Protagenic Therapeutics Achieves First Clinical Safety Milestone with its Novel Neuropeptide for the Potential Treatment of Stress-Related Disorders
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The completion of the first dose escalation in a Phase I clinical trial marks a significant milestone for Protagenic Therapeutics in their development of PT00114. This compound's targeting of stress-related neuro-psychiatric disorders, including anxiety, depression, PTSD and addiction, addresses a substantial market need given the rising prevalence of these conditions.
Crucially, the reported safety of PT00114 at an initial low dose without adverse reactions provides a positive signal for future trial phases. The absence of adverse effects, particularly in a domain where medications often come with significant side effects, is noteworthy. The compound's unique mechanism, which allows for appropriate stress responses without the 'deer in the headlights' effect, could represent a significant advancement over current treatments like benzodiazepines, which are known for their sedative effects and potential for dependency.
From a financial perspective, the advancement of PT00114 through Phase I trials is likely to be viewed favorably by investors, as early-phase clinical success reduces the binary risk associated with drug development. The strategic collaboration with Axiom Real-Time Metrics could also streamline the clinical process, potentially reducing costs and time to market.
Investors should note the compound's potential to capture market share from existing treatments, given its novel mechanism of action. However, they must also be aware of the long road ahead before commercialization, including further safety and efficacy trials, regulatory approval and the challenges of market penetration amidst established competitors.
PT00114's progress to the next stage of clinical trials is indicative of its potential as a therapeutic agent. The focus on biomarker assessments, such as circulating cortisol levels, suggests a comprehensive approach to validating the drug's efficacy. This could be pivotal in demonstrating the compound's mechanism of action and its direct impact on stress biomarkers, which is critical for gaining regulatory approval and clinician acceptance.
The compound's distinction from benzodiazepines is of particular interest, as it suggests a potential for PT00114 to be used without the common drawbacks of sedation and dependency. This could lead to a paradigm shift in the treatment of stress-related disorders if the clinical outcomes support these early findings.
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.
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