steurer, Stefan A. ; Karrer‐Cardel, Bettina ; Furrer, Regula

Abstract:

Background:

Interventions to preserve functional capacities at advanced age are becoming increasingly important. So far, exercise provides the only means to counteract age‐related decrements in physical performance and muscle function. Unfortunately, the effectiveness of exercise interventions in elderly populations is hampered by reduced acceptance and compliance as well as disuse complications. We therefore studied whether application of interleukin‐6 (IL‐6), a pleiotropic myokine that is induced by skeletal muscle activity and exerts broad systemic effects in response to exercise, affects physical performance and muscle function alone or in combination with training in aged mice.

Methods:

Sedentary old male mice (Sed+Saline, n = 15) were compared with animals that received recombinant IL‐6 (rIL‐6) in an exercise‐mimicking pulsatile manner (Sed+IL‐6, n = 16), were trained with a moderate‐intensity, low‐volume endurance exercise regimen (Ex+Saline, n = 13), or were exposed to a combination of these two interventions (Ex+IL‐6, n = 16) for 12 weeks. Before and at the end of the intervention, mice underwent a battery of tests to quantify endurance performance, muscle contractility in situ, motor coordination, and gait and metabolic parameters.

Results:

Mice exposed to enhanced levels of IL‐6 during endurance exercise bouts showed superior improvements in endurance performance (33% more work and 12% greater peak power compared with baseline), fatigue resistance in situ (P = 0.0014 vs. Sed+Saline; P = 0.0199 vs. Sed+IL‐6; and P = 0.0342 vs. Ex+Saline), motor coordination (rotarod performance, P = 0.0428), and gait (gait speed, P = 0.0053) following training. Pulsatile rIL‐6 treatment in sedentary mice had only marginal effects on glucose tolerance and some gait parameters. No increase in adverse events or mortality related to rIL‐6 treatment was observed.

Conclusions:

Administration of rIL‐6 paired with treadmill running bouts potentiates the adaptive response to a moderate‐intensity low‐volume endurance exercise regimen in old mice, while being safe and well tolerated.

项与 Atexakin alfa 相关的新闻（医药）

2024-05-14

·BioSpace

Sonnet BioTherapeutics Provides Fiscal Year 2024 Second Quarter and Year-to-Date Business and Earnings Update

Published Phase 1 data of SON-1010 in Frontiers in Immunology demonstrating the safety and tolerability of the F H AB-derived Interleukin 12 in healthy volunteers Announced early safety data from the company's Phase 1b/2a clinical trial of SON-080 in patients with chemotherapy-induced peripheral neuropathy (CIPN) Received $4.3 million in net proceeds from the sale of net operating losses through the New Jersey Technology Business Tax Certificate Transfer Program Presented preclinical data and information on the clinical trial design from the study of SON-080 in CIPN in a poster session at the American Association for Cancer Research (AACR) Annual Meeting PRINCETON, NJ / ACCESSWIRE / May 14, 2024 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, announced today its financial results for the three months and six months ended March 31, 2024 and provided a business update. "We are very excited about the progress we made during the first calendar quarter of this year with the SON-1010 and SON-080 programs, where the foundations for the compounds' safety profiles were further strengthened. We will look to continue to build on the supporting data for SON-1010 with the forthcoming look at the PDL-1 combination study in platinum-resistant ovarian cancer during the current quarter" said Pankaj Mohan, Ph.D., Sonnet Founder and Chief Executive Officer. FY 2024 Second Quarter and Recent Corporate Updates Sonnet provided the following corporate updates: On February 29, 2024, announced a publication demonstrating the safety and tolerability of SON-1010 in healthy volunteers in Frontiers in Immunology . The paper, entitled "A phase I trial of SON-1010, a tumor-targeted, Interleukin 12-linked, albumin-binding cytokine, shows favorable pharmacokinetics, pharmacodynamics, and safety in healthy volunteers". SON-1010 was shown to be safe and well-tolerated up to 300 ng/kg as a single ascending dose in healthy volunteers int the study called SB102 ( NCT05408572 ). The pharmacokinetic (PK) comparison with cancer patients suggests the drug is targeting and being retained in the tumor microenvironment (TME), as was shown in mouse models of biodistribution. The study was first announced in July 2022 and was done in parallel with the ongoing SB101 study in cancer patients ( NCT05352750 ). The results from SB102 provide the initial ‘desensitizing dose' of 300 ng/kg for further dose escalation of the maintenance dose in SB101, to establish the maximum tolerated dose for this molecule. In the B16F10 melanoma model, a single dose of SON-1010 resulted in a marked reduction of tumor growth that was concomitant with increased IFNγ, along with augmenting immune cell numbers and activity in the TME. On March 11, 2024, announced early safety data from the company's Phase 1b/2a clinical trial of SON-080 in patients with CIPN, which met the study's initial pre-specified objective. Based on this data, SON-080 was cleared to proceed after review by the independent Data Safety Monitoring Board (DSMB). The study (SB211, NCT05435742 ) was being conducted at two sites in Australia in patients with persistent CIPN using a new proprietary version of recombinant human Interleukin 6 (rhIL-6), which required confirmation of safety before moving forward with further enrollment. CIPN development has been placed on hold and the data will be leveraged to initiate a new Phase 2 study in the larger Diabetic Peripheral Neuropathy (DPN) indication. Sonnet has initiated partnering outreach with the intention of further moving the asset forwards towards commercialization. On April 10, 2024, presented preclinical data and information on the clinical trial design from the study of SON-080 in CIPN in a poster session at the American Association for Cancer Research (AACR) Annual Meeting. The poster titled, "Low Dose Interleukin 6 (SON-080) for Neuropathies: Toxicology and Clinical Plans" can be accessed here via the company's website. FY 2024 Second Quarter Ended March 31, 2024 Financial Results As of March 31, 2024, Sonnet had $3.8 million cash on hand and no debt. Research and development expenses were $2.2 million for the three months ended March 31, 2024, compared to $3.8 million for the three months ended March 31, 2023. The decrease of $1.6 million was primarily due to cost saving initiatives, as we are managing expenses for liquidity purposes and are tightening our focus on the research and development projects we have assessed to have the greatest near-term potential. In addition to transitioning product development activities to cost advantaged locations such as India and Australia, we have reduced expenditures on tertiary programs and suspended antiviral development related to SON-1010, as well as programs related to SON-080 and SON-1210 while we seek partnering opportunities. General and administrative expenses were $1.7 million for the three months ended March 31, 2024, compared to $1.9 million for the three months ended March 31, 2023. The decrease of $0.2 million relates primarily to cost saving initiatives, as we are managing expenses for liquidity purposes, and a decrease in consulting expenses related to licensing, partially offset by an increase in legal and professional expenses. "We ended another quarter with solid pipeline progress and continue to work to manage our operating expense infrastructure accordingly. Furthermore, we are pleased that during the quarter, Sonnet could leverage the New Jersey Technology Business Tax Certificate Transfer Program to generate $4.3 million in net proceeds from the sale of our net operating losses. Consistent with our previous guidance, we project that our existing cash on hand will sustain the Company into July 2024, with the potential for additional expense reductions to take us into August. We recently entered into an equity facility with Chardan to raise additional capital" said Jay Cross, CFO. About Sonnet BioTherapeutics Holdings, Inc. Sonnet BioTherapeutics is an oncology-focused biotechnology company with a proprietary platform for innovating biologic drugs of single or bifunctional action. Known as F H AB (Fully Human Albumin Binding), the technology utilizes a fully human single chain antibody fragment (scFv) that binds to and "hitch-hikes" on human serum albumin (HSA) for transport to target tissues. Sonnet's F H AB was designed to specifically target tumor and lymphatic tissue, with an improved therapeutic window for optimizing the safety and efficacy of immune modulating biologic drugs. F H AB is the foundation of a modular, plug-and-play construct for potentiating a range of large molecule therapeutic classes, including cytokines, peptides, antibodies, and vaccines. Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's cash runway, the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Sonnet BioTherapeutics Investor Contact: Jack Yauch Solebury Strategic Communications 862-754-1024 jyauch@soleburystrat.com Sonnet BioTherapeutics Holdings, Inc. Consolidated Balance Sheets (unaudited) March 31, 2024 September 30, 2023 Assets Current assets: Cash $ 3,786,184 $ 2,274,259 Prepaid expenses and other current assets 1,058,836 1,677,396 Incentive tax receivable 377,962 786,574 Total current assets 5,222,982 4,738,229 Property and equipment, net 26,944 33,366 Operating lease right-of-use asset 159,641 193,689 Deferred offering costs 15,000 49,988 Other assets 484,842 414,206 Total assets $ 5,909,409 $ 5,429,478 Liabilities and stockholders' equity (deficit) Current liabilities: Accounts payable $ 1,752,444 $ 2,201,999 Accrued expenses and other current liabilities 933,747 3,230,922 Current portion of operating lease liability 78,493 73,048 Deferred income - 18,626 Total current liabilities 2,764,684 5,524,595 Operating lease liability, net of current portion 90,446 130,863 Total liabilities 2,855,130 5,655,458 Commitments and contingencies (Note 4) Stockholders' equity (deficit): Common stock, $0.0001 par value: 125,000,000 shares authorized; 3,112,401 and 1,750,426 issued and outstanding at March 31, 2024 and September 30, 2023, respectively 311 175 Additional paid-in capital 114,100,805 110,017,598 Accumulated deficit (111,046,837 ) (110,243,753 ) Total stockholders' equity (deficit) 3,054,279 (225,980 ) Total liabilities and stockholders' equity (deficit) $ 5,909,409 $ 5,429,478 Sonnet BioTherapeutics Holdings, Inc. Consolidated Statements of Operations (unaudited) Three Months Ended March 31, Six Months Ended March 31, 2024 2023 2024 2023 Collaboration revenue $ - $ 36,445 $ 18,626 $ 73,700 Operating expenses: Research and development 2,167,288 3,816,644 2,811,330 7,562,584 General and administrative 1,701,273 1,884,569 2,354,728 3,788,278 Total operating expenses 3,868,561 5,701,213 5,166,058 11,350,862 Loss from operations (3,868,561 ) (5,664,768 ) (5,147,432 ) (11,277,162 ) Other income 4,327,946 - 4,327,946 - Foreign exchange (loss) gain (93,960 ) (2,303 ) 16,402 67,949 Net income (loss) $ 365,425 $ (5,667,071 ) $ (803,084 ) $ (11,209,213 ) Per share information: Net income (loss) per share, basic $ 0.08 $ (7.55 ) $ (0.19 ) $ (21.14 ) Weighted average shares outstanding, basic 4,617,665 750,582 4,205,469 530,131 Net income (loss) per share, diluted $ 0.07 $ (7.55 ) $ (0.19 ) $ (21.14 ) Weighted average shares outstanding, diluted 4,885,845 750,582 4,205,469 530,131 SOURCE: Sonnet BioTherapeutics, Inc. View the original press release on accesswire.com

临床1期财报临床结果AACR会议

2024-03-19

·药明康德

毛发再生疗法7天即可激活休眠毛囊干细胞；疾病控制率达100%的小分子抑制剂… | 一周盘点

▎药明康德内容团队编辑本期看点1. 新型局部外用小分子疗法PP405的早期临床结果表明，该疗法能重新激活休眠的毛囊干细胞，诱发毛发生长，有望治疗各类型脱发。2. 第三代小分子MEK抑制剂IMM-1-104用于治疗晚期携带RAS突变的实体肿瘤患者的早期临床结果亮眼，100%的患者未产生获得性RAS变异，超半数患者观察到靶病灶的消退。3. 口服HSF1信号通路抑制剂NXP800用于治疗铂类耐药、携带ARID1a突变的卵巢癌患者的1b期试验结果积极，疾病控制率达100%。药明康德内容团队整理PP405：公布1期临床试验数据Pelage Pharmaceuticals公司公布了其新型局部外用小分子疗法PP405的转化研究和1期临床研究的积极数据。PP405是一种强效的局部线粒体丙酮酸载体（MPC）抑制剂，可作用于细胞代谢通路以上调乳酸脱氢酶（LDH）。干细胞对LDH尤为敏感，LDH的上调能够激活干细胞并促进毛发生长。此次公布的数据证明该公司的新型局部外用小分子疗法PP405能重新激活休眠的毛囊干细胞，诱发毛发生长。在接受过面部提升去皱手术的皮肤上，单次外用0.006%和0.06%的PP405可在24小时内提高毛囊干细胞的LDH活性。LDH活性与毛发隆起处Ki67信号的显著增加相对应，表明毛囊干细胞有增殖反应。此外，1期研究还在雄激素性脱发患者中证明了机理和靶点作用。仅在0.05% PP405局部治疗7天后，Ki67信号与基线相比就出现了具有统计学意义的升高。研究人员还观察到新生毛基质（毛发生长周期中由休止期向生长期转变的标志）。Pelage公司将于2024年中期启动PP405的多中心2a期临床试验，招募患有雄激素性脱发的男女患者。PP405还可用于其他类型的脱发，包括休止期脱发（由压力引起的脱发）和化疗引起的脱发。IMM-1-104：公布1/2a期临床试验数据Immuneering公司宣布，其高选择性第三代小分子MEK抑制剂IMM-1-104治疗晚期携带RAS突变的实体肿瘤患者的1/2a期试验取得了积极的顶线结果。IMM-1-104是一款靶向MAPK通路中重要激酶MEK的抑制剂，旨在通过每日一次给药对MAPK通路进行抑制。这次所公布的试验共有41位患者入组，其中胰腺癌患者占63.4%、结直肠癌患者占12.2%、肺癌患者占9.76%。试验中有82%的患者在接受过往治疗时未曾达到部分缓解（PR）或完全缓解（CR）。截至2024年2月20日的数据，IMM-1-104在41例受试者中的耐受性良好，且具有差异化的安全性。22名接受循环肿瘤DNA（ctDNA）检测并接受IMM-1-104治疗的可评估患者中，100%未出现新的获得性RAS变异，支持其具有泛RAS活性。在每天320 mg或240 mg剂量组中，53%的患者观察到靶病灶的消退。在二线治疗中，320 mg剂量组的最佳的患者肿瘤病变消退为-35.7%，240 mg剂量组中为-11.4%；320 mg剂量组的最佳RECIST肿瘤最长直径之和（SLD）减少了18.9%，240 mg剂量组中减少了7.1%。候选的推荐2期剂量（RP2D）为每日一次320 mg，该RP2D得到耐受性、ctDNA、药代动力学（PK）和药效（PD）特征和初始抗肿瘤活性等积极结果的支持。NXP800：公布1b期临床试验的初步数据Nuvectis Pharma公司公布了其开发的口服HSF1通路小分子抑制剂NXP800用于治疗铂类耐药、携带ARID1a突变的卵巢癌患者的1b期临床试验的积极结果。HSF1是一款应激诱导的转录因子，HSF1信号通路在肿瘤发生中起到重要作用，是多项研究验证的抗癌药物靶点。在针对多种类型的晚期实体肿瘤患者开展的1a期试验中，NXP800的临床概况与临床前实验的预期高度一致，没有报告与药物相关的4级或5级事件。此前，NXP80在铂类耐药、携带ARID1a突变卵巢癌中的开发项目已被美国FDA授予快速通道资格。此次公布的结果显示，3名可评估患者的疾病控制率为100%，缓解率为33%。其中，1名达到未确认的PR患者的淋巴结非靶病灶获得了CR。ATSN-201：公布1/2期临床试验首个队列的数据ATSN-201是Atsena Therapeutics公司利用其新型扩散衣壳AAV.SPR开发的基因疗法，用于治疗X连锁视网膜劈裂症（XLRS）。XLRS是由RS1基因的突变引起的，该基因编码一种名为retinoschisin的蛋白，这是一种主要由光感受器分泌的蛋白质，位于视杆细胞、视锥细胞和双极细胞的外表面。XLRS的特点是视网膜层的异常分裂，这会导致视力受损，且无法通过眼镜矫正，随后会导致进行性的视力丧失。该病目前尚无批准的治疗方法。ATSN-201使用的病毒衣壳能够横向扩散到视网膜下注射点以外的位置，实现对中央视网膜的安全和有效的基因递送（在XLRS患者的视网膜中，分裂腔主要集中在中央视网膜部位）。此前的研究显示，AAV.SPR在临床剂量下能够有效递送载荷至视网膜中央凹上的视锥细胞，无需手术分离，并且不会引起炎症。此次公布的数据显示，ATSN-201在1/2期临床试验首个队列的所有3名患者中耐受性良好，没有报告严重不良事件。数据和安全监测委员会建议继续进行第二组，以测试下一个剂量水平的ATSN-201。RGLS8429：公布1b期临床试验数据Regulus Therapeutics公司公布了其开发的新型下一代寡核苷酸疗法RGLS8429用于治疗常染色体显性多囊肾病（ADPKD）的1b期临床试验的新数据。常染色体显性多囊肾病是由PKD1或PKD2基因突变引起的，也是最常见的人类单基因疾病之一，同时是终末期肾病的主要原因。RGLS8429旨在抑制miR-17并优先靶向肾脏，在临床前研究中已被证明能够明显改善肾脏功能、大小和其他疾病严重程度指标，并具有优越的药理学特征。此前，该公司已公布1期单次递增剂量临床试验的结果，结果显示，RGLS8429具有良好的安全性、耐受性和PK特征。此次公布的是1b期研究中第二个队列的结果，患者对RGLS8429的耐受性良好，未发现令人担忧的安全性问题。基于尿液生物标志物分析结果，在2 mg/kg剂量水平下观察到RGLS8429的生物活性。基于影像学的生物标志物的探索性结果令人鼓舞，在PC1和PC2增加最多的患者中，总肾脏体积减少的幅度最大。PC1和PC2是PKD1和PKD2基因的蛋白质产物，已被证明与疾病严重程度呈负相关。Sabirnetug（ACU193）：公布1期临床试验的新数据Acumen Pharmaceuticals公司公布了其新药sabirnetug用于治疗阿尔茨海默病（AD）的1期临床试验的新数据。Sabirnetug是一种选择性靶向毒性可溶性β淀粉样蛋白寡聚体（AβOs）的选择性人源化单克隆抗体。Sabirnetug能够结合AβOs，由于其独特的结合特性，sabirnetug有可能在产生淀粉样蛋白相关成像异常（ARIA，一种抗体疗法产生的常见主要副作用）风险较低的情况下提供治疗益处，因为sabirnetug可以在不直接靶向淀粉样斑块的情况下阻断AβOs的毒性作用。2023年7月公布的结果显示，该试验的初步结果达到了主要和次要目标，为sabirnetug的临床机制验证提供了证据。在较高剂量组的患者中观察到淀粉样斑块快速、剂量相关的显著减少（p=0.01），每四周给药一次60 mg/kg sabirnetug组患者的淀粉样斑块在第63天减少了25%，每两周给药一次25 mg/kg sabirnetug组患者的淀粉样斑块在第70天减少了20%。这一结果与已批准的Aß单克隆抗体在其临床开发阶段相似时间点的平均淀粉样蛋白斑块减少相当。此次公布的脑脊液生物标志物结果显示，与接受安慰剂治疗的患者相比，接受sabirnetug治疗的早期AD患者大脑中与AD病理学相关的生物标志物得到了改善，神经粒蛋白（neurogranin）水平降低了13.9%，p-tau181水平降低了13.0%，Aβ42/40比率呈上升趋势。在所有剂量中，AβOs的靶点作用与神经粒蛋白以及p-tau181的变化之间均存在显著的相关性，高度支持sabirnetug在早期AD患者大脑中的下游药理作用。该公司计划在2024年上半年启动sabirnetug的2期临床试验。ATR-258 Atrogi：公布1a/b期临床试验数据Atrogi公司宣布，其新型β2肾上腺素受体（β2-AR）激动剂ATR-258治疗2型糖尿病（T2D）患者的1a/b期临床试验达到了所有终点。ATR-258可与β2-AR结合，启动葡萄糖向骨骼肌运输的过程，从而降低血糖水平，并对受T2D影响的多个器官产生积极影响。这种专有的小分子化合物以一种新颖的方式激活受体，导致选择性调节和独特的信号传导特征。这种创新方法使解决2型糖尿病的核心问题成为可能。临床前研究表明，它能有效地将2型糖尿病状态逆转到健康水平。KIO-101：公布1期临床试验数据KIO-101是Kiora Pharmaceuticals公司的一种靶向二氢乳清酸脱氢酶（DHODH）的下一代非甾体类免疫调节小分子抑制剂，旨在克服市售的DHODH抑制剂的相关脱靶副作用和安全问题。此次公布的结果显示，使用12天KIO-101滴眼液在24名健康受试者中的安全性和耐受性良好，没有观察到严重的不良事件。与安慰剂组相比，治疗组的结膜充血明显减少。结膜充血是眼部炎症的体征，由多种非感染性和感染性原因引起。大家都在看药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看）[1] Pelage Presents Late-Breaking Data at AAD 2024 Meeting Demonstrating PP405 Activates Human Hair Follicle Stem Cells Ex Vivo and in Phase 1 Clinical Study. Retrieved March 11, 2024, from https://www.prnewswire.com/news-releases/pelage-presents-late-breaking-data-at-aad-2024-meeting-demonstrating-pp405-activates-human-hair-follicle-stem-cells-ex-vivo-and-in-phase-1-clinical-study-302084610.html[2] Arrowhead Pharmaceuticals Initiates Phase 1/2a Study of ARO-DM1 for Treatment of Type 1 Myotonic Dystrophy. Retrieved March 11, 2024, from https://www.businesswire.com/news/home/20240308355853/en/[3] Acumen Pharmaceuticals Presents Sabirnetug (sabirnetug) Fluid Biomarker and Target Engagement Analyses from Phase 1 INTERCEPT-AD Study in Early Alzheimer’s at the AD/PD™ 2024 Annual Meeting. Retrieved March 11, 2024, from https://investors.acumenpharm.com/news-releases/news-release-details/acumen-pharmaceuticals-presents-sabirnetug-acu193-fluid[4] Kiora Announces Publication of Phase 1 Study Demonstrating Safety, Tolerability and Anti-Inflammatory Activity of KIO-101 in the Treatment of Inflammation of the Eye. Retrieved March 11, 2024, from https://ir.kiorapharma.com/news-events/press-releases/detail/207/kiora-announces-publication-of-phase-1-study-demonstrating[5] ImmunAbs Announces Conclusion of Phase 1 Clinical Trial, Revealing Positive Topline Results. Retrieved March 11, 2024, from https://www.prnewswire.com/news-releases/immunabs-announces-conclusion-of-phase-1-clinical-trial-revealing-positive-topline-results-302084998.html[6] Allyx Therapeutics Announces Positive Phase 1b Multiple Ascending Dose Data and Advances ALX-001 to Patients. Retrieved March 11, 2024, from https://www.globenewswire.com/news-release/2024/03/11/2843754/0/en/Allyx-Therapeutics-Announces-Positive-Phase-1b-Multiple-Ascending-Dose-Data-and-Advances-ALX-001-to-Patients.html[7] Aprea Therapeutics Announces FDA Clearance of IND for APR-1051, its Next Generation WEE1 Kinase Inhibitor for Cyclin E Overexpressing Cancers. Retrieved March 11, 2024, from https://www.globenewswire.com/news-release/2024/03/11/2843764/0/en/Aprea-Therapeutics-Announces-FDA-Clearance-of-IND-for-APR-1051-its-Next-Generation-WEE1-Kinase-Inhibitor-for-Cyclin-E-Overexpressing-Cancers.html[8] Sonnet BioTherapeutics Announces Early Safety Data from the Company’s Phase 1b/2a Clinical Trial of SON-080 in Chemotherapy-Induced Peripheral Neuropathy (CIPN) Met the Study’s Initial Pre-Specified Objective. Retrieved March 11, 2024, from https://www.sonnetbio.com/news-media/press-releases/detail/84/sonnet-biotherapeutics-announces-early-safety-data-from-the[9] Sonnet BioTherapeutics Announces Early Safety Data from the Company’s Phase 1b/2a Clinical Trial of SON-080 in Chemotherapy-Induced Peripheral Neuropathy (CIPN) Met the Study’s Initial Pre-Specified Objective. Retrieved March 11, 2024, from https://www.sonnetbio.com/news-media/press-releases/detail/84/sonnet-biotherapeutics-announces-early-safety-data-from-the[10] EILEAN THERAPEUTICS APPROVED TO INITIATE FIRST PATIENT TRIAL WITH BALAMENIB (ZE63-0302), A SELECTIVE BEST-IN-CLASS MENIN INHIBITOR. Retrieved March 11, 2024, from https://www.prnewswire.com/news-releases/eilean-therapeutics-approved-to-initiate-first-patient-trial-with-balamenib-ze63-0302-a-selective-best-in-class-menin-inhibitor-302085538.html[11] Synnovation Therapeutics Announces First Patient Dosed in Phase I Trial with SNV1521, a PARP1 Selective Inhibitor for the Treatment of Solid Tumors. Retrieved March 11, 2024, from https://www.businesswire.com/news/home/20240311306666/en/[12] Nurix Therapeutics Announces U.S. FDA Lifts Partial Clinical Hold on NX-2127 Phase 1 TrialNurix cleared to introduce new chirally controlled NX-2127 drug product and resume enrollment of new patients into the study. Retrieved March 11, 2024, from https://ir.nurixtx.com/news-releases/news-release-details/nurix-therapeutics-announces-partial-clinical-hold-nx-2127-phase[13] Replay’s cell therapy product company Syena announces first patient dosed in Phase 1/2 study of TCR-NK cell therapy for multiple myeloma. Retrieved March 11, 2024, from https://replay.bio/news/replays-cell-therapy-product-company-syena-announces-first-patient-dosed-in[14] Regulus Therapeutics Announces Positive Topline Data from the Second Cohort of Patients in its Phase 1b Multiple-Ascending Dose (MAD) Clinical Trial of RGLS8429 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). Retrieved March 11, 2024, from https://www.prnewswire.com/news-releases/regulus-therapeutics-announces-positive-topline-data-from-the-second-cohort-of-patients-in-its-phase-1b-multiple-ascending-dose-mad-clinical-trial-of-rgls8429-for-the-treatment-of-autosomal-dominant-polycystic-kidney-disease-ad-302086081.html[15] Atsena Therapeutics Announces Initiation of Dosing in Second Cohort of Phase I/II Clinical Trial Evaluating ATSN-201 Gene Therapy for the Treatment of X-linked Retinoschisis (XLRS). Retrieved March 14, 2024, from https://www.tmcnet.com/usubmit/2024/03/13/9977428.htm [16] Ocugen, Inc. Announces Dosing Completion of Subjects with Geographic Atrophy in Cohort 1 of Phase 1/2 Clinical Trial Evaluating the Safety and Efficacy of OCU410. Retrieved March 14, 2024, from https://ir.ocugen.com/news-releases/news-release-details/ocugen-inc-announces-dosing-completion-subjects-geographic[17] Clearmind Medicine Obtains Clearance for its Psychedelic- Based Alcoholism Clinical Trial. Retrieved March 14, 2024, from https://www.clearmindmedicine.com/news-release/clearmind-medicine-obtains-clearance-for-its-psychedelic--based-alcoholism-clinical-trial[18] Immuneering Announces Positive Topline Results from Phase 1 Portion of its Phase 1/2a Clinical Trial of IMM-1-104 in RAS-Mutant Solid Tumors. Retrieved March 14, 2024, from https://www.globenewswire.com/news-release/2024/03/14/2846143/0/en/Immuneering-Announces-Positive-Topline-Results-from-Phase-1-Portion-of-its-Phase-1-2a-Clinical-Trial-of-IMM-1-104-in-RAS-Mutant-Solid-Tumors.html[19] Nuvectis Pharma Announces Encouraging Preliminary Data from the NXP800 Phase 1b Clinical Trial in Platinum-Resistant ARID1a-Mutated Ovarian Cancer. Retrieved March 14, 2024, from https://www.globenewswire.com/news-release/2024/03/14/2846324/0/en/Nuvectis-Pharma-Announces-Encouraging-Preliminary-Data-from-the-NXP800-Phase-1b-Clinical-Trial-in-Platinum-Resistant-ARID1a-Mutated-Ovarian-Cancer.html[20] Atrogi Announces Positive Clinical Data from First-in-Class Insulin-Independent Treatment for Type 2 Diabetes. Retrieved March 14, 2024, from https://www.globenewswire.com/news-release/2024/03/14/2846027/0/en/Atrogi-Announces-Positive-Clinical-Data-from-First-in-Class-Insulin-Independent-Treatment-for-Type-2-Diabetes.html[21] Atrogi Announces Positive Clinical Data from First-in-Class Insulin-Independent Treatment for Type 2 Diabetes. Retrieved March 14, 2024, from https://www.globenewswire.com/news-release/2024/03/14/2846027/0/en/Atrogi-Announces-Positive-Clinical-Data-from-First-in-Class-Insulin-Independent-Treatment-for-Type-2-Diabetes.html[22] Nuvation Bio Doses First Patient in Phase 1/2 Study of NUV-1511 for the Treatment of Advanced Solid Tumors. Retrieved March 14, 2024, from https://www.businesswire.com/news/home/20240314331030/en免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床2期临床结果临床1期

2024-03-19

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Sonnet BioTherapeutics to Present Preclinical Data on SON-080 for Chemotherapy-Induced Peripheral Neuropathy (CIPN) at the AACR 2024 Annual Meeting

PRINCETON, NJ / ACCESSWIRE / March 19, 2024 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, announced today that preclinical data and clinical trial design from the study of SON-080 (recombinant human Interleukin-6 or rhIL-6) in CIPN will be presented in a poster session at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2023, to be held April 5-10, in San Diego, California. Presentation details: Title: Low dose interleukin-6 (SON-080) for neuropathies: Toxicology and clinical plans Session Title: Pharmacology and Pharmacogenetics Presentation Type: Poster Session Date and Time: Wednesday April 10, 2024, 9:00 AM - 12:30 PM Abstract Number: 7181 Location: Poster Section 24 Poster Board Number: 22 About Sonnet BioTherapeutics Holdings, Inc. Sonnet BioTherapeutics is an oncology-focused biotechnology company with a proprietary platform for innovating biologic drugs of single or bifunctional action. Known as FHAB (Fully Human Albumin Binding), the technology utilizes a fully human single chain antibody fragment (scFv) that binds to and "hitch-hikes" on human serum albumin (HSA) for transport to target tissues. Sonnet's FHAB was designed to specifically target tumor and lymphatic tissue, with an improved therapeutic window for optimizing the safety and efficacy of immune modulating biologic drugs. FHAB is the foundation of a modular, plug-and-play construct for potentiating a range of large molecule therapeutic classes, including cytokines, peptides, antibodies, and vaccines. Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's cash runway, the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Sonnet BioTherapeutics Investor Contact: Jack Yauch Solebury Strategic Communications 862-754-1024 jyauch@soleburystrat.com SOURCE: Sonnet BioTherapeutics, Inc. View the original press release on accesswire.com

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适应症	最高研发状态	国家/地区	公司	日期
周围神经系统疾病	临床2期	美国	Sonnet BioTherapeutics CH SA	2022-01-30
糖尿病性神经病变	临床2期	-	Weizmann Institute of Science	-
糖尿病性神经病变	临床2期	-	RELIEF THERAPEUTICS Holding SA	-
糖尿病性神经病变	临床2期	-	Xequel Bio, Inc.	-
糖尿病性神经病变	临床2期	-	Merck Serono SA	-
周围神经损伤	临床1期	瑞士	-	2016-07-12
糖尿病周围神经病变	临床前	美国	Sonnet BioTherapeutics CH SA	2022-01-30

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


SP096 (ERA2014)	N/A	NGAL	6	rhIL-6 infusion	糧鏇繭願鹹鹹顧醖憲獵(鏇窪築淵壓鑰餘餘簾壓) = 簾餘窪餘範窪艱獵鹹鬱獵鬱製憲選築艱蓋範艱 (醖蓋鑰齋膚壓糧艱膚觸, 114.6 ~ 186.7) 更多	-	2014-05-01
				Placebo	糧鏇繭願鹹鹹顧醖憲獵(鏇窪築淵壓鑰餘餘簾壓) = 網築構製蓋顧窪製簾襯獵鬱製憲選築艱蓋範艱 (醖蓋鑰齋膚壓糧艱膚觸, 0.6 ~ 1.2) 更多