Protagenic Therapeutics Completes First Step of Phase I Clinical Trial for PT00114, a Promising Compound for Treating Stress-related Neuro-psychiatric Disorders
Protagenic Therapeutics, Inc. (PTIX), a prominent biopharmaceutical company, has successfully reached a significant milestone in its Phase I clinical trial for PT00114, a groundbreaking brain peptide compound aimed at addressing stress-related neuro-psychiatric disorders. The initial group of patients demonstrated excellent tolerance to a low dose of 125 micrograms, with no reported adverse reactions over a 30-day observation period.
This ongoing Phase I/IIa trial, which is designed to assess the safety and efficacy of PT00114, will include both healthy volunteers and patients diagnosed with Treatment-Resistant Depression, PTSD, and Generalized Anxiety Disorder. Protagenic Therapeutics plans to enroll additional study groups, while also incorporating biomarker assessments, such as circulating cortisol levels, to evaluate the initial treatment response. To manage the clinical program, the company is partnering with Axiom Real-Time Metrics, a leading CRO/Data Analytics firm.
Dr. Maurizio Fava, the Principal Investigator in the trial, expressed optimism about the potential of PT00114 to meet the urgent need for new therapeutics in the treatment of stress-related disorders. With a unique mechanism of action, PT00114 distinguishes itself from common benzodiazepines by allowing appropriate stress responses without exacerbating neuropsychiatric and neurological conditions, which often result in the “deer in the headlights” reaction.
PT00114, a synthetic peptide consisting of 41 amino acids, mimics the active part of the natural brain hormone TCAP. Its development aims to address various neuro-psychiatric conditions, including depression, anxiety, and PTSD, by reducing circulating cortisol levels. Protagenic Therapeutics remains committed to leveraging neuro-active peptides to develop effective therapeutics for stress-related disorders.
The company aims to release complete results from the single-dose cohort of the Phase I trial in April, further shedding light on the potential of PT00114 as a game-changing treatment option.
Analyst comment
Positive news.
As an analyst, it is expected that the positive results from the Phase I clinical trial for PT00114 will lead to increased investor confidence and interest in Protagenic Therapeutics. The company’s partnership with Axiom Real-Time Metrics will provide strong support for the management of the clinical program. If the subsequent study groups and biomarker assessments continue to show positive results, it is likely that Protagenic Therapeutics will experience growth in the market as PT00114 becomes a potential game-changing treatment option for stress-related neuro-psychiatric disorders.
