Protagenic Therapeutics Inc. has announced positive topline safety results from its Phase 1 Multiple Dose study of PT00114, a synthetic analogue of a naturally occurring brain peptide aimed at treating stress-related neuropsychiatric conditions. The Phase 1 study, conducted in healthy volunteers, evaluated the safety, tolerability, and pharmacokinetic profile of PT00114 across multiple dose levels. No serious adverse events were observed, and reported adverse events were consistent with expectations for a peptide-based injectable therapy, including expected injection-site reactions. All participants completed the assigned dosing schedules. Protagenic Therapeutics is finalizing a comprehensive analysis of the Phase 1 dataset and plans to initiate a Phase 2 study in early 2026 to further evaluate PT00114 in patients with chronic stress-related psychiatric disorders. Detailed results and study design information for the next phase will be communicated in the coming months.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Protagenic Therapeutics Inc. published the original content used to generate this news brief via ACCESS Newswire (Ref. ID: 1115788) on December 09, 2025, and is solely responsible for the information contained therein.
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