Protagenic Therapeutics' Stress-Regulating Peptide Demonstrates Exceptional Safety in Single Dose Portion of Phase I Trial, Paving the Way for Next Steps Toward Potential Breakthrough Treatments in Stress Related Neuropsychiatric Disorders
Protagenic Therapeutics (NASDAQ: PTIX) announced promising safety results from the single dose portion of its Phase 1 trial for PT00114, a stress-regulating peptide. The trial involved 30 subjects across five cohorts who received doses up to 1,000 micrograms. No clinically-relevant adverse events were reported. PT00114 aims to address stress, a key factor in psychiatric disorders such as PTSD, depression, anxiety, addiction, and potentially obesity. The multiple dose portion of the trial will commence later this year. An investor call is scheduled for May 22, 2024, at 10:00 am ET to discuss these findings.
- No clinically-relevant adverse events reported in Phase 1 single dose trial.
- Involvement of 30 subjects across five cohorts receiving doses up to 1,000 micrograms.
- PT00114 targets stress, a root cause of major psychiatric disorders like PTSD, depression, anxiety, and addiction.
- Evidence suggests stress may also contribute to obesity.
- Plans to commence multiple ascending dose portion of the trial later this year.
- Investor call scheduled to discuss potential impact on mental health and obesity treatment.
- Results are from a single dose trial; long-term effects and efficacy remain unproven.
- Multiple dose portion of the trial has not yet started, indicating a longer timeline to potential market availability.
- No mention of financial implications or cost projections for the continued trials and potential treatments.
Insights
The safety results from the single dose portion of PT00114's Phase 1 trial are indeed significant. Given the absence of clinically-relevant adverse events in all 30 subjects, this indicates a favorable safety profile, which is a critical first step in drug development. Since PT00114 targets stress, a precursor to numerous psychiatric and metabolic disorders, its potential is far-reaching. If subsequent trials can confirm both safety and efficacy, PT00114 could address gaps in current treatments for PTSD, depression, anxiety, addiction and possibly obesity. The focus on a stress-regulating peptide is innovative, as it targets the underlying cause rather than just the symptoms.
However, it's important to note that these are early-stage results. The upcoming multiple dose portion will be important in understanding the drug's long-term safety and potential efficacy. Investors should be cautiously optimistic but remain aware of the typical challenges in drug development, especially for neuropsychiatric conditions.
From a financial perspective, Protagenic Therapeutics' announcement is encouraging. The positive safety data supports further development and could attract additional investment. Successfully moving to the next phase without adverse events reduces financial risk and increases the likelihood of future funding or partnerships. If PT00114 progresses through clinical trials, it could represent a significant revenue opportunity given the substantial market for effective mental health treatments.
However, the company remains in the early stages of clinical trials, which means it may still be years before any potential product reaches the market. The upcoming trials and investor updates will be pivotal. Investors should monitor these developments closely while considering the inherent risks in biotech investments.
No Clinically-Relevant Adverse Events Reported in Single Dose Portion, Multiple Dose Portion to Commence
Investor Call Scheduled for today, Wednesday, May 22, at 10:00 am ET to Discuss Potential Impact on PTSD, Depression, Anxiety, Addiction, and Obesity
NEW YORK, NY / ACCESSWIRE / May 22, 2024 / Protagenic Therapeutics, Inc. (NASDAQ:PTIX), a leader in biopharmaceutical innovation, today announced the complete safety data set from the single dose portion of its Phase 1 trial involving PT00114, its synthesized version of a natural stress-regulating brain peptide. The trial, which included 30 subjects across five cohorts receiving doses up to 1,000 micrograms, reported zero clinically-relevant adverse events.
PT00114 targets stress reduction, which is increasingly recognized as the root cause of major psychiatric disorders, including PTSD, depression, anxiety, and addiction. Emerging evidence also suggests that stress may be a significant contributor to obesity. By addressing the stress-chemical cascade, PT00114 has the potential to offer a novel approach to treating these conditions.
"The exceptional safety results from the single dose portion of the Phase I trial are highly encouraging," commented Dr. Robert B. Stein, Chief Medical Officer. "We are eager to begin the multiple ascending dose portion later this year, since PT00114 shows promise to revolutionize treatment for a wide range of stress-related disorders."
The company will hold an interactive investor call today, Wednesday, May 22nd, at 10:00 am ET to discuss the safety data set and the implications for PT00114's potential to address the unmet needs in mental health and obesity treatment. To participate, please use the link:
https://www.webcaster4.com/Webcast/Page/3027/50682
or the dial-in by phone number
Toll Free: 888-506-0062
International: 973-528-0011
Participant Access Code: 740983
and join at least five minutes before the scheduled start time.
For more details, visit www.protagenic.com.
About PT00114: PT00114 is a candidate to become a therapeutic for severe neuropsychiatric conditions, mimicking the naturally occurring brain peptide TCAP to counteract stress-induced hormonal effects.
Forward-Looking Statements: Statements in this release about future expectations are "forward-looking" and subject to risks and uncertainties. Investors are cautioned against placing undue reliance on such 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.
View the original press release on accesswire.com
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