Randomized, Double-blind, Placebo-controlled, 28-Day Daily-dose Crossover Study of the Safety and Tolerability of SB-121 (Lactobacillus Reuteri With Sephadex® and Maltose) in Subjects, Ages 15 to 45 Years, Diagnosed With Autistic Disorder

SB-121 is being developed for use in the treatment of autistic disorder (AD).
This study is a multiple-dose, randomized, double-blind, placebo-controlled, cross-over single-site Phase I study.
The primary objective is to evaluate the safety and tolerability of multiple doses of SB-121 in subjects ages 15 to 45 years with AD.
Additionally, multiple measures of AD, as well as mechanistic biomarkers, will be assessed in order to inform later stage trials.

开始日期2021-08-02

申办/合作机构

Scioto Biosciences, Inc.初创企业

100 项与 SB-121 相关的临床结果

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100 项与 SB-121 相关的转化医学

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100 项与 SB-121 相关的专利（医药）

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项与 SB-121 相关的文献（医药）

2023-03-30·Scientific reports

Results of a phase Ib study of SB-121, an investigational probiotic formulation, a randomized controlled trial in participants with autism spectrum disorder.

Article

作者: Schmitt, Lauren M ; Trebley, Joe ; Horn, Paul S ; Erickson, Craig A ; Barber, Lillian ; Ahuja, Sanjeev ; Hughes, Phoevos ; Will, Meredith ; Lamy, Martine ; Pedapati, Ernest V ; Heiman, Mark ; Meyer, Kevin ; Smith, Elizabeth G ; West, Korbin H J

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by core impairments in social communication as well as restricted, repetitive patterns of behavior and/or interests. Individuals with ASD, which includes about 2% of the US population, have challenges with activities of daily living and suffer from comorbid medical and mental health concerns. There are no drugs indicated for the core impairments of ASD. As such, there is a significant need for the development of new medication strategies for individuals with ASD. This first-in-human placebo-controlled, double-blind, crossover study investigated the safety (primary objective) and efficacy of oral SB-121, a combination of L. reuteri, Sephadex® (dextran microparticles), and maltose administered once daily for 28 days in 15 autistic participants. SB-121 was safe and well tolerated. SB-121-associated directional improvements in adaptive behavior measured by Vineland-3 and social preference as measured with eye tracking were noted. These results provide support for further clinical evaluation of SB-121 as a treatment in autistic patients. To evaluate the safety and tolerability of multiple doses of SB-121 in subjects with autism spectrum disorder. Single-center, randomized, placebo-controlled, double-blind, crossover trial. 15 patients with autism spectrum disorder were randomized and analyzed. Daily dosing of SB-121 or placebo for 28 days, followed by approximately a 14 day washout, then 28 days of dosing with other treatment. Incidence and severity of adverse events, presence of Limosilactobacillus reuteri and Sephadex® in stool, and incidence of bacteremia with positive L. reuteri identification. Additional outcomes include changes from baseline on cognitive and behavior tests as well as biomarker levels. Adverse event rates were similar between SB-121 and placebo, with most reported as mild. There were no severe or serious adverse events. No participants had features of suspected bacteremia or notable changes in vital signs, safety laboratory, or ECG parameters from baseline. There was a statistically significant increase from baseline in the Vineland-3 Adaptive Behavior Composite score (p = 0.03) during SB-121 treatment. There was a trend for increased social/geometric viewing ratio following SB-121 treatment compared to placebo. SB-121 was safe and well tolerated. SB-121-associated directional improvements in adaptive behavior measured by Vineland-3 and social preference as measured with eye tracking were noted.Trial registration: clinicaltrials.gov Identifier: NCT04944901.

2012-07-01·Wei sheng yan jiu = Journal of hygiene research

[Rapid determination of 19 elements in human urine by inductively coupled plasma-mass spectrometry with dynamic reaction cell].

Article

作者: Liu, Huijian ; Liao, Qinqin ; Wang, Jun ; Xu, Jian ; Liu, Xiaoli ; Tan, Hongxing

OBJECTIVE:

A simple method is proposed for determination of Be, Rb, Sr, Cd, Pb, Cs, Tl, V, Cr, Mn, Ni, Co, Cu,Zn, Sn, Sb, Te, As and Se in urine by using inductively coupled plasma mass spectrometry with dynamic reaction cell.

METHODS:

Prior to analysis, samples were diluted (1: 20) in a solution of nitric acid (3%, V/V). The DRC mode was applied to determine the content of V51, Cr52, Mn55, Ni58, Co59, Cu63, Zn64 Sn120, Sb121, Te130, As75 and Se80. For the other elements, the instrument was operated in standard mode.

RESULTS:

The method detection limits were 2.7ng/L for Be9, 2.0ng/L for V51, 2.7ng/L for Cr52, 1.5ng/L for Mn55, 3.9ng/L for Ni58, 0.8ng/L for Co59, 5.8ng/L for Cu63, 35.3ng/L for Zn64, 32.4ng/L for As75, 21.1ng/L for Se80,1.4ng/L for Rb85, 4.2ng/ L for Sr88, 1.1 ng/L for Cd 9.1 ng/L for Sn120, 1.1ng/L for Sb121, 8.6ng/L for Te130, 0.1 ng/L for Cs133, 0.2ng/L for Tl205 and 1.0 ng/L for Pb208. The precisions of the method were in the range of 0.3% - 2.6%.

CONCLUSION:

The proposed method was rapid, accurate and can be used for measurement with simple pre-treatment, less sample and lower cost. The method was also suitable for massive samples in screening and monitoring.

2006-05-14·The Journal of chemical physics2区 · 化学

The quadrupole moment of the Sb nucleus from molecular microwave data and calculated relativistic electric-field gradients

2区 · 化学

Article

作者: Kello, Vladimir ; Sadlej, Andrzej J. ; Demovic, Lukas ; Cooke, Stephen A.

The recently determined accurate values of the nuclear quadrupole coupling constant of the Sb nucleus in SbN, SbP, SbF, and SbCl and the calculated electric-field gradients at Sb in these molecules are used to obtain the nuclear quadrupole moment of Sb121 and Sb123. The calculation of the electric-field gradient has been carried out by using the infinite-order two-component relativistic method in the scalar approximation. The accompanying change of picture of the electric-field gradient operator has been accounted for by employing the shifted nucleus model of nuclear quadrupoles. The electron correlation effects are calculated at the level of the coupled cluster approximation. The present calculations give the “molecular” value of the nuclear quadrupole moment of Sb121 equal to −556±24mb which is considerably different from the old “recommended” value of −360±40mb and also differs from the recent “solid-state” result (−669±15mb). The validation of the present data is comprehensively discussed.

项与 SB-121 相关的新闻（医药）

2023-10-23

·Science Daily

Probiotics delivered in biofilm state protect the intestines and brain in NEC model

Researchers have been working on a novel solution to prevent NEC. They have developed a novel probiotic system that harnesses the durability of biofilms to improve the administration of probiotics to patients. Their latest study describes the use of a biofilm formulation of Limosilactobacillus reuteri (Lr) to prevent NEC in a piglet model. Necrotizing enterocolitis (NEC) is a debilitating and deadly condition that affects infants who were born preterm. In NEC cases, intestinal tissues become inflamed, and in severe cases there is ischemia and death of the involved intestines. Treatment for NEC often involves surgery to remove the dying tissue. "Even after decades of research, little has changed in terms of prognosis for infants who develop NEC," says Gail Besner, MD, pediatric surgeon and principal investigator in the Center for Perinatal Research at Nationwide Children's. "Anywhere from 30 to 50% of infants with NEC will die from it. And even those who survive face lifelong challenges including short-gut syndrome and neurodevelopmental delays." ]Dr. Besner and her collaborators Michael Bailey, PhD, and Steven Goodman, PhD, both principal investigators in the Center for Microbial Pathogenesis at Nationwide Children's, have been working on a novel solution to prevent NEC. They have developed a novel probiotic system that harnesses the durability of biofilms to improve the administration of probiotics to patients. It has been licensed to Scioto Biosciences. Their latest study, published in Nature Scientific Reports, describes the use of a biofilm formulation of Limosilactobacillus reuteri (Lr) to prevent NEC in a piglet model. "Our previous studies have shown that the biofilm probiotic works in mouse and rat models," says Dr. Besner. "But there are many examples where researchers find something that works in rodents, but it fails to translate to humans. We wanted to show that this approach to preventing NEC would work in an animal model that was more similar to humans." Dr. Besner and her team therefore adapted the very challenging piglet model of NEC into her laboratory for this study. Notably, preterm piglets and preterm humans are very similar in terms of size and intestinal anatomy. Care that would normally be given to a preterm infant, including medications and fluids, nasogastric (NG) tube feedings, and round-the-clock monitoring, are all included in the model. The data from the piglet model validated findings in rodent models. Findings demonstrate the superiority of Lr in its biofilm state compared to planktonic (free-living) Lr in preventing the morbidity and mortality associated with NEC. Importantly, Lr in its biofilm state not only protects the intestines from NEC, but protects the brain as well, a finding of great potential importance for survivors of NEC. "The piglet is an excellent model to help prepare for studies in neonates. The data from this study help us understand the safety and efficacy pro this novel formulation. This will be helpful as we work with the FDA to plan for future human studies," says Joe Trebley, PhD, founder and chief executive officer of Scioto Biosciences. A similar probiotic formulation developed by the team, SB-121, has been tested in a clinical trial in adults with autism spectrum disorder (ASD). The association between the brain and the gut symptoms in autism has been well-established in the literature, with more than half of people with autism also experiencing abdominal problems. The study, which primarily evaluated the safety of SB-121, also found that some participants showed treatment-driven improvements in their ASD test outcomes. The promising results of that phase 1b trial were published earlier this year in Nature Scientific Reports. "Taken together, the current piglet study, the previous rodent studies, and the recent SB-121 clinical trial provide a solid foundation for pursuing a clinical trial in neonates at risk of developing NEC," says Dr. Besner. "We are excited to continue pursuing this research with the hope that someday, infants born preterm will have more options to protect them from NEC." This research was funded through a $2.3M SBIR grant from the National Institute of General Medical Sciences at the National Institutes of Health. Drs. Besner, Bailey and Goodman are all scientific founders of Scioto Biosciences.

临床1期临床结果

2023-04-09

·药明康德

治疗阿尔茨海默病的免疫疗法；潜在“first-in-class”渐冻症反义寡核苷酸疗法... | 一周盘点

▎药明康德内容团队编辑本期看点1. Alzamend Neuro公司宣布启动免疫治疗疫苗ALZN002的1/2a期临床试验，用于治疗轻中度阿尔茨海默病。2. QurAlis公司宣布，其反义寡核苷酸疗法QRL-201在治疗肌萎缩侧索硬化症（ALS）的临床1期试验中已完成首位患者给药。3. Scioto Biosciences宣布，在Scientific Reports上发表了其益生菌疗法SB-121治疗自闭症谱系障碍（ASD）患者的1b期研究结果。药明康德内容团队整理ALZN002：1/2a期试验启动Alzamend Neuro公司宣布启动免疫治疗疫苗ALZN002的1/2a期临床试验，用于治疗轻中度阿尔茨海默病。该临床试验主要目的为确定2b期临床试验中所使用ALZN002的适当剂量。ALZN002是一种专有的“主动”免疫治疗产品，意味着它是由每个患者的免疫系统产生的。它由自体树突状细胞（DCs）组成，这些DCs是从每个患者的血液中分离出激活的白细胞，然后在体外改造成攻击阿尔茨海默病相关淀粉样蛋白的细胞。它们旨在增强患者的免疫系统对抗阿尔茨海默病的能力。在增加治疗安全性与耐受性同时，刺激免疫系统减少脑中β淀粉样蛋白的负担，从而减轻阿尔茨海默症状。与使用外来血液制品（如单克隆抗体）的被动免疫治疗方法相比，使用ALZN002的主动免疫治疗可能在淀粉样蛋白清除方面产生更强大和持久的效果，以及频率较少的治疗次数。QRL-201：1期试验首位病患给药QurAlis公司宣布，其在研疗法QRL-201在治疗肌萎缩侧索硬化症的ANQUR临床1期试验中已完成首位患者给药。QRL-201是一款潜在“first-in-class”疗法，旨在恢复ALS患者体内的STATHMIN-2（STMN2）表达。根据新闻稿，ANQUR是第一项评估拯救ALS患者STMN2表达的治疗方法的试验。ALS是一种严重的神经退行性疾病，治疗选择有限。STMN2对神经修复和轴突稳定非常重要，其表达在几乎所有ALS患者中都显著降低。STMN2又称SCG-10，是稳定微管的蛋白质，微管是细胞和轴突细胞骨架的重要组成部分。STMN2在人类运动神经元中高度表达，这些神经元是ALS患者主要退化的细胞。在动物模型中，STMN2缺失导致轴突退化和肌肉内神经支配的丧失，这是导致ALS患者瘫痪的主要功能缺陷。在来自ALS患者的人类神经干细胞模型中，研究人员发现STMN2的表达受TDP-43的调控。此外，正常TDP-43功能的丧失会导致STMN2表达显著下降，并导致神经修复能力受损，通过恢复STMN2水平可拯救这种功能缺陷。这些研究结果已发表在《自然神经科学》上。SB-121：1b期试验结果期刊发表Scioto Biosciences宣布，在Scientific Reports杂志上发表了其在研益生菌疗法SB-121在自闭症谱系障碍（ASD）患者中的1b期研究结果。自闭症谱系障碍（ASD）是一种神经发育性障碍，其核心障碍为社交沟通和互动的受损，同时伴随着行为和/或兴趣的限制性、重复性模式。这项人体1期试验是一项双盲、安慰剂对照的交叉研究，旨在评估SB-121的安全性和耐受性。SB-121是一种新型口服Lactobacillus reuteri（Lr）制剂，用以治疗确诊ASD的15至45岁的患者。Lr是一种常在母乳中发现的细菌。试验结果显示SB-121具良好的安全性和耐受性。该结果还观察到患者治疗相关Vineland-3自适应行为评估的改善、眼球追踪的测量和外周催产素水平的增加。催产素是一种天然荷尔蒙，除了许多其他功能外，还可以促进结合和社交互动。VO659：1/2a期试验首位病患给药Vico Therapeutics宣布，VO659的1/2a期临床试验已完成首名患者给药。这项研究使用VO659治疗亨廷顿病（HD）、1型脊髓小脑性共济失调（SCA1）和3型脊髓小脑性共济失调（SCA3）。VO659是一种反义寡核苷酸（ASO）在研药物，旨在靶向导致包括HD、SCA1和SCA3在内的所有已知多谷氨酸疾病的CAG重复扩增。新闻稿指出，VO659是首个靶向导致这些疾病的CAG重复扩增的临床候选药物。VO659的设计旨在优先降低突变的HTT基因并保护野生型HTT基因。VO659的独特靶标和双重作用机制使其能够在多种疾病模型中实现强大的靶向作用。在HD的疾病小鼠模型中，临床前研究观察到mHTT蛋白的显著、剂量依赖性降低和运动功能改善。在HD患者细胞模型中，亦观察到优先降低编码mHTT的等位基因表达。此外，VO659在SCA1和SCA3的疾病小鼠模型和患者细胞模型中均能够显著降低突变ATXN1（mATXN1）和突变ATXN3（mATXN3）蛋白的水平。NEO-201：1期试验结果期刊发表Precision Biologics宣布其靶向截短的核心1 O-糖基（core-1 O-glycan）单克隆抗体NEO-201的1期临床试验结果发表在国际期刊Journal of Experimental and Clinical Cancer Research上。基于NEO-201良好的安全性和活性，2期试验病患正在招募当中，包含那些已接受过检查点抑制剂治疗的转移性非小细胞肺癌（NSCLC）、头颈癌、子宫内膜癌和宫颈癌患者。过去研究结果显示，它能够杀死表达其靶点的癌细胞。在1期临床试验中，发现NEO-201能够减少难治性实体肿瘤患者的免疫抑制细胞数量，这些细胞可能削弱检查点抑制剂的癌细胞杀伤活性。正在进行的2期试验旨在测试NEO-201与Keytruda联合使用时是否能够提高检查点抑制剂的有效性。RLYB211：1/2期概念验证结果发表Rallybio公司宣布，其用于预防胎儿及新生儿同种异体免疫性血小板减少症（FNAIT）的在研抗体RLYB211临床1/2期试验的概念证明研究结果发表在国际血栓与止血学会官方期刊Journal of Thrombosis and Haemostasis上。FNAIT是一种罕见且危及生命的出血性疾病，是因母体免疫球蛋白靶向胎儿血小板而导致严重的胎儿/新生儿不良事件，目前尚无批准治疗FNAIT的方法。RLYB211为靶向HPA-1a的人源性多克隆抗体。这项随机单盲、安慰剂对照的试验检视了静脉单次注射RLYB211对于消除健康受试者体内HPA-1a阳性血小板的能力，这些受试者为HPA-1a阴性，是经由输注后体内带有HPA-1a阳性血小板。在队列1中，受试者在输注HPA-1a阳性血小板1小时后接受RLYB211或安慰剂治疗，而在队列1B中，受试者则是在接受RLYB211或安慰剂治疗后一周接受血小板输注。结果显示，RLYB211加速HPA-1a阳性血小板的清除，与安慰剂组相比，所有接受RLYB211治疗的受试者符合血小板清除半衰期超过90％下降的概念验证标准。在RLYB211给药7天后，血小板的快速清除效果亦明显，此试验设计是用以模拟在胎儿出血之前预防性给予抗HPA-1a抗体的状况。此外，RLYB211耐受性良好，未报告任何严重不良事件。KSI-501：1期试验首位病患给药Kodiak Sciences公司宣布首位患者接受了在研双特异性抗体KSI-501的1期试验治疗。KSI-501是一种新型的双特异性抗体生物聚合物结合物，同时靶向VEGF和IL-6。这项1期试验是一项开放标签的多剂量递增研究，最初招募的患者患有糖尿病黄斑水肿（DME）。试验主要目的是评估药物对眼部和全身的安全性，并确定最大耐受剂量。在临床前细胞实验中，KSI-501可抑制血管生成，同时正常化内外眼底血管屏障；与单一抗VEGF或抗IL-6抗体相比，KSI-501双重抑制VEGF和IL-6能显著改善细胞形态和细胞间连接的正常化。MYTX-011：1期试验首位病患给药Mythic Therapeutics宣布完成其在研抗体偶联药物（ADC）MYTX-011在1期临床试验KisMET-01的首位患者给药。MYTX-011正被检视用于治疗局部晚期、复发或转移性NSCLC患者的疗效与安全性。MYTX-011是通过Mythic创新的FateControl技术平台所开发的cMET靶向ADC，此技术可使得ADC主动导航到细胞内，从而可能增加抗癌药物对肿瘤细胞的输送，并降低对健康细胞的影响。LNK01003：1期试验结果公布Lynk Pharmaceuticals宣布其自主研发的创新肠道限制性JAK抑制剂LNK01003已完成在中国健康受试者的1期试验。该研究结果显示，该药物具有良好的安全性、耐受性和药代动力学性能。LNK01003是一种口服小分子JAK抑制剂，具有肠道限制性特性，开发用于治疗溃疡性结肠炎和相关疾病。通过将药物暴露限制在胃肠道，加上高系统清除，可以避免药物因全身免疫抑制引起的副作用。由于该药物在胃肠组织中的浓度较高，它可以最大限度地抑制多种在炎症性肠病中发挥作用的炎性细胞因子。因此，LNK01003具有提高治疗效果的潜力。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] Alzamend Neuro Announces the Initiation of a Phase I/IIA Trial for Its Immunotherapy Vaccine (ALZN002) to Treat Mild to Moderate Dementia of the Alzheimer’s Type. Retrieved April 8, 2023 from https://www.businesswire.com/news/home/20230403005570/en/Alzamend-Neuro-Announces-the-Initiation-of-a-Phase-IIIA-Trial-for-Its-Immunotherapy-Vaccine-ALZN002-to-Treat-Mild-to-Moderate-Dementia-of-the-Alzheimer%E2%80%99s-Type[2] QurAlis Announces First Patient Dosed With QRL-201, a First-in-Class STATHMIN-2 Precision Therapy for ALS. Retrieved April 8, 2023 from https://www.prnewswire.com/news-releases/quralis-announces-first-patient-dosed-with-qrl-201-a-first-in-class-stathmin-2-precision-therapy-for-als-301790444.html[3] Scioto Biosciences Announces Publication of Phase 1b Study in Autism. Retrieved April 9, 2023 from https://www.businesswire.com/news/home/20230403005103/en/[4] Vico Therapeutics Announces First Patient Dosed in Phase 1/2a Clinical Trial of VO659 in Huntington's Disease and Spinocerebellar Ataxia Types 1 and 3. Retrieved April 9, 2023 from https://www.prnewswire.com/news-releases/vico-therapeutics-announces-first-patient-dosed-in-phase-12a-clinical-trial-of-vo659-in-huntingtons-disease-and-spinocerebellar-ataxia-types-1-and-3-301787046.html[5] Precision Biologics Announces Publication Of First-In-Human Phase 1 Clinical Trial With NEO-201. Retrieved April 9, 2023 from https://www.businesswire.com/news/home/20230403005855/en/[6] Rallybio Announces Clinical Proof-of-Concept Results for RLYB211, an Anti-HPA-1a Polyclonal Antibody for the Prevention of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT), Published in the Journal of Thrombosis and Haemostasis. Retrieved April 9, 2023 from https://www.businesswire.com/news/home/20230403005712/en/[7] Kodiak Sciences Expands Development Pipeline with Treatment of First Patient in Phase 1 Clinical Study of KSI-501, an Investigational Bispecific Antibody Biopolymer Conjugate for Retinal Diseases. Retrieved April 9, 2023 from https://www.prnewswire.com/news-releases/kodiak-sciences-expands-development-pipeline-with-treatment-of-first-patient-in-phase-1-clinical-study-of-ksi-501-an-investigational-bispecific-antibody-biopolymer-conjugate-for-retinal-diseases-301787940.html[8] Mythic Therapeutics Announces First Subject Dosed in Phase 1 KisMET-01 Clinical Trial of cMET-Targeting Antibody-Drug Conjugate (ADC) MYTX-011 for the Treatment of Non-Small Cell Lung Cancer (NSCLC). Retrieved April 9, 2023 from https://www.businesswire.com/news/home/20230404005018/en/[9] Lynk Pharmaceuticals Announces Positive Results for LNK01003 in Phase I Trial in Healthy Subjects. Retrieved April 9, 2023 from https://www.prnewswire.com/news-releases/lynk-pharmaceuticals-announces-positive-results-for-lnk01003-in-phase-i-trial-in-healthy-subjects-301788958.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

临床2期免疫疗法临床结果寡核苷酸临床1期

2023-04-03

·BioSpace

Scioto Biosciences Announces Publication of Phase 1b Study in Autism

"Results of a phase Ib study of SB-121, an investigational probiotic formulation, a randomized controlled trial in participants with autism spectrum disorder" FISHERS, Ind.--(BUSINESS WIRE)-- Scioto Biosciences Inc., (the “Company” or “Scioto Biosciences”) a clinical stage company developing innovative therapies to transform the delivery of microbiome therapeutics, today announced the publication of results from a Phase 1b study of their lead product SB-121 in patients with Autistic Spectrum Disorder (ASD). The publication, Results of a phase Ib study of SB-121, an investigational probiotic formulation, a randomized controlled trial in participants with autism spectrum disorder, was published in the journal Scientific Reports. Scientific Reports, a part of Nature Publishing, is an open access journal requiring a rigorous peer-review process prior to publication. According to its website, Scientific Reports is the 5th most cited journal in the world with more than 696,000 citations in 2021. The top-line results of the study were announced last summer. The first-in-human study was double-blind, placebo controlled, 28-day crossover study of the safety and tolerability of SB-121. SB-121 is a novel formulation of Lactobacillus reuteri (Lr) and was given to patients 15 to 45 years of age diagnosed with ASD. Lr is a species of bacteria that is often found in breastmilk. With the results now published, the study demonstrated that SB-121 was safe and well-tolerated. The study also showed treatment-associated improvements in the Vineland-3 adaptive behavior assessment, measures of eye tracking and increases in peripheral oxytocin. Oxytocin is a natural hormone that, among many functions, encourages bonding and social interaction. The study was performed by Dr. Craig Erickson MD at the Cincinnati Children’s Hospital. Dr. Erickson is the corresponding author on the paper. Additional authors include Lauren Schmitt PhD, Elizabeth Smith PhD, Ernest Pedapati MD MS, Paul Horn PhD, Meredith Will PhD, Martine Lamy MD PhD, and Lillian Barber from Cincinnati Children’s Hospital and Joe Trebley PhD, Kevin Meyer, Mark Heiman PhD, Korbin West PhD, Phoevos Hughes JD, and Sanjeev Ahuja MD from Scioto Biosciences. “We are very pleased to have this study accepted for publication. It is an exciting result that certainly warrants further investigation in a larger Phase II study. We look forward to continuing to help move this forward in the clinic so that we can eventually get it to the patients that so desperately need it,” said Dr. Erickson. “Scioto is incredibly grateful for the team at Cincinnati Children’s Hospital. We are proud to have published this important work alongside them. The peer-review process is such a critical part of science. It is incredibly gratifying to have this study published in such a well-cited journal,” explained Joe Trebley, PhD, CEO of the Company. Trebley also said that hope to begin a Phase II study in the 2nd half of this year. According to the Center for Disease Control (CDC) about 1 in 44 children have been identified with ASD, and prevalence in adults continues to grow creating the bulk of the economic burden of the disorder. Estimates of economic costs in the US only are in the 100’s of billions of dollars. About Scioto Biosciences Based in Fishers, IN, Scioto Biosciences is a clinical stage company developing innovative therapies devoted to having a transformative impact on the delivery of live bacterial therapeutics (LBTs). Scioto Biosciences was founded in 2017 as a partnership between Indiana business accelerator, Monon Bioventures (MBV) and The Research Institute at Nationwide Children's Hospital (RINCH), with whom the company has a worldwide exclusive licensing agreement. The Company’s Activated Bacterial Therapeutic Platform has the potential to enhance efficacy wherever LBTs are used such as neurological disorders, gastrointestinal health, and others. For more information, visit

临床1期引进/卖出临床2期临床结果微生物疗法

100 项与 SB-121 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
自闭症	临床1期	美国	Scioto Biosciences, Inc.初创企业	2021-08-02
艰难梭菌感染	临床前	美国	Scioto Biosciences, Inc.初创企业	2018-11-05

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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


NCT04944901 (CTgov)	临床1期	自闭症	15	SB-121 (SB-121)	醖廠齋遞築積觸壓襯膚(蓋構獵齋觸鑰築鑰衊繭) = 淵鏇選蓋膚糧觸範獵醖願鏇繭顧範獵鏇衊醖夢 (積網構積鹹網齋膚網廠, 艱鏇壓憲簾顧鬱蓋鑰繭 ~ 襯鬱膚鹹鹽廠壓糧艱衊) 更多	-	2024-03-25
				Placebo (Placebo)	醖廠齋遞築積觸壓襯膚(蓋構獵齋觸鑰築鑰衊繭) = 醖簾膚選夢艱顧壓壓糧願鏇繭顧範獵鏇衊醖夢 (積網構積鹹網齋膚網廠, 醖夢襯願齋鬱鹹鹽鑰餘 ~ 艱膚顧構築願淵窪壓顧) 更多
NCT04944901 (Corporate Publications) 人工标引	临床1期	自闭症谱系障碍一线	-	SB-121	齋鹽廠衊製廠餘憲襯獵(襯製糧壓餘選艱遞積範) = 網鑰蓋鹽醖窪鏇簾鏇蓋繭鏇襯網憲獵淵襯積鑰 (製繭獵獵膚鹹糧範製網 )	积极	2022-05-26
				Placebo	-