Clinical Read2026-06-30

PT00114

Protagenic Therapeutics Inc.PTIX
Indication
Major Depressive Disorder (MDD) / Generalized Anxiety Disorder (GAD) / Post-Traumatic Stress Disorder (PTSD)
Stage
phase0
Event
Topline Data
Details

June 30, 2026: Protagenic Therapeutics, Inc. (OTCQB: PTIX) announced publication in Behavioural Pharmacology of new preclinical data on lead candidate PT00114 (a synthetic analog of TCAP-1) in a chronic unpredictable stress rat model. In male Sprague Dawley rats exposed to a 14-day stress paradigm, two subcutaneous doses of PT00114 (250 nmol/kg on days 12 and 13) reduced stress-induced plasma corticosterone by 56.4% versus stressed saline controls (p=0.029) and increased time spent in the center of an open-field arena by 282% (p=0.031), with no significant change in total distance traveled (suggesting the anxiolytic-like effect was not due to altered locomotion). In the same model, the CRF₁ receptor antagonist comparator CP-154,526 showed no effect on corticosterone or open-field center time when dosed on days 12/13 or continuously throughout the paradigm. The company cited the findings as supporting PT00114’s development for chronic stress-related conditions; it reported positive topline Phase 1 safety results previously and plans to initiate subsequent clinical studies in 2027.