Protagenic Therapeutics Advances PT00114 into Multiple-Dose Phase 1 Trial

Protagenic Therapeutics (PTIX) has completed the first dose injection for all study subjects in the multiple-dose portion of its ongoing Phase I clinical trial of PT00114. The company expects to complete dosing by the end of August and anticipates topline safety data by the end of September, supporting advancement into Phase 2 efficacy studies planned for Q1 2026. PT00114 is an investigational therapy for stress-related and mood disorders with a favorable safety and tolerability profile.

Protagenic Therapeutics, Inc. (PTIX) has made significant progress in its clinical development program, completing the first dose injection for all study subjects in the multiple-dose portion of its ongoing Phase I clinical trial of PT00114. The company expects to complete dosing by the end of August and anticipates topline safety data by the end of September, setting the stage for Phase 2 efficacy studies planned for the first quarter of 2026.

PT00114 is an investigational therapy designed to treat stress-related and mood disorders, including anxiety, depression, addiction, and Post Traumatic Stress Disorder (PTSD). The drug operates with a novel mechanism, mimicking the active part of the natural brain hormone Teneurin C-terminus Associated Peptide (TCAP), thereby reducing circulating cortisol levels. This differentiated approach aims to address the significant unmet need in current treatments, which often fail to provide adequate relief and are burdened by significant side effects.

The multiple-dose study follows a successful single ascending dose trial that confirmed PT00114's favorable safety and tolerability profile. Data from this trial will contribute to Phase 2 studies designed to demonstrate PT00114's therapeutic potential in stress-related and mood disorders.

Protagenic Therapeutics is committed to pioneering neuro-active peptides into therapeutics to mitigate stress-related disorders. The company's progress with PT00114 marks a pivotal step in its clinical development program, positioning the drug for potential breakthroughs in the treatment of stress-related conditions.

[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.morningstar.com/news/accesswire/1063654msn/protagenic-therapeutics-advances-pt00114-into-multiple-dose-phase-1-trial-positioning-for-phase-2-in-stress-mood-disorders
[4] https://www.stocktitan.net/news/PTIX/protagenic-therapeutics-advances-pt00114-into-multiple-dose-phase-1-wg4bffevcnlj.html