Northville, MI - Diapin Therapeutics, a clinical-stage biotechnology company focused on innovative treatments for cardiovascular and metabolic diseases, today announced that it has received a written response to its Pre-Investigational New Drug Application (pre-IND) questions submitted to the U.S. Food and Drug Administration (FDA) regarding the development of its lead asset, DT678, a novel prodrug designed to address limitations associated with current antiplatelet therapies. This communication provided an opportunity to receive feedback on the development strategy and regulatory pathway for DT678 in the United States. With this guidance, Diapin is actively raising a Series A as well as seeking a US/EU development partner to advance the commercialization of the product candidate.
DT678 is a clinical-stage small-molecule with patent-protected composition of matter. DT678 is a next-generation antiplatelet therapy designed to overcome the limitations of Plavix® while potentially improving upon the gold standard in antiplatelet therapy. This novel prodrug directly forms the active metabolite of clopidogrel without the need for hepatic activation. DT678 may ensure consistent efficacy across all patient populations, including poor and intermediate metabolizers with CYP2C19 mutations. These mutations affect a significant portion of the population, putting patients at increased risk of adverse cardiovascular events when treated with clopidogrel due to poor metabolism. Moreover, DT678 has demonstrated potential for a reduced bleeding risk in preclinical studies and may offer a significant advantage in antiplatelet therapy.
“The completion of the pre-IND discussion with FDA is a significant milestone for Diapin Therapeutics and we believe validates our development strategy for DT678,” said Charles Bisgaier, Ph.D., CEO of Diapin Therapeutics. “The feedback from the FDA have provided us with a potential regulatory pathway under the 505(b)(2) Hybrid New Chemical Entity (NCE) approach, which we believe may accelerate our ability to bring DT678 to market and address a critical unmet medical need in antiplatelet therapy.”
“We are excited about the potential of DT678 to revolutionize antiplatelet therapy and may provide a safer, more effective option for patients globally,” added Eugene Chen, Ph.D., M.D., Founder and Chairman of Diapin Therapeutics. “Our discussions with key opinion leaders in the cardiovascular field have reinforced the critical need for a compound like DT678, which could become a cornerstone treatment in the management of cardiovascular events and stroke.”
About Diapin Therapeutics
Diapin Therapeutics is a clinical-stage biotechnology company developing novel treatments for cardiovascular and metabolic diseases. In addition to Diapin’s lead asset, DT678, our pipeline also includes DT109, a tripeptide targeting multiple high-value potential indications including Metabolic Steatohepatitis (MASH), Primary Biliary Cholangitis, Type II Diabetes, Familial Partial Lipodystrophy, and Cardiovascular Disease.
For more information, please visit https://diapin.com
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect the Company’s current expectations and assumptions regarding future events, which are subject to risks and uncertainties. Actual results could differ materially from those anticipated due to various factors. The Company undertakes no obligation to update these statements, except as required by law.
Contact Information
Charles Bisgaier, Ph.D.
