PTIX News & Events

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.

Protagenic Therapeutics announced the completion of enrollment and dosing in its Multiple Ascending Dose Phase 1 study evaluating its lead compound, known as PT00114. The study, conducted in healthy volunteers, was designed to assess the safety and tolerability profile of PT00114 following multiple doses over time. With all healthy volunteers now dosed, the company has achieved a milestone in the clinical development of its proprietary peptide-based therapeutic. The company expects to finalize and release top-line results from the MAD study by November 30.

Protagenic Therapeutics announced completion of 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, with topline safety data anticipated by the end of September, supporting advancement into Phase 2 efficacy studies planned for the first quarter of 2026. PT00114 is the first investigational therapy based on Teneurin C-terminus Associated Peptide, a naturally occurring brain hormone localized in the amygdala and hippocampus that regulates stress and emotional balance. Unlike existing therapies that blunt symptoms, PT00114 is thought to directly modulate the brain's maladaptive responses to stress-offering a differentiated approach to treating anxiety, depression, addiction, and Post Traumatic Stress Disorder. The multiple-dose study follows a 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.