– Findings show investigational drug reduces tics by 30%; Data presentation April 5 –
Chicago, March 31, 2022 – Emalex Biosciences, Inc. (“Emalex”), a biopharmaceutical company focused on developing treatments for central nervous system (CNS) movement disorders and fluency disorders, will present an abstract — “Ecopipam in Children and Adolescents with Tourette Syndrome: Results from a Randomized, Double-Blind, Placebo-Controlled Phase 2b Study”— at the American Academy of Neurology’s (AAN) Annual Meeting, April 2-7, in Seattle.
Positive topline results from Emalex’s Phase 2b clinical study (D1AMOND Study) evaluating the efficacy and safety of ecopipam (EBS-101), an investigational, first-in-class, dopamine-1 (D1) receptor antagonist, for the treatment of pediatric patients with Tourette Syndrome, were announced in late 2021. The results were statistically significant and clinically meaningful on the primary and multiple secondary efficacy endpoints. In the study the drug was also well tolerated by study participants.
“The robust results of our ecopipam study are very encouraging, giving us momentum to continue our important work towards a safe and effective therapy for pediatric patients living with Tourette Syndrome,” said Atul R. Mahableshwarkar M.D., Chief Medical Officer, Psychiatry, and Senior Vice President of Drug Development. “I am eager to publicly share full data of our study knowing we are one step closer to finding relief for people living with this disorder.”
Abstract co-author Dr. Mahableshwarkar will present study findings on Tuesday, April 5 at 1:36 p.m. CT (11:36 a.m. PT) in Ballroom 6E at the Washington State Convention Center.
Ecopipam is an investigational first-in-class drug currently being evaluated for the treatment of Tourette Syndrome (TS) in pediatric patients and childhood-onset fluency disorder (stuttering) in adults. Ecopipam selectively blocks the actions of the neurotransmitter dopamine at the D1 receptor. Dopamine is a neurotransmitter in the central nervous system, and its receptors have been classified into two “families” based on their genetic structure: “D1” (including subtypes D1 and D5) and “D2” (including subtypes D2, D3, and D4). D1-receptor super-sensitivity may be a mechanism for the repetitive and compulsive behaviors associated with TS.
Ecopipam has been shown to be generally well tolerated in clinical trials conducted to date and has received Orphan Drug and Fast Track designation from the U.S. Food and Drug Administration for the treatment of patients with TS. Adverse events affecting primarily the central nervous system [CNS] (e.g., sedation, insomnia, psychiatric changes) and the gastrointestinal system (e.g., nausea and vomiting) are the most frequently reported side effects.
About Emalex Biosciences
Emalex Biosciences is a biopharmaceutical company focused on developing treatments for central nervous system movement disorders and fluency disorders with limited or no treatment options. Aligned with its mission, the company is evaluating treatments for children and adolescents with Tourette syndrome and adults with childhood-onset fluency disorder, or stuttering. Headquartered in Chicago, Emalex is a portfolio company of Paragon Biosciences. For more information, visit: EmalexBiosciences.com.
About Paragon Biosciences
Paragon is a life science innovator that creates, builds and funds innovative biology-based companies in cell and gene therapy, adaptive biology and advanced biotechnology. The company’s current portfolio includes Castle Creek Biosciences, CiRC Biosciences, Emalex Biosciences, Evozyne, Harmony Biosciences, Qlarity Imaging, Skyline Biosciences, and a consistent flow of incubating companies created and supported by the Paragon Innovation Capital™ model. Paragon stands at the intersection of human need, life science, and company creation. For more information, please visit https://paragonbiosci.com/.
Evelyn M. O’Connor