![]() Both Phase 1 SAD and MAD studies are intended to support the development of SYN-020 in multiple potential clinical indications, including celiac disease, nonalcoholic fatty liver disease (NAFLD), radiation enteropathy, and indications to treat and prevent metabolic and inflammatory disorders associated with aging, which are supported by the Company's collaboration with Massachusetts General Hospital. Topline results from this clinical trial are anticipated during the second quarter of 2022. No serious adverse events were reported.Ī second Phase 1 clinical trial intended to evaluate the safety, tolerability and biodistribution of multiple-ascending doses (MAD) of SYN-020 in healthy volunteers is expected to commence during the third quarter of 2021. Analyses of preliminary data demonstrated that SYN-020 maintained a favorable safety profile, was well tolerated at all dose levels, and no adverse events were attributed to the study drug. The Phase 1 SAD study enrolled 24 healthy adult volunteers into four cohorts with SYN-020 given orally as single doses ranging from 5 mg to 150 mg daily. ROCKVILLE, Md., J/PRNewswire/ - Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, today announced that patient dosing and observation has been completed in its Phase 1, open label, single-ascending dose (SAD) clinical trial of SYN-020 intestinal alkaline phosphatase (IAP).
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