Protagenic Therapeutics Shares Surge on Clinical Trial Progress: PT00114 Shows Promise in Treating Stress and Mood Disorders

Protagenic Therapeutics (PTIX) shares surged over 100% after the company announced successful administration of the first dose to all subjects in its ongoing Phase 1 clinical trial for PT00114, a hormone therapy for stress and mood disorders. The company expects to complete dosing by the end of August and release topline safety data by September.

Protagenic Therapeutics (PTIX) shares surged over 100% on Monday, July 2, 2025, following the company's announcement that it successfully administered the first dose to all subjects in its ongoing Phase 1 clinical trial for PT00114, a hormone therapy for stress and mood disorders. The company expects to complete dosing by the end of August and release topline safety data by September.

PT00114 is an investigational therapy based on Teneurin C-terminus Associated Peptide (TCAP), a natural brain hormone that regulates stress and emotional balance. Unlike existing treatments, PT00114 is designed to modulate maladaptive stress responses directly within the amygdala and hippocampus, offering a differentiated approach to treating conditions such as anxiety, depression, addiction, and Post Traumatic Stress Disorder (PTSD).

The multiple-dose Phase 1 trial follows a successful single ascending dose trial that confirmed PT00114's favorable safety and tolerability profile. The company expects to transition rapidly into Phase 2 efficacy trials in the first quarter of 2026, based on the topline safety data anticipated by the end of September.

Protagenic Therapeutics, Inc. is committed to pioneering neuro-active peptides into therapeutics to mitigate stress-related disorders. PT00114, a synthetic 41-amino-acid peptide, mimics the active part of the natural TCAP hormone, potentially reducing circulating cortisol levels and providing a novel treatment pathway for mood disorders.

The stock's meteoric rise—trading at a 111.84% intraday gain—reflects investor optimism over the drug’s potential to disrupt the $15B anxiety and depression market. With dosing completion expected by August 31 and Phase 2 trials slated for Q1 2026, the biotech’s TCAP-based therapy is now a focal point for capital inflows and speculative bets.

References:
[1] https://finance.yahoo.com/news/protagenic-therapeutics-advances-pt00114-multiple-121200453.html
[2] https://www.gurufocus.com/news/3073036/protagenic-therapeutics-advances-pt00114-into-multipledose-phase-1-trial-positioning-for-phase-2-in-stress-mood-disorders-ptix-stock-news
[3] https://www.ainvest.com/news/protagenic-soars-111-phase-1-trial-progress-biotech-breakout-sustain-momentum-2508/