Protagenic Therapeutics' Stress-Regulating Peptide Demonstrates Exceptional Safety in Single Dose Portion of Phase I Trial

May 24, 2020

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 held an interactive investor call on Wednesday, May 22nd, in which they discussed the safety data set and the implications for PT00114's potential to address the unmet needs in mental health and obesity treatment.

To listen to the replay of the call, please visit this link:

For more details, visit

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.

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

Investor Relations Contact

Kirin M. Smith
PCG Advisory, Inc. 950 Third Avenue, Suite #2700, New York, NY 10022.
Tel: 646-823-8656

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.
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