Pharma Pioneer

Protagenic Therapeutics Hits Safety Milestone in Phase I Trial for Stress-Related Disorders Treatment

29 May 2024
2 min read

Protagenic Therapeutics, Inc., a biopharmaceutical company listed on NASDAQ (PTIX), has made progress in its clinical trial for a new brain peptide compound called PT00114. This compound is being developed to treat stress-related neuro-psychiatric disorders such as anxiety, depression, PTSD, and addiction. The company has successfully completed the first step in the Phase I trial, which involved a single dose of PT00114 at 125 micrograms. The initial group of patients showed no adverse effects from the treatment over a 30-day period, indicating the compound's safety.
The ongoing Phase I/IIa trial is designed to assess both healthy individuals and those with Treatment-Resistant Depression, PTSD, and Generalized Anxiety Disorder. The trial also includes biomarker assessments to evaluate the initial response to the treatment. Protagenic is collaborating with Axiom Real-Time Metrics, a firm specializing in clinical research and data analytics, to manage the trial.
Dr. Maurizio Fava, the lead investigator for the trial, has expressed the importance of developing new therapies for stress-related disorders, which are becoming increasingly prevalent. PT00114 is unique in that it allows for a normal response to stress without causing an excessive reaction, unlike benzodiazepines such as Valium and Xanax.
Robert B. Stein, MD, PhD, the Chief Medical Officer of Protagenic, has noted that PT00114 works by mimicking a part of the natural brain hormone TCAP, which helps in reducing cortisol levels in the body. The company anticipates releasing the full results of the Phase I single dose in April.
PT00114 is a synthetic peptide consisting of 41 amino acids and is expected to be effective in treating a range of neuro-psychiatric conditions. The company's commitment to developing neuro-active peptides as therapeutics is aimed at mitigating the impact of stress-related disorders.

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