Emalex Biosciences, Inc. (“Emalex”), a biopharmaceutical company focused on developing treatments for central nervous system (CNS) movement disorders and fluency disorders, today announced that it has entered into a license agreement with East Carolina University.
| CHICAGO, March 1, 2022 /PRNewswire/ -- Emalex Biosciences, Inc. (“Emalex”), a biopharmaceutical company focused on developing treatments for central nervous system (CNS) movement disorders and fluency disorders, today announced that it has entered into a license agreement with East Carolina University. Under the agreement, Emalex has licensed the patent rights of ecopipam (EBS-101), an investigational, first-in class dopamine-1 (D1) receptor antagonist, to potentially advance clinical studies for the treatment of Restless Legs Syndrome with augmentation (RLSa). Approximately 5%-10% of the general population is impacted by RLS, making it the most common movement disorder. “This licensing agreement provides Emalex with an expansion of its platform to address an unmet need for those living with RLSa, which currently does not have a U.S. Food & Drug Administration-approved treatment,” said Atul Mahableshwarkar, Chief Medical Officer and Senior Vice President of Drug Development. “We look forward to evaluating ecopipam to determine if it can provide much needed relief for those whose quality of life and sleep, are impacted by this condition.” RLS, also referred to as Willis-Ekbom Disease, is a neurological sensory disorder characterized by an irresistible urge to move one’s legs due to uncomfortable sensations. According to the International Parkinson and Movement Disorder Society, approximately 5%-10% of the general population is impacted by RLS, making it the most common movement disorder. RLSa is the worsening of RLS symptoms despite treatment with conventional therapies. Emalex is currently evaluating ecopipam for the treatment of Tourette syndrome (TS) in pediatric patients and childhood-onset fluency disorder (stuttering) in adults. Topline results for the pediatric Tourette’s Phase 2b clinical study were positive. Statistically significant, clinically meaningful results were obtained on the primary, key secondary endpoints along with significant results on other secondary efficacy endpoints and showed that ecopipam was well tolerated in this study. The company is preparing to meet with the U.S. Food & Drug Administration and other global regulatory agencies in the coming months to discuss next steps related to the drug approval process. Full data from the study, including the specifics of the primary efficacy and safety dataset, will be presented at an upcoming scientific conference and submitted for scientific peer-review publication. About Ecopipam 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 About Paragon Biosciences Media Contact: Evelyn M. O’Connor
SOURCE Emalex Biosciences, Inc. |
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