Clinical Trial Progress: Protagenic Therapeutics has completed the first dose injection for all participants in the multiple-dose phase of its Phase I clinical trial for PT00114, with full dosing expected by the end of August.
Safety Data Timeline: Topline safety data from the trial is anticipated by the end of September, which will inform the transition to Phase 2 efficacy studies planned for early 2026.
Innovative Therapy Approach: PT00114 is based on a naturally occurring brain hormone and aims to directly modulate maladaptive stress responses, offering a new treatment strategy for anxiety, depression, addiction, and PTSD.
Previous Trial Success: The current multiple-dose study follows a successful single ascending dose trial that confirmed PT00114's favorable safety and tolerability profile, supporting its potential in treating mood disorders.
Protagenic Therapeutics, Inc. is a neuroactive biopharmaceutical company. The Company has approximately six drug candidates targeting stress-related and CNS disorders, including treatments for obesity and metabolic disorders. The Company's pipeline includes PT-00114 in Phase I/IIa and five preclinical assets including PHYX-001, cannabinoid-based compounds, and modified stilbenoid assets. The PHYX-001 is a potassium channel modulator with a mechanism similar to XEN1101 and BHV-7000. The Company's cannabinoid assets include multiple cannabinoid-based compounds with composition-of-matter IP; potential in CNS, cardiometabolic, and other indications. The Company's cannabinoid assets also include a molecule with potential in the obesity, metabolic dysfunction sector, where the GLP-1 agonists have become medications. Its modified stilbenoid assets include modified stilbenoid compounds with composition-of-matter IP and anticonvulsant activity in preclinical models.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
