Protagenic Therapeutics Achieves First Clinical Safety Milestone with its Novel Neuropeptide for the Potential Treatment of Stress-Related Disorders

Company Anticipates Reporting Complete Phase I Single Dose Results in April

NEW YORK, NY / ACCESSWIRE / February 13, 2024 / Protagenic Therapeutics, Inc. (NASDAQ:PTIX), a biopharmaceutical innovator, announced a step forward in its mission to address stress-related neuro-psychiatric disorders. The company has completed the first dose escalation step in the Phase I safety clinical trial for PT00114, its pioneering brain peptide compound. The compound has been extensively tested in models of anxiety, depression, PTSD and addiction before entering its present clinical trial.

Key Highlights:

• Safety Validation: PT00114 has demonstrated safety at a low dose of 125 micrograms in the initial cohort of patients, with zero reported adverse reactions among subjects. There were no injection site reactions nor any tolerability matters amongst the subjects over a 30-day observation period.
• Clinical Protocol Progress: This is a step in the ongoing Phase I/IIa trial, which is designed to evaluate both healthy volunteers and patients diagnosed with Treatment-Resistant Depression, PTSD, and Generalized Anxiety Disorder. The company looks forward to welcoming additional cohorts into the trial.
• Comprehensive Approach: In addition to monitoring disease status, the trial incorporates biomarker assessments, including circulating cortisol levels, to gauge initial treatment response.
• Strategic Collaboration: Axiom Real-Time Metrics, a CRO/Data Analytics firm, is partnering with Protagenic in managing the clinical program.
• Expert Insights: Dr. Maurizio Fava, Principal Investigator in Protagenic's Phase I/IIa clinical trial, emphasized the urgent need for novel therapeutics in addressing stress-related disorders: "Stress-related disorders are at an all-time high, and I am excited by the possibility of a novel mechanism which may help a population of patients greatly in need of new therapeutics."

Company Perspective:

Robert B. Stein, MD, PhD, Chief Medical Officer of Protagenic Therapeutics, highlighted the distinctive mechanism of PT00114: "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."

About Protagenic Therapeutics, Inc.:

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.

About PT00114:

PT00114, a 41-amino-acid synthetic peptide, holds promise in treating various neuro-psychiatric conditions, including depression, anxiety, and PTSD. It operates with a novel mechanism, mirroring the active part of the natural brain hormone TCAP, thereby reducing circulating cortisol levels.

Forward-Looking Statements:

This press release contains forward-looking statements concerning Protagenic Therapeutics' product candidates and clinical trial plans. These statements are subject to various risks and uncertainties. Investors are urged to exercise caution and not place undue reliance on these forward-looking statements.

Company Contact:

Alexander K. Arrow, MD, CFA
 Chief Financial Officer 
Protagenic Therapeutics, Inc. 149 Fifth Ave, Suite 500, New York, NY 10010. Tel: 213-260-4342 
Email: alex.arrow@protagenic.com

Investor Relations Contact:

Kirin M. Smith, President, PCG Advisory, Inc. 950 Third Avenue, Suite #2700, New York, NY 10022. Tel: 646-823-8656 Email: ksmith@pcgadvisory.com

SOURCE: Protagenic Therapeutics, Inc.