On June 30, 2020 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, reported 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 (Press release, Synthetic Biologics, JUN 30, 2020, View Source [SID1234561595]). 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.
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"This IND submission is a key milestone in the clinical development program of SYN-020, which we believe can play an important role in regulating and maintaining gastrointestinal ("GI") and microbiome health," said Steven A. Shallcross, Chief Executive and Financial Officer. "We are excited about SYN-020’s potential to mitigate the intestinal damage caused by radiation therapy routinely used to treat pelvic cancers, and look forward to exploring 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 the ability 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. The Company has completed the IND-enabling nonclinical studies and early GMP manufacturing and has filed an IND application for this program.