Protagenic Therapeutics Advances Promising Candidate for Anxiety, Depression and PTSD

Protagenic Therapeutics (Nasdaq: PTIX), has successfully completed the first dose escalation step in a Phase 1 safety clinical trial for PT00114, its pioneering brain peptide compound. The company initiated its Phase I/IIa clinical trial evaluating the therapeutic potential of PT00114 in treating neuro-psychiatric conditions, including depression, anxiety, and PTSD, in September 2023.

Robert B. Stein, MD, PhD, Chief Medical Officer of Protagenic Therapeutics, commented, “Unlike benzodiazepines like Valium and Xanax, PT00114 allows appropriate responses to environmental stressors but prevents ‘deer in the headlights’ overshoot. Stress is a driver of many neuropsychiatric and neurological conditions.”

Highlights

  • Protagenic’s clinical trial is expected to recruit 56 subjects, randomized to undergo subcutaneous injections of either PT00114 or a placebo. The study will assess healthy volunteers and patients diagnosed with Treatment-Resistant Depression, PTSD, and Generalized Anxiety Disorder.
  • PT00114, a 41-amino-acid synthetic peptide, holds promise in treating various neuro-psychiatric conditions by reducing circulating cortisol levels. It has been extensively tested in models of anxiety, depression, PTSD and addiction.
  • The compound has demonstrated safety with good tolerability, no reported adverse reactions among subjects, and no injection site reactions over a 30-day observation period.
  • Protagenic is partnering with Axiom Real-Time Metrics to manage its clinical program.

About Protagenic Therapeutics

Protagenic Therapeutics, Inc. (Nasdaq: PTIX) is committed to pioneering neuro-active peptides into therapeutics to mitigate stress-related disorders. For more information, visit www.protagenic.com.

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Protagenic Therapeutics Advances Promising Candidate for Anxiety, Depression and PTSD

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