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Scioto Biosciences, Inc. Announces First Patient Dosed in Phase Ib Study in Patients Diagnosed with Autistic Disorder

INDIANAPOLIS–(BUSINESS WIRE)–Scioto Biosciences, Inc. announced the beginning of their Phase Ib clinical trial for their lead investigational product SB-121 for the treatment of Autistic Disorder (AD). The first patient was randomized and started dosing in mid-August. Scioto is an innovation-driven biotechnology company focused on developing a novel microbiome platform called Activated Bacterial Therapeutics (ABT). SB-121 is the first ever ABT to be tested in the clinic.

The Phase Ib trial is being conducted in patients diagnosed with AD between the ages of 15 and 45. The study is a multiple dose, double-blinded, placebo-controlled trial. The primary objective is to assess the safety and tolerability of SB-121. The secondary objectives include assessment of the impact of SB-121 on measures of AD.

“This study is an important milestone in our understanding of how the microbiome effects the gut-brain axis in patients with AD. It will significantly advance our efforts to potentially develop SB-121 as a therapy for patients with AD by providing critical safety data in this patient population,” said Joe Trebley, PhD, CEO of Scioto.

Scioto announced in August 2020 the raising of a Series B financing from Genome and Company (G&C). G&C (KRX: 314130) began trading on the KOSDAQ, the Korean counterpart to the US NASDAQ, in Dec 2020. G&C is one of the leading microbiome companies in the world. The clinical trial is being performed at Cincinnati Children’s Hospital Medical Center (CCHMC) in Cincinnati, OH.

“We are very excited to achieve this milestone with our partners at Scioto,” said Jisoo Pae, MD, founder and CEO of G&C. “We think SB-121 can potentially make a big impact in the lives of patients diagnosed with AD. We look forward to reviewing the data and further exploring the possibilities of SB-121 and Scioto’s ABT platform.”

“G&C has been the ideal partner in helping us take Scioto from a pre-clinical to clinical stage company. The G&C and the Scioto teams have been working collaboratively, and we are looking forward to developing SB-121 for other indications. We are off to a great start,” added Trebley.

About Scioto Biosciences

Based in Indianapolis, Scioto Biosciences is a clinical stage company developing innovative therapies devoted to having a transformative impact on the delivery of live bacterial therapeutics (LBTs). The Scioto Activated Bacterial Therapeutic (ABT) Platform has the potential to enhance efficacy wherever LBTs are used such as gastrointestinal health, diabetes, neurological disorders, alternatives to in-feed antibiotics (in livestock) and others. For more information, visit http://sciotobiosciences.com/.

About Genome & Company

Genome & Company is a publicly traded (KRX: 314130), clinical-stage biotechnology company based in Seongnam, Republic of Korea that focuses on discovering and developing the next waves of innovative therapeutics in immuno-oncology through diverse modalities of microbiome, novel target immune checkpoint inhibitors and fusion proteins to fulfill the unmet needs of cancer patients. For more information, visit http://genomecom.co.kr/

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