Protagenic Therapeutics Completes Enrollment in Single Dose Portion of Phase 1 of Innovative Stress Disorder Trial
Protagenic Therapeutics, Inc. completes enrollment in the single dose portion of Phase 1 trial for PT00114, a synthetic stress-regulating peptide, showing outstanding tolerability. The trial aims to revolutionize treatment for neuropsychiatric disorders like anxiety, depression, PTSD, and addiction. Data from the safety trial phase are expected in May.
Completion of enrollment in the Phase 1 trial indicates progress in developing a safe and effective therapy for stress-related conditions.
PT00114 has demonstrated exceptional tolerability and no adverse safety findings, a positive sign for its potential as a treatment option.
Protagenic Therapeutics is positioned as a leader in neuro-active peptides, addressing the critical need for innovative mental health treatments.
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NEW YORK, NY / ACCESSWIRE / May 1, 2024 / Protagenic Therapeutics, Inc. (NASDAQ:PTIX), a leader in biopharmaceutical innovation, today announced the completion of enrollment in the single dose portion of its Phase 1 trial involving PT00114, its synthetic stress-regulating peptide, for treating neuropsychiatric disorders. This marks a significant milestone with the enrollment of 30 subjects across five cohorts, receiving doses up to 1,000 micrograms.
PT00114 has demonstrated outstanding tolerability with no adverse safety findings, building upon safety validations reported earlier this year. The trial progresses as PT00114 shows potential to transform treatment for anxiety, depression, PTSD, and addiction.
"Completing this phase is an important step toward developing a safe, effective therapy for those affected by severe stress-related conditions," stated Dr. Maurizio Fava, Psychiatrist-in-Chief at Massachusetts General Hospital and Principal Investigator of the study.
Data from this safety trial phase are anticipated to be announced in May. The study also includes assessments of biomarkers including cortisol levels before and after treatment.
Protagenic Therapeutics continues to lead in the development of neuro-active peptides, addressing the profound need for innovative treatments in mental health.
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
FAQ
What did Protagenic Therapeutics announce regarding PT00114?
Protagenic Therapeutics completed enrollment in the single dose portion of Phase 1 trial for PT00114, a synthetic stress-regulating peptide.
What are the potential treatment areas for PT00114?
PT00114 aims to revolutionize treatment for neuropsychiatric disorders such as anxiety, depression, PTSD, and addiction.
When are the data from the safety trial phase expected to be announced?
Data from the safety trial phase are anticipated to be announced in May.
Who is the Principal Investigator of the study?
Dr. Maurizio Fava, Psychiatrist-in-Chief at Massachusetts General Hospital, is the Principal Investigator of the study.
Where can more details be found about the study?
For more details, visit www.protagenic.com.
