Protagenic Therapeutics initiates Phase I/IIa trial for PT00114

Protagenic Therapeutics has announced the commencement of its Phase I/IIa clinical trial for PT00114, its leading drug candidate. Key Highlights: Clinical Trial Focus: The trial aims to evaluate the therapeutic potential of PT00114, a synthetic version of the naturally occurring brain peptide TCAP, in treating an array of neuro-psychiatric conditions, including depression, anxiety, and PTSD. PT00114 is a novel first in class peptide which has shown profound activity with a novel mechanism in disease models of those three conditions, as well as in treating models of addiction withdrawal. Study Design: Phase I will recruit 56 subjects, randomized to undergo subcutaneous injections of either PT00114 or a placebo. The Phase I/IIa study will assess both healthy volunteers and patients diagnosed with Treatment-Resistant Depression, PTSD, and Generalized Anxiety Disorder. Progress Indicators: Besides monitoring disease status, the trial will gauge disease response by measuring biomarkers, such as circulating cortisol levels before and after treatment. Partnership: Axiom Real-Time Metrics, a CRO/Data Analytics firm with over 1,000 clinical trials to its credit, is managing the clinical program.