FDA pre-IND feedback for PT00114

AnBogen Therapeutics, Inc. (OTCQB:PTIX), a clinical-stage biopharmaceutical company, announced on August 20, 2026, that it received written responses from the U.S. United States — Food and Drug Administration (FDA) to its Type B pre-Investigational New Drug (pre-IND) meeting request for PT00114, its lead investigational neuropeptide product candidate for the treatment of generalized anxiety disorder (GAD). In its responses, FDA identified no clinical hold issues, raised no objection to the planned three-part Phase 1 program design, dose-escalation approach, and safety review governance, and indicated that the proposed potency, comparability, CMC, and nonclinical packages appear reasonable to support an IND submission. The new IND builds on PT00114's completed Phase 1 single and multiple ascending dose studies conducted outside the United States, which reported no serious adverse events. Protagenic plans to submit the IND before the end of 2026 and targets first patient dosing in the first half of 2027, pending FDA review and clearance. According to the United States — National Institute of Mental Health, GAD affects approximately 6.8 million adults in the United States annually, and no new medicine has been approved specifically for GAD in nearly two decades. Bill Nichols Jr., President of AnBogen Therapeutics, expressed confidence in the path forward, highlighting PT00114's novel mechanism targeting the brain's stress response system.