Protagenic Therapeutics Advances PT00114 into Multiple-Dose Phase 1 Trial; Phase 2 for Stress & Mood Disorders Set for 1Q 2026
Protagenic Therapeutics Inc. has announced the advancement of its investigational therapy, PT00114, into a multiple-dose Phase 1 clinical trial. The biopharmaceutical company, known for developing novel neuro-active peptide therapies, expects to complete dosing by the end of August 2025. Topline safety data is anticipated by the end of September 2025, which will support the transition into Phase 2 efficacy studies scheduled for the first quarter of 2026. PT00114, based on Teneurin C-terminus Associated Peptide $(TCAP)$, aims to modulate the brain's responses to stress, offering a new approach to treating stress-related and mood disorders such as anxiety, depression, addiction, and PTSD. Results from the multiple-dose Phase 1 trial have not yet been presented.
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