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Protagenic Therapeutics, Inc.
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News: PTIX
Protagenic Therapeutics Receives FDA Pre-IND Feedback Supporting New IND for PT00114 in Generalized Anxiety Disorder
FDA raises no objection to the Company's planned Phase 1 program design, dose-escalation approach, or CMC and nonclinical packages; IND submission remains on track for the fourth quarter of 2026 NEW YORK, NY / ACCESS Newswire / August 20, 2026 / Protagenic Therapeutics, Inc. (OTCQB:PTIX), a clinical-stage biopharmaceutical company developing novel peptide-based treatments for stress-related neuropsychiatric disorders, today announced that it has received written responses from the U.S. Food and Drug Administration (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). In its written responses, FDA identified no clinical hold issues and raised no objection to the overall design of the Company's planned three-part Phase 1 program, including its dose-escalation approach and safety review governance, and did not identify deficiencies that it indicated would preclude submission of an IND.
Protagenic Therapeutics' Lead Candidate PT00114 Attenuated Chronic Stress Responses in a Well-Established Rodent Model
As published in Behavioural Pharmacology, two days of PT00114 treatment reduced corticosterone levels and attenuated anxiety-like behavior in chronically stressed rats; a known CRF₁ receptor antagonist did not show activity in the same model. NEW YORK, NY / ACCESS Newswire / June 30, 2026 / Protagenic Therapeutics, Inc. (OTCQB:PTIX), a clinical-stage biopharmaceutical company focused on novel neuropeptide therapies for stress-related disorders, today announced the publication of new preclinical data for its lead candidate, PT00114, in the peer-reviewed journal Behavioural Pharmacology.
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