A 2 Part Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Pharmacokinetics of SAD/MAD Oral Doses of SRP-3D (DA), and to Characterize the Effect of Food on the Pharmacokinetics in Healthy Male and Female Subjects

This is a two-part randomized, double-blind, placebo-controlled study.

开始日期2022-05-16

申办/合作机构

South Rampart Pharma LLC初创企业

100 项与 SRP 3D (diethylamide) 相关的临床结果

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100 项与 SRP 3D (diethylamide) 相关的转化医学

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100 项与 SRP 3D (diethylamide) 相关的专利（医药）

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项与 SRP 3D (diethylamide) 相关的文献（医药）

2023-05-04·Research square

Transcriptomic signature, bioactivity and safety of a non-hepatoxic analgesic generating AM404 in the mid-brain PAG region.

作者: Bazan, Hernan ; Pierre, Linsey St ; Alvarez-Builla, Julio ; Desai, Neehar ; Polk, Connor ; Jun, Bokkyoo ; Bazan, Nicolas ; Strain, Madeleine ; Reid, Madigan ; Edwards, Scott ; Cai, James ; Bhattacharjee, Surjyadipta ; Cucinello-Ragland, Jessica ; Daly, Patrick

The safe and effective management of pain is a critical healthcare and societal need. The potential for misuse and addiction associated with opioids, nephrotoxicity, and gastrointestinal damage from chronic non-steroidal anti-inflammatory drug (NSAID) use, as well as acute liver injury from paracetamol (ApAP) overdose, are unresolved challenges. To address them, we developed a non-opioid and non-hepatotoxic small molecule, SRP-001. Compared to ApAP, SRP-001 is not hepatotoxic as it does not produce N-acetyl-p-benzoquinone-imine (NAPQI) and maintains hepatic tight junction integrity at high doses. SRP-001 has comparable analgesia in pain models, including the complete Freund's adjuvant (CFA) inflammatory von Frey. Both induce analgesia via N-arachidonoylphenolamine (AM404) formation in the midbrain periaqueductal grey (PAG) nociception area, with SRP-001 generating higher amounts of AM404 than ApAP. Single-cell transcriptomics of PAG uncovered that SRP-001 and ApAP also share modulation of pain-related gene expression and cell signaling pathways, including the endocannabinoid, mechanical nociception, and fatty acid amide hydrolase (FAAH) pathways. Both regulate the expression of key genes encoding FAAH, 2-AG, CNR1, CNR2, TRPV4, and voltage-gated Ca2+ channel. Interim Phase 1 trial results demonstrate SRP-001's safety, tolerability, and favorable pharmacokinetics (NCT05484414). Given its non-hepatotoxicity and clinically validated analgesic mechanisms, SRP-001 offers a promising alternative to ApAP, NSAIDs, and opioids for safer pain treatment.

项与 SRP 3D (diethylamide) 相关的新闻（医药）

2024-05-19

·药明康德

24周100%患者体重减轻超5%的减肥疗法；完全缓解率近70%的CAR-T疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点1. 罗氏（Roche）公布了其潜在“best-in-class”减重疗法CT-388在1/2期临床试验中的亮眼数据，经过24周每周一次的CT-388皮下注射治疗，100%患者的体重降低幅度超过5%，平均体重降低幅度达18.8%，具有临床与统计学意义。2. Rocket Pharmaceuticals公司公布了3项在研基因疗法的积极数据，其中两款疗法已分别在美国和欧洲递交上市许可申请。3. 在自体CAR-T细胞疗法NXC-201用于治疗复发/难治性轻链（AL）淀粉样变性的1b/2a期临床试验中，患者的总缓解率（ORR）为92%，完全缓解（CR）率接近70%。药明康德内容团队整理CT-388：公布1/2期临床试验数据罗氏公布了其在研、潜在“best-in-class”葡萄糖依赖性促胰岛素多肽（GIP）和胰高血糖素样肽-1（GLP-1）受体双重激动剂CT-388用于治疗肥胖和2型糖尿病患者的1期临床试验的积极数据。CT-388是一种每周一次皮下注射的GLP-1/GIP受体双重激动剂，旨在对GLP-1和GIP受体均具有强效活性，但最小化β-arrestin募集至任一受体。这种偏向信号可显著减少受体内化和随之而来的脱敏现象，预计可延长药物的药理活性。该疗法有望成为单药或与其他疗法结合使用，以改善体重减轻效果，并可能扩展至其他适应症。罗氏在2023年12月斥资约31亿美元收购Carmot Therapeutics，囊获多款包含CT-388在内处于临床开发阶段的皮下和口服肠促胰岛素疗法。此次公布的结果显示，与安慰剂相比，每周皮下注射一次CT-388并持续24周可使肥胖健康成年人体重显著减轻。CT-388所取得的减重效果具有临床意义，经安慰剂调整后的平均减重效果为18.8%（p<0.001）。在第24周，100%接受CT-388治疗的受试者实现了超过5%的体重减轻，85%实现了超过10%，70%实现了超过15%，45%实现了超过20%的体重减轻。此外，所有基线时处于糖尿病前期状态的受试者在接受CT-388治疗24周后血糖均恢复正常，而接受安慰剂治疗的受试者的血糖状态在此期间基本保持不变。安全性方面，CT-388展现良好的耐受性，最常见的是轻度至中度胃肠道相关不良事件，这与CT-388所属的肠促胰岛素（incretins）类药物中所观察到的一致。RP-L201、RP-L102、RP-L301：公布积极早期临床数据 Rocket Pharmaceuticals在美国基因和细胞治疗学会（ASGCT）年会中公布了数款慢病毒（LV）载体基因疗法的最新数据。分析显示，其用以治疗严重白细胞粘附缺陷-I（LAD-I）的基因疗法Kresladi（marnetegragene autotemcel），与用以治疗范可尼贫血（FA）的RP-L102皆在1/2期关键研究中展现良好的有效性与安全性。其另一款用以治疗丙酮酸激酶缺乏症（PKD）的在研基因疗法RP-L301也在1期试验中展现积极结果。▲接受Kresladi治疗的LAD-I患者发生严重感染而需要住院的发生率大幅下降（图片来源：参考资料[12]）▲接受RP-L102治疗的FA患者的疾病表型获得校正（图片来源：参考资料[12]）▲接受RP-L301治疗的PKD患者的血红蛋白水平获得改善（图片来源：参考资料[12]）目前，美国FDA正在对Kresladi用以治疗LAD-I的生物制品许可申请（BLA）进行审评，PDUFA目标日期为2024年6月30日。同时，欧洲药品管理局（EMA）也已接收RP-L102的上市许可申请（MAA），Rocket预计将在2024年上半年向美国FDA提交相关BLA。NXC-201（HBI0101）：公布1b/2a期临床试验的新数据Immix Biopharma公司公布了其子公司Nexcella公司开发的靶向BCMA的自体CAR-T细胞疗法NXC-201的1b/2a期临床试验的新数据。该研究旨在评估NXC-201用于治疗复发/难治性AL淀粉样变性的安全性和有效性。此前，NXC-201已被FDA授予孤儿药资格，用于治疗AL淀粉样变性和多发性骨髓瘤（MM）。此次公布的数据显示，复发/难治性AL淀粉样变性患者的ORR为92%（12/13），12例既往未接受过BCMA靶向双特异性治疗的患者均对NXC-201有应答，近69.2%（9/13）的患者获得了CR。1例既往接受过BCMA靶向双特异性治疗的患者对NXC-201没有应答。截至2024年5月10日，最佳缓解者的缓解持续时间已达28.0个月，并仍在持续获得缓解。安全性方面，未发生免疫效应细胞相关神经毒性综合征（ICANS）事件，细胞因子释放综合征（CRS）的中位持续时间为2天（范围：1-5）。ION582：布1/2a期临床试验数据Ionis Pharmaceuticals公司宣布，其反义寡核苷酸（ASO）疗法ION582用于治疗天使综合征（Angelman syndrome）的1/2a期开放标签研究HALOS获得了积极的顶线数据。天使综合征由来自母体的UBE3A等位基因功能丧失引起，表现为严重的运动、语言和认知功能发育迟缓、癫痫发作和共济失调，导致患者完全依赖护理人员。ION582是一款通过脊椎穿刺鞘内给药的ASO疗法，旨在激活来自父体的UBE3A等位基因，从而增加大脑中UBE3A蛋白的产生。此次公布的结果究表明，ION582在所有剂量水平下均显示良好的安全性和耐受性，并在认知、沟通和运动技能等关键功能领域显示出令人鼓舞和一致的益处。接受治疗6个月后，大约65%的患者在Bayley-4认知评估（一种由医生进行的临床功能客观评估）中显示出改善，超过了同一时期疾病自然史研究中观察到的改善。大约70%的患者在Bayley-4的接受性和/或表达性沟通评估中显示出改善。大约65%的患者在Bayley-4的运动技能评估中显示出改善。RBI-4000：公布1期临床试验数据Replicate Bioscience公司公布了其在研RNA疫苗RBI-4000的1期临床试验的积极结果。RBI-4000是一款基于自我复制RNA（srRNA）的狂犬病疫苗，旨在刺激针对狂犬病病毒的中和免疫反应，用于预防狂犬病感染。在临床前研究中，肌肉注射RBI-4000可提供针对狂犬病病毒的持久保护，诱导抗体生成和产生强大的病毒特异性T细胞。这次公布的结果显示，接受一剂疫苗后，92%的受试者达到了世界卫生组织（WHO）定义的替代保护指标，接受两剂疫苗后，100%的受试者都达到了WHO定义的替代保护指标。安全性方面，RBI-4000在所有队列中都具有良好的耐受性，没有严重的不良事件。此外，未观察到剂量限制性毒性。新闻稿指出，Replicate公司的新型srRNA载体可扩大RNA技术在疫苗以外的生物治疗蛋白模板化表达方面的应用，如用于治疗免疫疾病、代谢疾病和癌症等。IMA203：公布1期临床试验数据 Immatics公司在2024年第一季度的财务报告上公布了其在研T细胞受体T细胞（TCR-T）疗法IMA203用以治疗经治转移性黑色素瘤患者的最新数据。IMA203是由Immatics专有ACTengine平台所开发的TCR-T细胞，靶向由HLA-A*02呈递的黑素瘤抗原PRAME。PRAME是一种在各种实体瘤中经常表达的蛋白质，因此IMA203具潜力治疗广泛的癌症患者群体。此次公布的分析结果显示，87%的患者实现肿瘤缩小，患者的确认ORR达55%。Immatics计划在2024年下半年的医学会议上，提供IMA203的下一次临床数据更新。同时，该公司亦计划在与美国FDA进一步讨论后，于今年启动IMA203作为二线及以上疗法，治疗黑色素瘤患者的注册性2/3期临床试验。 ▲IMA203的疗效结果（图片来源：参考资料[5]）ProtheraCytes：公布1/2b期临床试验数据 CellProthera日前宣布，其主打在研产品ProtheraCytes在一项针对严重心肌梗死（AMI）患者的1/2b期研究中获得积极结果。ProtheraCytes来源于从患者外周血中采集的CD34阳性干细胞，这些细胞能促进血管再生，调节炎症、细胞凋亡和心肌细胞再生，并有望诱导受损心肌组织的修复过程。此次公布的数据显示，接受治疗6个月后，包括梗死面积、左心室尺寸和NT-proBNP水平在内的预后生物标志物的积极变化支持ProtheraCytes在心肌梗死后有心力衰竭风险患者中的疗效。研究人员表示，这一结果支持在更大规模的3期临床试验中评估ProtheraCytes的效果。Vepdegestrant（ARV-471）：公布1b期临床试验的新数据 Arvinas公司和辉瑞（Pfizer）公布了在研雌激素受体（ER）PROTAC蛋白降解剂vepdegestrant（ARV-471）联合CDK4/6抑制剂Ibrance（palbociclib）的1b期临床试验的积极数据。作为一款口服、靶向降解ER的蛋白降解剂，vepdegestrant可在肿瘤细胞内降解几乎所有的ER分子，并在许多ER驱动的动物肿瘤模型中，引起肿瘤大量的缩小。该试验入组患者为局部晚期或转移性雌激素受体阳性/人表皮生长因子2阴性（ER+/HER2-）乳腺癌患者，既往接受过中位4线治疗。这次所公布的数据是去年12月所公布数据的额外6个月随访数据更新。分析显示，接受联合疗法乳腺癌患者的ORR为41.9%，中位无进展生存期（PFS）为11.2个月，显示vepdegestrant联合palbociclib治疗乳腺癌的潜力。INI-2004：公布1b期临床试验数据 Inimmune公司公布了INI-2004用于治疗过敏性鼻炎的1b期多剂量递增研究的最新结果。INI-2004是一种不针对特定过敏原的免疫疗法，能结合并激活TLR4。经鼻内给药后，INI-2004可显著降低临床前动物模型的过敏性鼻炎指标，包括气道阻力、嗜酸性粒细胞流入以及与过敏性鼻炎发病机制有关的细胞因子的产生。该研究纳入了35例对豚草过敏的受试者。此次公布的结果显示，与接受安慰剂相比，接受INI-2004治疗的受试者在接触到豚草后，鼻塞情况显示出剂量依赖性的改善。与接受安慰剂相比，接受INI-2004治疗的受试者的鼻拭子样本中细胞因子生物标志物具有呈剂量依赖性的升高趋势。此外，在多次给药过程中，所有剂量的INI-2004均具有良好的耐受性，没有达到最大耐受量。SRP-001：公布1期临床试验数据 South Rampart Pharma公司公布了其潜在“best-in-class”的非阿片类镇痛药SRP-001的1期随机对照试验的积极结果。SRP-001能够触发中脑PAG区域形成AM404，AM404是辣椒素受体（TRPV1）的一种强效激活剂，而TRPV1在大脑对疼痛的反应中起着至关重要的作用。SRP-001提供了一种不会像阿片类药物那样被滥用的潜在有效的镇痛解决方案，该疗法也不会出现肝脏毒性和肾脏毒性问题。此前，SRP-001获得了美国FDA授予的快速通道资格，用于治疗急性疼痛。此次公布的结果显示，SRP-001的安全性和耐受性良好，具有良好的药代动力学，使其可用于治疗神经性疼痛、急性/慢性疼痛和急性偏头痛患者。该疗法用于治疗急性疼痛的2期试验计划于2024年下半年启动。▲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] Immix Biopharma Announces Positive NXC-201 Relapsed/Refractory AL Amyloidosis Clinical Data in ASGCT 2024 Late Breaking Oral Presentation. 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Retrieved May 15, 2024, from https://www.cellprothera.com/en/cellprothera-announces-positive-phase-i-iib-data-for-protheracytes-cell-therapy-in-acute-myocardial-infarction/[14] Genprex Doses First Patient in Acclaim-3 Clinical Study of Reqorsa® Immunogene Therapy in Combination with Tecentriq® to Treat Small Cell Lung Cancer. Retrieved May 15, 2024, from https://www.prnewswire.com/news-releases/genprex-doses-first-patient-in-acclaim-3-clinical-study-of-reqorsa-immunogene-therapy-in-combination-with-tecentriq-to-treat-small-cell-lung-cancer-302144415.html[15] Delix Announces DLX-001 Demonstrates Evidence of CNS Penetration and Brain Activity Without Psychotomimetic, Dissociative, or Hallucinogenic Effects in Ongoing Phase 1 Trial. Retrieved May 15, 2024, from https://www.businesswire.com/news/home/20240513298581/en[16] Ryvu Therapeutics to present clinical and preclinical data on RVU120 at the 2024 European Hematology Association Congress. Retrieved May 15, 2024, from https://www.prnewswire.com/news-releases/ryvu-therapeutics-to-present-clinical-and-preclinical-data-on-rvu120-at-the-2024-european-hematology-association-congress-302145195.html[17] CASI Pharmaceuticals Receives FDA Clearance On The Investigational New Drug (IND) Application For CID-103 In Immune Thrombocytopenia (ITP). Retrieved May 15, 2024, from https://www.prnewswire.com/news-releases/casi-pharmaceuticals-receives-fda-clearance-on-the-investigational-new-drug-ind-application-for-cid-103-in-immune-thrombocytopenia-itp-302145848.html[18] Replicate Bioscience Presents Positive Data from Phase 1 Trial and Preclinical Data with Novel Self-Replicating RNA at the 2024 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting. Retrieved May 17, 2024, from https://www.prnewswire.com/news-releases/replicate-bioscience-presents-positive-data-from-phase-1-trial-and-preclinical-data-with-novel-self-replicating-rna-at-the-2024-american-society-of-gene--cell-therapy-asgct-annual-meeting-302142558.html[19] Ionis announces positive topline results from Phase 1/2a trial of ION582 for Angelman syndrome. Retrieved May 16, 2024, from https://ir.ionispharma.com/news-releases/news-release-details/ionis-announces-positive-topline-results-phase-12a-trial-ion582[20] Arvinas and Pfizer Announce Updated Clinical Data from Phase 1b Trial of Vepdegestrant in Combination with Palbociclib (IBRANCE®). Retrieved May 16, 2024 from https://ir.arvinas.com/news-releases/news-release-details/arvinas-and-pfizer-announce-updated-clinical-data-phase-1b-trial[21] [Ad hoc announcement pursuant to Art. 53 LR] Roche reports positive Phase I results for its dual GLP-1/GIP receptor agonist CT-388 in people with obesity. Retrieved May 16, 2024 from https://www.globenewswire.com/news-release/2024/05/16/2883079/0/en/Ad-hoc-announcement-pursuant-to-Art-53-LR-Roche-reports-positive-Phase-I-results-for-its-dual-GLP-1-GIP-receptor-agonist-CT-388-in-people-with-obesity.html[22] INIMMUNE ANNOUNCES SUCCESSFUL PHASE 1 CLINICAL RESULTS FOR DISEASE MODIFYING ALLERGY TREATMENT, INI-2004. Retrieved May 16, 2024 from https://www.prnewswire.com/news-releases/inimmune-announces-successful-phase-1-clinical-results-for-disease-modifying-allergy-treatment-ini-2004-302145985.html[23] South Rampart Pharma Publishes SRP-001's Unique Pain Relief Mechanism and Phase 1 Trial Results in Scientific Reports. Retrieved May 16, 2024 from https://www.globenewswire.com/news-release/2024/05/16/2883210/0/en/South-Rampart-Pharma-Publishes-SRP-001-s-Unique-Pain-Relief-Mechanism-and-Phase-1-Trial-Results-in-Scientific-Reports.html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

细胞疗法基因疗法临床结果免疫疗法临床2期

2024-05-16

·BioSpace

South Rampart Pharma Publishes SRP-001's Unique Pain Relief Mechanism and Phase 1 Trial Results in Scientific Reports

SRP-001 is a novel, non-opioid new chemical entity without abuse, liver, and kidney toxicities present in current pain medications Publication introduces SRP-001 as a safer alternative to existing pain medications SRP-001 triggers N-arachidonoylphenolamine (AM404) formation in the midbrain's periaqueductal grey (PAG) region, a potent activator of TRPV1 that plays a crucial role in the brain’s response to pain FDA awarded SRP-001 Fast Track designation for acute pain in October 2023 Phase 1 trial shows SRP-001 is safe and well-tolerated with favorable pharmacokinetics making it Phase 2-ready for the treatment of neuropathic pain, acute/chronic pain, and patients with acute migraine headaches. A Phase 2 trial in acute pain will launch in the second half of 2024 NEW ORLEANS, May 16, 2024 (GLOBE NEWSWIRE) -- South Rampart Pharma, Inc., today announced the publication of a paper in Scientific Reports describing the manner in which SRP-001 works in the brain to alleviate pain and the results of a Phase 1 randomized controlled trial (RCT)1. The study, by Bazan et al., is titled, "Transcriptomic signature, bioactivity and safety of a non-hepatotoxic analgesic generating AM404 in the midbrain PAG region." The publication reveals SRP-001's unique mechanism of action, producing higher amounts of N-arachidonoylphenolamine (AM404) than acetaminophen, a metabolite crucial for inducing pain relief in the midbrain’s periaqueductal grey (PAG) region. This discovery is supported by comprehensive preclinical evaluations, including in vitro and in vivo assessments of liver, kidney, and other end-organ toxicities, pain-relieving effects in pre-clinical models, alongside a completed Phase 1 RCT in 56 human subjects showcasing the compound's safety, tolerability, and robust pharmacokinetics (PKs). Key findings in the published paper include: SRP-001 treatment induces the formation of AM404 in the midbrain's PAG region, a potent activator of TRPV1 that has a crucial role in the brain and dorsal horn's response to pain. Single-cell transcriptomics of the PAG region uncovered that SRP-001 regulates pain-related gene expression and cell signaling networks, including endocannabinoid signaling, genes pertaining to mechanical nociception, and fatty acid amide hydrolase (FAAH). The mechanical nociception and FAAH networks regulate the expression of critical genes encoding FAAH, 2-arachidonoylglycerol (2-AG), cannabinoid receptor 1 (CNR1), CNR2, transient receptor potential vanilloid type 4 (TRPV4), and voltage-gated Ca2+ channel. SRP-001 lacks hepatotoxicity due to an absence of NAPQI formation and hepatic tight junctions’ integrity protection. As a non-NSAID, it lacks this class’s risks of kidney and gastrointestinal damage with overuse. Comprehensive genotoxicity, safety pharmacology, and non-clinical toxicology evaluations, including ICH-compliant studies and GLP toxicity studies in two animal species, confirm SRP-001’s non-genotoxic nature, lack of adverse effects on pulmonary or cardiac functions and absent treatment-related adverse effects or mortality in dose-escalating studies. A completed Phase 1 RCT involving 56 subjects with single and multiple ascending dosing demonstrates that SRP-001 is safe and well-tolerated, with a half-life of up to 10.1 hours. “The quest for innovative pain solutions is critical, driven by the extensive prevalence of acute, chronic, and neuropathic pain,” said Hernan Bazan, M.D., the study’s lead author, South Rampart’s co-founder and CEO, and the John Ochsner Endowed Professor of Cardiovascular Innovation at Ochsner Health. “These pain conditions affect up to 27% of adults worldwide, including over 51 million adults in the U.S. Existing treatments such as opioids, acetaminophen, and NSAIDs pose risks of addiction and toxicity with overuse. Armed with known mechanisms for pain relief in the brain and compelling Phase 1 randomized trial data, we look forward to advancing SRP-001 into Phase 2 randomized and controlled studies for acute and neuropathic pain in the second half of 2024.” About the Publication Bazan HA et al. Transcriptomic signature, bioactivity and safety of a non-hepatotoxic analgesic generating AM404 in the midbrain PAG region. Sci Rep 14, 11103 (2024). DOI: 10.1038/s41598-024-61791-z About Acute, Chronic, and Neuropathic Pain Acute, chronic, and neuropathic pain constitute significant yet distinctly different health challenges. Acute pain is the body's immediate alert to injury, typically intense but temporary. In contrast, chronic pain persists beyond three months, affecting an estimated 51.6 million U.S. adults in 2021 and nearly one-third of the global population. Neuropathic pain, resulting from nerve damage, affects approximately 7-10% of people worldwide. Traditional treatments, such as opioids, acetaminophen/paracetamol, and NSAIDs, while common, often fall short in efficacy and carry risks like addiction and organ damage. The opioid epidemic, characterized by 8.7 million Americans misusing prescription opioids, underscores the urgent need for safer, more effective pain management solutions. These pain categories not only compromise individual well-being but also impose a substantial economic toll, highlighting the critical need for innovation in pain treatment strategies. About Migraine Migraine is a widespread and complex neurological condition, affecting nearly 40 million Americans and over 1 billion people globally. It ranks as the primary cause of disability among individuals under 50. Characterized by severe, throbbing headaches, migraine episodes can last from four hours to three days. These episodes often feature incapacitating symptoms such as intense pulsating pain, nausea, vomiting, and heightened sensitivity to light and sound, significantly impacting daily life. About SRP-001 The Company’s lead program, SRP-001, is a best-in-class analgesic that garnered FDA Fast-Track Designation for acute pain in October 2023. It uniquely targets the midbrain’s PAG region, offering a potentially effective pain relief solution devoid of the abuse potential of opioids, liver toxicity associated with acetaminophen, and kidney toxicity from NSAIDs overuse. A completed Phase 1 randomized controlled clinical trial data demonstrates the safety and robust pharmacokinetics for SRP-001 [ClinicalTrials.gov Identifier: NCT05484414], setting the stage for simultaneous Phase-2 ready programs in neuropathic and acute pain in 2H 2024, as well as migraine headache. South Rampart Pharma, Inc. South Rampart Pharma, Inc. is a clinical-stage biopharmaceutical company at the forefront of advancing the effective and safe treatment of pain by developing first-in-class novel small molecule therapeutics. It aims to mitigate the prevalent risks of existing pain medications, such as addiction and organ damage. The Company’s pipeline of novel compounds has effectively reduced pain and fever in pre-clinical studies without the abuse of non-opioid analgesics and the liver and kidney toxicities of current pain medicines. 1HA Bazan et al. Transcriptomic signature, bioactivity, and safety of a non-hepatotoxic analgesic generating AM404 in the midbrain PAG region. Sci Rep. DOI: 10.1038/s41598-024-61791-z (2024). Investors: Josh Blacher, MBA Chief Financial Officer jblacher@southrampartpharma.com Media: Michael Rubenstein LifeSci Communications mrubenstein@lifescicomms.com

临床1期快速通道临床2期

2024-05-16

·Outsourcing Pharma

South Rampart Pharma's quest to deliver innovative non-opioid pain solutions

The drug, SRP-001’s promising results from its phase 1 trial were also published. The announcement was made by South Rampart Pharma Inc. and the study was led by Hernan Bazan, co-founder and CEO of South Rampart. It was titled “Transcriptomic signature, bioactivity and safety of a non-hepatotoxic analgesic generating AM404 in the midbrain PAG region,” and reveals that SRP-001 produces higher amounts of N-arachidonoylphenolamine (AM404) in the midbrain's periaqueductal grey (PAG) region than acetaminophen. This metabolite is crucial for inducing pain relief. SRP-001 is highlighted as a safer alternative to existing pain medications, avoiding the abuse potential, liver toxicity, and kidney toxicity present in current treatments. According to comprehensive preclinical evaluations and a completed phase 1 randomized controlled trial (RCT) involving 56 human subjects, SRP-001 has demonstrated safety, tolerability, and robust pharmacokinetics. These evaluations showed no adverse effects on liver, kidney, or other end-organs, making SRP-001 a significant addition to the pain management landscape. “The quest for innovative pain solutions is critical, driven by the extensive prevalence of acute, chronic, and neuropathic pain,” said Dr Bazan. “These pain conditions affect up to 27% of adults worldwide, including over 51 million adults in the U.S. Existing treatments such as opioids, acetaminophen, and NSAIDs pose risks of addiction and toxicity with overuse. Armed with known mechanisms for pain relief in the brain and compelling Phase 1 randomized trial data, we look forward to advancing SRP-001 into phase 2 randomized and controlled studies for acute and neuropathic pain in the second half of 2024.” googletag.cmd.push(function () { googletag.display('text-ad1'); }); Company to launch phase 2 trial in acute pain SRP-001 has been shown to trigger the formation of AM404, a potent activator of TRPV1 in the midbrain's PAG region, which plays a crucial role in the brain’s response to pain. Additionally, single-cell transcriptomics of the PAG region revealed that SRP-001 regulates pain-related gene expression and cell signaling networks, including endocannabinoid signaling and genes related to mechanical nociception and fatty acid amide hydrolase (FAAH). The publication also emphasizes that SRP-001 avoids hepatotoxicity due to the absence of NAPQI formation and protects hepatic tight junction integrity. It does not carry the risks of kidney and gastrointestinal damage associated with NSAID overuse. Comprehensive genotoxicity, safety pharmacology, and non-clinical toxicology evaluations, including ICH-compliant studies and GLP toxicity studies in two animal species, confirm SRP-001’s non-genotoxic nature and absence of adverse effects on pulmonary or cardiac functions. The completed phase 1 RCT demonstrated that SRP-001 is safe and well-tolerated, with a half-life of up to 10.1 hours. With the FDA awarding SRP-001 Fast Track designation for acute pain in October 2023, the company is set to launch a phase 2 trial in acute pain in the second half of 2024, targeting neuropathic pain, acute/chronic pain, and patients with acute migraine headaches. South Rampart Pharma, Inc. is a clinical-stage biopharmaceutical company committed to advancing the effective and safe treatment of pain by developing first-in-class novel small molecule therapeutics. The company aims to mitigate the prevalent risks of existing pain medications, such as addiction and organ damage, through its pipeline of novel compounds that have shown efficacy in reducing pain and fever in pre-clinical studies without the associated toxicities of current pain medicines.

临床1期临床结果快速通道临床2期

100 项与 SRP 3D (diethylamide) 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
疼痛	临床1期	美国	South Rampart Pharma LLC初创企业	2022-05-16

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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


NCT05484414 (Biospace) 人工标引	临床1期	急性疼痛	56	SRP-001	簾鹹夢齋網構鹽獵積夢(鏇鏇積窪憲廠觸顧繭製) = 範簾繭壓膚遞選範廠餘顧積願簾網鹽襯鹹淵襯 (襯廠鬱繭願顧願衊鏇淵 )	积极	2024-01-02
				placebo	-