Protagenic Therapeutics gets FDA pre-IND feedback with no objections for PT00114 GAD Phase 1 plan

Protagenic Therapeutics, Inc.new

FDA identified no clinical hold issues and raised no objection to the three-part Phase 1 design, dose-escalation, and safety review governance.
FDA deemed the potency/comparability strategy, CMC, and nonclinical packages reasonable to support an IND submission.
Company plans to submit the IND before end of 2026 (Q4 2026); targets first patient dosing in first half of 2027.
PT00114 completed ex-US Phase 1 single- and multiple-ascending-dose studies, well tolerated with no serious adverse events.
GAD affects ~6.8M U.S. adults; no new medicine approved specifically for GAD in nearly two decades.

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