Protagenic Therapeutics Reports Topline Phase 1 Safety Data For PT00114, Was Well Tolerated Across All Dose Ranges Studied; Paves Way For Phase 2 In Stress-Related Neuropsychiatric Conditions

Findings support advancement into Phase 2 to explore a first-in-class pathway aimed at stress-related neuropsychiatric conditions

NEW YORK CITY, NEW YORK / ACCESS Newswire / December 9, 2025 / Protagenic Therapeutics Inc. (NASDAQ:PTIX), a biopharmaceutical company developing therapeutics that target the biology of chronic stress and its downstream psychiatric and neurologic effects, today reported positive topline safety results from its Phase 1 Multiple Dose (MD) study of PT00114.

PT00114 is a synthetic analogue of a naturally occurring brain peptide thought to be involved in restoring homeostasis following prolonged exposure to stress. Its mechanism of action-rooted in rebalancing dysfunctional stress-response circuits-represents a departure from conventional neurotransmitter-focused approaches and may offer a new pathway for patients whose conditions remain insufficiently treated with existing therapies.

Phase 1 MD Study Overview

The study was conducted in healthy volunteers and was designed to evaluate the safety, tolerability, and pharmacokinetic profile of PT00114 across multiple dose levels. All planned cohorts have completed dosing.

Preliminary analyses show:

PT00114 was well tolerated across all dose ranges studied.

Reported adverse events were consistent with expectations for a peptide-based injectable therapy, including expected injection-site reactions.

No serious adverse events were observed, and all participants completed the assigned dosing schedules.