Protagenic Therapeutics (OTCQB: PTIX) has announced that it has received written responses from the FDA to its Type B pre-Investigational New Drug (pre-IND) meeting request for PT00114, the company’s leading investigational neuropeptide product candidate, for the treatment of generalized anxiety disorder (GAD).
According to Protagenic, the new IND builds directly on PT00114’s completed Phase 1 single ascending dose and multiple ascending dose studies, which were conducted outside the U.S. In those studies, PT00114 was reported to be well tolerated across all dose levels studied, with no serious adverse events reported.
In a statement, Bill Nichols Jr., president of Protagenic, commented, “FDA’s feedback gives us a clear path to submitting a new IND for PT00114 in generalized anxiety disorder, and it reflects the clinical and manufacturing groundwork our team has completed to date. In preclinical studies, PT00114 has been observed to act directly on the brain’s stress response system rather than simply blunting symptoms, and we believe that mechanism, if confirmed in clinical trials, could represent a meaningfully different approach for a patient population this large and this underserved. Submitting this IND is our next milestone, and we look forward to continuing to work with FDA.”
