Protagenic completes first dose escalation step in Phase I trial of PT00114

Protagenic Therapeutics announced a step forward in its mission to address stress-related neuro-psychiatric disorders. The company has completed the first dose escalation step in the Phase I safety clinical trial for PT00114, its pioneering brain peptide compound. The compound has been extensively tested in models of anxiety, depression, PTSD and addiction before entering its present clinical trial. Key Highlights: Safety Validation: PT00114 has demonstrated safety at a low dose of 125 micrograms in the initial cohort of patients, with zero reported adverse reactions among subjects. There were no injection site reactions nor any tolerability matters amongst the subjects over a 30-day observation period. Clinical Protocol Progress: This is a step in the ongoing Phase I/IIa trial, which is designed to evaluate both healthy volunteers and patients diagnosed with Treatment-Resistant Depression, PTSD, and Generalized Anxiety Disorder. The company looks forward to welcoming additional cohorts into the trial. Comprehensive Approach: In addition to monitoring disease status, the trial incorporates biomarker assessments, including circulating cortisol levels, to gauge initial treatment response. Strategic Collaboration: Axiom Real-Time Metrics, a CRO/Data Analytics firm, is partnering with Protagenic in managing the clinical program. Expert Insights: Dr. Maurizio Fava, Principal Investigator in Protagenic’s Phase I/IIa clinical trial, emphasized the urgent need for novel therapeutics in addressing stress-related disorders: “Stress-related disorders are at an all-time high, and I am excited by the possibility of a novel mechanism which may help a population of patients greatly in need of new therapeutics.”