Protagenic Therapeutics Successfully Concludes Third Cohort in Single Dose Portion of Phase 1 Trial for Stress-Related Neuropsychiatric Disorders
- PTIX completes three out of five cohorts of healthy volunteers with PT00114 in a SAD Phase 1 clinical trial.
- PT00114 shows excellent tolerability with no adverse safety findings in ongoing Phase 1 studies.
- PT00114 demonstrates safety at a medium dose of 500 micrograms in the third cohort of subjects, with no adverse reactions reported.
- The ongoing Phase 1/2a trial includes healthy volunteers and patients with Treatment-Resistant Depression, PTSD, or Generalized Anxiety Disorder.
- The trial incorporates biomarker assessments, including circulating cortisol levels, to measure initial treatment response.
- Dr. Maurizio Fava from Massachusetts General Hospital leads Protagenic's Phase 1/2a clinical trial with a basket design.
- Axiom Real-Time Metrics manages the clinical program as a CRO/Data Analytics firm.
- None.
Insights
The advancement of Protagenic Therapeutics' PT00114 through its Phase 1 clinical trial is noteworthy for stakeholders due to the compound's potential to address a range of stress-related neuropsychiatric disorders. The successful completion of three cohorts without adverse safety findings underpins the drug's safety profile at increasing dosages. This is a significant step in drug development, as safety and tolerability are critical factors that can influence the progression to later-stage trials and ultimately impact a drug's commercial viability.
Furthermore, the strategic collaboration with Axiom Real-Time Metrics indicates a thorough and data-driven approach to managing the clinical program. This partnership may enhance the efficiency and reliability of the trial outcomes, which is essential for investor confidence. The integration of biomarker assessments, such as cortisol levels, provides a quantitative measure of the drug's impact, which could be a differentiator if the results are positive. It's important for investors to monitor these developments, as successful clinical trial outcomes can lead to significant stock appreciation, particularly for biopharmaceutical companies with novel therapies in development.
The progress of PT00114 in clinical trials is a critical factor for Protagenic Therapeutics' financial outlook. The transition from preclinical to clinical efficacy is a leap that often leads to a revaluation of a biotech company's stock. Given the broad application potential for stress-related conditions such as anxiety, depression, PTSD and addiction, the addressable market for PT00114 could be substantial. However, it's essential to consider that the drug is still in early-stage development and the path to market approval is long and fraught with risks.
Investors should also note that the company's approach to enrolling patients with Treatment-Resistant Depression, PTSD, or Generalized Anxiety Disorder in the Phase 1/2a trial could expedite the understanding of PT00114's therapeutic benefits across multiple indications. This 'basket design' is an innovative strategy that may streamline the development process and provide a competitive edge. The financial implications of such a strategy are two-fold: potential cost savings in the drug development process and an expanded therapeutic reach if the drug proves effective across various disorders.
The landscape for treatments of neuropsychiatric disorders is highly competitive, with many companies vying for market share. Protagenic Therapeutics' PT00114 represents a novel approach with its synthetic stress-regulating peptide. The market potential for such a treatment is significant, considering the prevalence of stress-related disorders and the current demand for more effective therapies.
Investors should be aware of the competitive dynamics that could affect PT00114's market entry. The presence of established treatments and other drugs in development means Protagenic must not only demonstrate efficacy and safety but also differentiate PT00114 in terms of cost, dosing convenience and efficacy. The weekly subcutaneous administration could be seen as an advantage if patients prefer it over more frequent dosing schedules. The current clinical trial's focus on biomarkers also suggests a precision medicine angle that could appeal to both patients and healthcare providers, potentially positioning PT00114 favorably in the market.
Next clinical progress update expected in April 2024
NEW YORK, NY / ACCESSWIRE / March 27, 2024 / Protagenic Therapeutics, Inc. (NASDAQ:PTIX), a leader in biopharmaceutical innovation, advances its mission to develop cutting-edge treatments for stress-related neuropsychiatric disorders. The company has reached another milestone by completing three out of five cohorts of healthy volunteers with PT00114, its synthetic version of the stress-regulating peptide TCAP, in a SAD Phase 1 clinical trial. Notably, PT00114 has shown excellent tolerability with no adverse safety findings during these ongoing Phase 1 studies. With promising preclinical efficacy in anxiety, depression, PTSD, and addiction models, PT00114 moves forward in clinical evaluation, representing a step toward potentially transformative therapies.
Key Highlights:
- Safety Validation: Building on the low dose safety validation announced February 13th, PT00114 has now demonstrated safety at a medium dose of 500 micrograms administered subcutaneously in the third of five planned cohorts of subjects in the single dose portion of the Phase I trial. No adverse reactions were observed among subjects, consistent with the two lower dose cohorts (125 micrograms and 250 micrograms), with no reported injection site reactions or tolerability issues in the week following dosing. Based on preclinical pharmacology, PT00114 is expected to be administered once weekly via subcutaneous injection.
- Clinical Protocol Progress: This marks progress in the ongoing Phase 1/2a trial, designed to assess both healthy volunteers and patients diagnosed with Treatment-Resistant Depression, PTSD, or Generalized Anxiety Disorder. The company plans to enroll the final two cohorts into the single dose portion of the Phase 1 trial within the next month.
- Comprehensive Approach: In addition to monitoring disease status, the trial incorporates biomarker assessments, including circulating cortisol levels, to measure initial treatment response. Dr. Maurizio Fava, Psychiatrist-in-Chief at Massachusetts General Hospital, serves as the Principal Investigator in Protagenic's Phase 1/2a clinical trial with a basket design.
- Strategic Collaboration: Axiom Real-Time Metrics, a CRO/Data Analytics firm, manages the clinical program.
About Protagenic Therapeutics, Inc.:
Protagenic Therapeutics, Inc. (Nasdaq: PTIX) is dedicated to pioneering therapeutics based on neuro-active peptides to alleviate the negative effects of stress and treat stress-related disorders such as anxiety, depression, PTSD, and addiction. For more information, visit www.protagenic.com.
About PT00114:
PT00114, a 41-amino-acid residue synthetic peptide, shows promise as a novel treatment for serious neuro-psychiatric conditions, including depression, anxiety, and PTSD. It is a synthetic form of the naturally occurring brain peptide TCAP, which counters the negative biochemical and behavioral effects of stress-induced brain hormones Corticotropin Releasing Factor and Arginine-Vasopressin. Among its benefits is the reduction of excessive circulating levels of cortisol often associated with various stressors.
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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