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Protagenic Therapeutics Announces Completion of Enrollment and Dosing in Phase 1 MAD Study

  • Protagenic Therapeutics Inc. (NASDAQ: PTIX) announced the successful completion of enrollment & dosing for its Multiple Ascending Dose (MAD) Phase 1 study evaluating lead compound PT00114.
  • The study, conducted in healthy volunteers, assessed the safety & tolerability profile of PT00114 following multiple doses over time.
  • Executive Chairman Dr. Garo Armen confirmed all healthy volunteers have been dosed & stated the company plans to deliver a full safety analysis summation by the end of November.
  • The company expects to finalize & release top-line results from the MAD study by November 30, 2025.
  • This milestone follows the completion of a single ascending dose study in early 2025 & marks progress toward the next phase of development for the peptide-based therapeutic.
  • PT00114 is a synthetic analog of a naturally occurring brain peptide designed to regulate the body's stress response & emotional equilibrium.
  • The press release includes standard forward-looking statements regarding risks & uncertainties associated with clinical study timing & results.