Synthetic Biologics Announces FDA Clearance of Investigational New Drug Application for SYN-020 Intestinal Alkaline Phosphatase (IAP)
-- Phase 1 Single Ascending Dose Study is Intended to Support the Clinical Development of SYN-020 in Multiple Indications --
ROCKVILLE, Md., July 30, 2020 /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 it has received a study-may-proceed letter from the U.S. Food and Drug Administration (FDA) for the first clinical study of SYN-020, an oral formulation of recombinant intestinal alkaline phosphatase.
Synthetic Biologics intends to conduct a Phase 1 single ascending dose study in healthy volunteers, designed to evaluate SYN-020 for safety, tolerability, and pharmacokinetic parameters, during the first quarter of 2021. The Phase 1 clinical program is intended to support the clinical development of SYN-020 in multiple indications, including for the treatment of radiation enteropathy secondary to pelvic cancer therapy.
"Receipt of the study-may-proceed letter from the FDA is a significant milestone for our SYN-020 program, which we believe will demonstrate an important role in regulating and maintaining GI and microbiome health," said Steven A. Shallcross, Chief Executive and Financial Officer. "We are excited to begin a clinical development program with an initial indication intended to evaluate SYN-020's ability to mitigate the intestinal damage caused by radiation therapy routinely used to treat pelvic cancers. Looking ahead, we will continue to explore additional indications where the use of orally administered IAP may have a profound impact on treating and preventing age-related metabolic and inflammatory diseases."
Synthetic Biologics previously announced an agreement with Massachusetts General Hospital (MGH) granting the Company an option for an exclusive worldwide license to intellectual property and technology related to the use of IAP to maintain GI and microbiome health, diminish systemic inflammation, and treat age-related diseases. If executed, the Company plans to use this license in the advancement of an expanded clinical development program for SYN-020.
About SYN-020 Intestinal Alkaline Phosphatase (IAP)
SYN-020 is a purified recombinant bovine IAP formulated for oral delivery to the intestines. The published literature indicates that IAP functions to diminish intestinal inflammation, tighten the gut barrier to diminish "leaky gut," and promote a healthy microbiome. Despite its broad therapeutic potential, a key hurdle to commercialization has been the high cost of IAP manufacture. Synthetic Biologics has overcome this hurdle and has been able to produce SYN-020 at a scale and cost viable for clinical and commercial development. Synthetic Biologics is currently developing SYN-020 to reduce acute intestinal side effects associated with radiation therapy in patients with pelvic cancers