Noema Pharma Announces Recruitment of First Patient in Orpheus Phase 2b Study of PDE10A Inhibitor gemlapodect in Adults with Childhood Onset Fluency Disorder

• Study evaluating the safety and efficacy of gemlapodect (NOE-105) in adults with Childhood Onset Fluency Disorder (also known as stuttering)
• Top-line data expected in Q4 2023

Excerpt from the Press Release:

BASEL, Switzerland and BOSTON, Aug. 04, 2022 (GLOBE NEWSWIRE) — Noema Pharma, a clinical-stage biotech company targeting debilitating central nervous system (CNS) indications, today announced the dosing of the first patient in the Orpheus Phase 2b study of Noema’s PDE10A inhibitor gemlapodect (NOE-105) in Childhood Onset Fluency Disorder (COFD—commonly known as stuttering).

Orpheus is a multi-center, 11-week prospective, placebo-controlled study to evaluate the safety and efficacy of gemlapodect as monotherapy in adults suffering from COFD. The study is expected to report at the end of 2023.

“Recruiting the first participant is an important step in the clinical investigation of gemlapodect in this indication. I am very pleased with the progress we are making in the Orpheus study with significant interest from people struggling from the condition to participate in the study,” said Dr Gerald Maguire, Principal Investigator of the Orpheus Study. “Our main goal is to evaluate the safety and efficacy of gemlapodect as a monotherapy for COFD in adults. People who stutter are looking for solutions that would enable them to achieve their full potential, both personally and professionally. In the absence of any FDA approved therapies for this condition that affects over one percent of our population, persons who stutter are eagerly awaiting an effective, safe, and proven therapy.”

Click the button below to read the entire Press Release:

Continue Reading The Press Release