Protagenic Therapeutics Reports Safety Results of PT00114 Phase 1 Study

Written by Emily J. Thompson, Senior Investment Analyst

Updated: Dec 09 2025

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Protagenic Therapeutics reported topline safety results from its Phase 1 Multiple Dose 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. 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. Protagenic Therapeutics is finalizing its detailed analysis of the full Phase 1 dataset, including pharmacokinetic modeling to support dose selection. A comprehensive report will be released once analyses are complete. The company expects to initiate a Phase 2 study in early 2026 to evaluate PT00114 in a targeted patient population affected by chronic stress-related psychiatric disorders. Additional details on study design and endpoints will be communicated in the coming months.

PTIX

$0.4255+Infinity%1D

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About PTIX

Protagenic Therapeutics, Inc. is a neuroactive biopharmaceutical company. The Company has approximately six drug candidates targeting stress-related and CNS disorders, including treatments for obesity and metabolic disorders. The Company's pipeline includes PT-00114 in Phase I/IIa and five preclinical assets including PHYX-001, cannabinoid-based compounds, and modified stilbenoid assets. The PHYX-001 is a potassium channel modulator with a mechanism similar to XEN1101 and BHV-7000. The Company's cannabinoid assets include multiple cannabinoid-based compounds with composition-of-matter IP; potential in CNS, cardiometabolic, and other indications. The Company's cannabinoid assets also include a molecule with potential in the obesity, metabolic dysfunction sector, where the GLP-1 agonists have become medications. Its modified stilbenoid assets include modified stilbenoid compounds with composition-of-matter IP and anticonvulsant activity in preclinical models.

About the author

Emily J. Thompson

Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.