Protagenic Therapeutics Initiates Phase I/IIa Clinical Trial for Groundbreaking Brain Peptide PT00114

A potential major step toward treating stress-related neuro-psychiatric disorders

NEW YORK, NY / ACCESSWIRE / September 26, 2023 / Today, Protagenic Therapeutics, Inc. (NASDAQ:PTIX), a pioneering biopharmaceutical company, has announced the commencement of its Phase I/IIa clinical trial for PT00114, its leading drug candidate.

Key Highlights:

• Clinical Trial Focus: The trial aims to evaluate the therapeutic potential of PT00114, a synthetic version of the naturally occurring brain peptide TCAP, in treating an array of neuro-psychiatric conditions, including depression, anxiety, and PTSD. PT00114 is a novel first in class peptide which has shown profound activity with a novel mechanism in disease models of those three conditions, as well as in treating models of addiction withdrawal.
• Study Design: Phase I will recruit 56 subjects, randomized to undergo subcutaneous injections of either PT00114 or a placebo. The Phase I/IIa study will assess both healthy volunteers and patients diagnosed with Treatment-Resistant Depression, PTSD, and Generalized Anxiety Disorder.
• Progress Indicators: Besides monitoring disease status, the trial will gauge disease response by measuring biomarkers, such as circulating cortisol levels before and after treatment.
• Partnership: Axiom Real-Time Metrics, a CRO/Data Analytics firm with over 1,000 clinical trials to its credit, is managing the clinical program.

Expert Insights:
Dr. Maurizio Fava, Psychiatrist-in-Chief in the Department of Psychiatry at Massachusetts General Hospital (MGH), Associate Dean for Clinical & Translational Research, Slater Family Professor of Psychiatry at Harvard Medical School, and an international leader in depression, who is serving as principal investigator in Protagenic's Phase I/IIa clinical trial, commented, "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 Focus:
Robert B. Stein, MD, PhD, Chief Medical Officer of Protagenic Therapeutics, remarked, "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. The pre-clinical pharmacology of PT00114 has been extremely promising."

About Protagenic Therapeutics, Inc. A clinical-stage biopharmaceutical trailblazer, Protagenic Therapeutics, Inc. (Nasdaq: PTIX), is dedicated to developing neuro-active peptides into therapeutics to mitigate stress-related disorders. Learn more at www.protagenic.com.

About PT0014 PT00114, a 41-amino-acid synthetic peptide, mirrors the active part of the natural brain hormone TCAP. This peptide has a pivotal role in the human body's biochemical stress-reduction process by curbing circulating cortisol. Promising results have been noted in animal models against prominent human stress-induced disorders.

Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding Protagenic Therapeutics' product candidates and pre-clinical development and clinical trial plans and activities. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, our ability to obtain additional capital which will be necessary to complete the clinical trials described above; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors described under the Risk Factors section of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission. Investors are urged to exercise caution and not place undue reliance on these forward-looking statements, which are current as of this press release date.. These statements speak only as of the date of this press release, and Protagenic undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

Press Contact:
Alexander K. Arrow, MD, CFA Chief Financial Officer Protagenic Therapeutics, Inc. Tel: 213-260-4342 Email: alex.arrow@protagenic.com

SOURCE: Protagenic Therapeutics, Inc.