Emalex Biosciences, Inc (“Emalex”), a clinical-stage biopharmaceutical company focused on developing treatments for central nervous system movement disorders and fluency disorders, announced that the first adult patient has been dosed in its Phase 2 clinical trial evaluating ecopipam, the company’s investigational medicine, for the treatment of childhood-onset fluency disorder, or “stuttering.”
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The Speak Freely Study is for adults who were diagnosed with a stuttering disorder as a child and who still struggle with speaking clearly. It examines the safety of ecopipam and whether it may help improve a person’s ability to speak without stuttering. The trial is being conducted in eight US sites and is seeking volunteers. Enrollment is planned to continue through April 2021.
“Stuttering is a disorder that has significant impact on patients’ quality of life, and there are currently no FDA-approved treatments available,” said Atul Mahableshwarkar, MD, Chief Medical Officer and Senior Vice President of Drug Development at Emalex. “Having the first patient dosed in this trial represents a significant milestone for 70 million people worldwide living with stuttering. We’re proud to be evaluating this medication and are encouraged by the transformative potential it holds for patients.”
Principal investigator Gerald Maguire, MD, psychiatrist and professor and chair of psychiatry and neuroscience at the University of California, Riverside, has spent much of his professional career seeking an effective treatment for stuttering. His early research with ecopipam in patients who stutter showed encouraging results and has helped to advance the work being conducted at Emalex today.
“This is a tremendous opportunity for such an underserved patient population,” said Maguire, who also stutters. “Knowing first-hand how stuttering can be detrimental to a person’s overall well-being, I am excited to be part of this journey and the meaningful work being done by Emalex. Many people are unaware that research shows stuttering may be treatable; so there is a significant educational opportunity here that will serve those who stutter and their families.”
Emalex, founded by Paragon Biosciences, is “unceasing in its work to develop innovative treatments for central nervous system movement and fluency disorders, especially for patient populations with high unmet needs.”
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