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Investing.com -- Protagenic Therapeutics, Inc. (NASDAQ:PTIX) stock soared 150% after the biopharmaceutical company announced it has completed 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.
The positive market reaction follows Protagenic’s announcement that the safety data would support 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 that regulates stress and emotional balance.
Unlike existing therapies for stress-related conditions that merely address symptoms, PT00114 is thought to directly modulate the brain’s maladaptive responses to stress. This approach could offer a new treatment pathway for anxiety, depression, addiction, and Post Traumatic Stress Disorder (PTSD) - conditions where current treatments leave more than half of patients without adequate relief.
The multiple-dose study follows a successful single ascending dose trial that confirmed PT00114’s favorable safety profile. Robert Stein, M.D., Ph.D., Chief Medical (TASE:BLWV) Officer, called the initiation of the multiple-dose trial "a pivotal step" in the company’s clinical program.
Data from this trial will inform upcoming Phase 2 studies aimed at demonstrating PT00114’s therapeutic potential in stress-related and mood disorders.
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