Synthetic Biologics Inc. (NASDAQ: SYN) stock declined by 5% at last close while the SYN stock price surged by 2.58% in the pre-market trading session. Synthetic Biologics is a clinical-stage business that uses the microbiome to create medicines to prevent and cure GI illnesses in regions where there is a significant unmet need.
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What is happening?
Synthetic Biologics revealed that Patient dosing and monitoring in SYN’ Phase 1 open-label, single-ascending dose (SAD) clinical study of SYN-020 intestinal alkaline phosphatase has been finished (IAP). SYN-020 was administered orally in single dosages ranging from 5 mg to 150 mg daily to 24 healthy adult volunteers in Phase 1 SAD trial. SYN-020 had a positive safety profile, was well accepted at all dosage levels, and no adverse events were linked to the study medication, according to early data. There were no significant side effects recorded.
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During the third quarter of 2021, a second Phase 1 clinical trial to assess the efficacy, acceptability, and biodistribution of multiple-ascending doses of SYN-020 in healthy volunteers is planned to begin. The clinical trial’s topline results are expected in the second quarter of 2022. SYN-020 is being developed in many possible therapeutic indications, including celiac disease, nonalcoholic fatty liver disease, and radiation enteropathy, in both Phase 1 SAD and MAD trials. Also, indications for treating and preventing metabolic and inflammatory diseases linked to aging, which are backed up by SYN’s partnership with Massachusetts General Hospital.
Steven A. Shallcross, CEO of Synthetic Biologics stated,
SYN-020 is an enticing, versatile program with the capability to become a multi-indication, platform therapeutic that can tackle a significant unmet need for innovative new therapies targeting gastrointestinal inflammation-related disorders, such as celiac disease, NAFLD, and age-related metabolic and inflammatory diseases. By 2023, the number of cases of celiac disease in the United States is anticipated to reach 4.3 million, offering a huge market potential for a highly differentiated product like SYN-020. SYN is delighted by the promising Phase 1 results and looks forward to continuing development of SYN-020, which will involve the start of a second Phase 1, multiple-ascending dosage trial in the third quarter of 2021.