Protagenic Therapeutics Advances PT00114 into Multiple-Dose Phase 1 Trial; Positioning for Phase 2 in Stress & Mood Disorders
Rhea-AI Summary
Protagenic Therapeutics (NASDAQ:PTIX) has announced significant progress in the clinical development of PT00114, its novel neuro-active peptide therapy. The company has completed first dose injection for all subjects in the multiple-dose portion of its Phase 1 trial, with full dosing completion expected by August end 2025.
PT00114 is pioneering as the first investigational therapy based on Teneurin C-terminus Associated Peptide (TCAP), a natural brain hormone that regulates stress and emotional balance. The drug targets the amygdala and hippocampus, offering a differentiated approach to treating anxiety, depression, addiction, and PTSD.
Following successful completion of a single ascending dose trial demonstrating favorable safety, the company anticipates topline safety data by September 2025 and plans to advance to Phase 2 efficacy studies in Q1 2026.
Positive
- Successful completion of first dose injection for all study subjects in Phase 1 multiple-dose trial
- Previous single ascending dose trial confirmed favorable safety and tolerability profile
- Novel mechanism of action targeting natural brain hormone TCAP, offering potential advantage over existing treatments
- Clear development timeline with Phase 2 trials planned for Q1 2026
Negative
- Current market treatments leave more than 50% of patients without adequate relief
- Phase 2 efficacy data still needed to demonstrate therapeutic potential
- Complex clinical development pathway for novel mechanism of action drug
News Market Reaction
On the day this news was published, PTIX gained 86.84%, reflecting a significant positive market reaction. Argus tracked a peak move of +119.3% during that session. Our momentum scanner triggered 97 alerts that day, indicating high trading interest and price volatility. This price movement added approximately $2M to the company's valuation, bringing the market cap to $5M at that time. Trading volume was exceptionally heavy at 1606.7x the daily average, suggesting very strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Dosing Completion Expected by End of August; Phase 2 Trial Expected to Begin in 1Q 2026
NEW YORK, NY / ACCESS Newswire / August 21, 2025 / Protagenic Therapeutics, Inc. (NASDAQ:PTIX), a biopharmaceutical company developing novel neuro-active peptide therapies, today announced completion of first dose injection for all study subjects in the multiple-dose portion of its ongoing Phase I clinical trial of PT00114. The company expects to complete dosing by the end of August, with topline safety data anticipated by the end of September, supporting advancement into Phase 2 efficacy studies planned for the first quarter of 2026.
PT00114 is the first investigational therapy based on Teneurin C-terminus Associated Peptide (TCAP), a naturally occurring brain hormone localized in the amygdala and hippocampus that regulates stress and emotional balance. Unlike existing therapies that blunt symptoms, PT00114 is thought to directly modulate the brain's maladaptive responses to stress-offering a differentiated approach to treating anxiety, depression, addiction, and Post Traumatic Stress Disorder (PTSD).
Current treatments leave more than half of patients without adequate relief and are burdened by significant side effects.
"Initiating the multiple-dose trial of PT00114 marks a pivotal step in our clinical program," said Robert Stein, M.D., Ph.D., Chief Medical Officer. "With dosing on track to complete this month, we are preparing to transition rapidly into Phase 2 efficacy trials."
The multiple-dose study follows a successful single ascending dose trial that confirmed PT00114's favorable safety and tolerability profile. Data from this trial will contribute to Phase 2 studies designed to demonstrate PT00114's therapeutic potential in stress-related and mood disorders.
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. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. Investors are urged to exercise caution and not place undue reliance on such statements, because they are subject to risks and uncertainties that could cause actual results to differ materially.
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
SOURCE: Protagenic Therapeutics, Inc.
View the original press release on ACCESS Newswire
FAQ
What is the current status of PTIX's PT00114 clinical trial?
When will Protagenic Therapeutics (PTIX) begin Phase 2 trials for PT00114?
How does PTIX's PT00114 differ from existing stress and mood disorder treatments?
What conditions will PT00114 target in clinical trials?
What were the results of PT00114's single ascending dose trial?
