Protagenic Therapeutics, Inc. advanced its mission to develop cutting-edge treatments for stress-related neuropsychiatric disorders. The company has reached another milestone by completing three out of five cohorts of healthy volunteers with PT00114, its synthetic version of the stress-regulating peptide TCAP, in a SAD Phase 1 clinical trial. Notably, PT00114 has shown excellent tolerability with no adverse safety findings during these ongoing Phase 1 studies.

With promising preclinical efficacy in anxiety, depression, PTSD, and addiction models, PT00114 moves forward in clinical evaluation, representing a step toward potentially transformative therapies. Key Highlights: Safety Validation: Building on the low dose safety validation announced February 13th, PT00114 has now demonstrated safety at a medium dose of 500 micrograms administered subcutaneously in the third of five planned cohorts of subjects in the single dose portion of the Phase I trial. No adverse reactions were observed among subjects, consistent with the two lower dose cohorts (125 micrograms and 250 micrograms), with no reported injection site reactions or tolerability issues in the week following dosing.

Based on preclinical pharmacology, PT00114 is expected to be administered once weekly via subcutaneous injection. Clinical Protocol Progress: This marks progress in the ongoing Phase 1/2a trial, designed to assess both healthy volunteers and patients diagnosed with Treatment-Resistant Depression, PTSD, or Generalized Anxiety Disorder. The company plans to enroll the final two cohorts into the single dose portion of the Phase 1 trial within the next month.

Comprehensive Approach: In addition to monitoring disease status, the trial incorporates biomarker assessments, including circulating cortisol levels, to measure initial treatment response. Dr. Maurizio Fava, Psychiatrist-in-Chief at Massachusetts General Hospital, serves as the Principal Investigator in Protagenic's Phase 1/2a clinical trial with a basket design. Strategic Collaboration: Axiom Real-Time Metrics, a CRO/Data Analytics firm, manages the clinical program.