Boston — Xylo Bio has dosed the first participants in a Phase 1 clinical trial of XYL-1001, a selective 5-HT2A receptor agonist being developed for major depressive disorder.
The milestone moves the biotechnology company into clinical-stage development.
The randomized, double-blind, placebo-controlled study is being conducted in Australia and will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic activity of XYL-1001 in healthy volunteers.
The trial includes single ascending dose and multiple ascending dose cohorts and incorporates translational biomarkers intended to measure pharmacodynamic activity and inform future clinical development.
“Major depressive disorder remains one of the most difficult conditions to treat, and too many patients have exhausted existing options without relief,” said Gabriel Vargas, M.D., Ph.D., Chief Clinical Advisor at Xylo Bio. “This Phase 1 study is designed to rigorously characterize XYL-1001’s safety and pharmacology from the outset, giving us the foundation we need to move quickly and responsibly toward patients who need alternatives.”
XYL-1001 is designed to activate the 5-HT2A receptor without producing hallucinogenic effects. Xylo Bio said the candidate has demonstrated 5-HT2A-dependent neuroplastic effects and efficacy in preclinical models of anxiety and depressive-like behaviors without signs of hallucinogenic-related behavior.
“Dosing our first participants is a meaningful inflection point for Xylo Bio,” said Samuel Banister, Ph.D., Chief Scientific Officer and Co-Founder. “Our mission is to unlock the therapeutic potential of the 5-HT2A receptor without the hallucinogenic burden and supervised dosing that limits who can access these treatments. This trial brings us one step closer to delivering on that mission.”
The company is also presenting the program at the Neuropsychiatric Drug Development Summit in Boston.
XYL-1001 remains investigational and has not been approved by any regulatory authority.
