Protagenic Therapeutics Advances Novel TCAP-Based Therapy PT00114 into Multiple-Dose Phase 1 Trial for Stress-Related Disorders
Key Insights
Protagenic Therapeutics (search) has completed first dose injections for all subjects in the multiple-dose portion of its Phase 1 trial for PT00114, with dosing completion expected by end of August 2025.
PT00114 represents the first investigational therapy based on Teneurin C-terminus Associated Peptide (search) (TCAP (search)), a naturally occurring brain hormone that regulates stress and emotional balance in the amygdala and hippocampus.
The company plans to advance into Phase 2 efficacy studies in the first quarter of 2026, targeting anxiety (search), depression (search), addiction (search), and PTSD (search) with a novel mechanism that directly modulates maladaptive stress responses.
Protagenic Therapeutics (search), Inc. (NASDAQ:PTIX) announced completion of first dose injections for all study subjects in the multiple-dose portion of its ongoing Phase 1 clinical trial of PT00114, marking a significant milestone in the development of the first investigational therapy based on Teneurin C-terminus Associated Peptide (search) (TCAP (search)). The company expects to complete dosing by the end of August 2025, with topline safety data anticipated by the end of September, supporting advancement into Phase 2 efficacy studies planned for the first quarter of 2026.
Novel Mechanism Targets Brain's Stress Response
PT00114 represents a differentiated approach to treating stress-related neuropsychiatric conditions through its unique mechanism of action. The therapy is based on TCAP (search), 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 potential treatment for anxiety (search), depression (search), addiction (search), and Post Traumatic Stress Disorder (search) (PTSD (search)).
The 41-amino-acid synthetic peptide operates by mirroring the active part of the natural brain hormone TCAP (search), thereby reducing circulating cortisol levels. This novel mechanism addresses a significant unmet medical need, as current treatments leave more than half of patients without adequate relief and are burdened by significant side effects.
Clinical Development Progress
"Initiating the multiple-dose trial of PT00114 marks a pivotal step in our clinical program," said Robert Stein, M.D., Ph.D., Chief Medical Officer. "With dosing on track to complete this month, we are preparing to transition rapidly into Phase 2 efficacy trials."
The multiple-dose study follows a successful single ascending dose trial that confirmed PT00114's favorable safety and tolerability profile. Data from the current trial will contribute to Phase 2 studies designed to demonstrate PT00114's therapeutic potential in stress-related and mood disorders.
Addressing Unmet Medical Need
The development of PT00114 addresses a critical gap in neuropsychiatric treatment options. Current therapeutic approaches for anxiety (search), depression (search), addiction (search), and PTSD (search) often provide inadequate relief for a substantial portion of patients while causing significant adverse effects. PT00114's mechanism of directly targeting the brain's stress response system through TCAP (search) modulation represents a potentially transformative approach to treating these conditions.
Protagenic Therapeutics (search) is committed to pioneering neuro-active peptides into therapeutics to mitigate stress-related disorders, with PT00114 serving as the lead candidate in this innovative therapeutic approach.