NEW YORK - Protagenic Therapeutics, Inc. (NASDAQ:PTIX), a biopharmaceutical company, has announced the completion of the first dose escalation step in its Phase I clinical trial for PT00114, a novel brain peptide compound aimed at treating stress-related neuro-psychiatric disorders. The initial cohort of patients safely tolerated a low dose of 125 micrograms without any reported adverse reactions over a 30-day observation period.
The ongoing Phase I/IIa trial is designed to evaluate the safety and efficacy of PT00114 in both healthy volunteers and patients diagnosed with Treatment-Resistant Depression, PTSD, and Generalized Anxiety Disorder. The company intends to enroll additional cohorts into the trial, which also includes biomarker assessments, such as circulating cortisol levels, to gauge initial treatment response.
Axiom Real-Time Metrics, a CRO/Data Analytics firm, is collaborating with Protagenic in managing the clinical program. Dr. Maurizio Fava, the Principal Investigator in the trial, expressed optimism about the potential of PT00114 to address the urgent need for new therapeutics in the treatment of stress-related disorders.
Robert B. Stein, MD, PhD, Chief Medical Officer of Protagenic Therapeutics, described PT00114 as having a unique mechanism of action. Unlike common benzodiazepines, PT00114 allows appropriate responses to stress without the 'deer in the headlights' reaction, which can exacerbate neuropsychiatric and neurological conditions.
PT00114 is a 41-amino-acid synthetic peptide that mirrors the active part of the natural brain hormone TCAP. It is being developed as a potential treatment for a range of neuro-psychiatric conditions, including depression, anxiety, and PTSD, by reducing circulating cortisol levels.
Protagenic Therapeutics is focused on developing neuro-active peptides into therapeutics to combat stress-related disorders. The company anticipates reporting complete results from the single-dose cohort of the Phase I trial in April.
This update is based on a press release statement from Protagenic Therapeutics.
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