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Synthetic Biologics Announces Submission Of IND Application To US FDA For SYN-020 Intestinal Alkaline Phosphatase

ROCKVILLE, Md., June 30, 2020 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE:SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat

Benzinga · -

ROCKVILLE, Md., June 30, 2020 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE: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 it submitted an Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for its SYN-020 Intestinal Alkaline Phosphatase ("IAP") program. The IND application supports an initial indication of SYN-020 for the treatment of radiation enteropathy secondary to pelvic cancer therapy. Under the IND application, the Company intends to conduct a Phase 1 single ascending dose study in healthy volunteers, designed to evaluate SYN-020 for safety, tolerability, and pharmacokinetic parameters.