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Emalex Biosciences Recruiting People Who Stutter for Phase 2 Clinical Trial for Childhood-Onset Fluency Disorder

CHICAGO, Sept. 14, 2021. Emalex Biosciences, Inc. ("Emalex"), a biopharmaceutical company focused on developing treatments for central nervous system movement disorders and fluency disorders, is seeking people who stutter to complete its Phase 2 clinical trial enrollment for childhood-onset fluency disorder in adults, also known as stuttering. The study recently reached its 75% enrollment milestone (51 of 68 participants) and is looking to complete full enrollment by the end of 2021.

The Speak Freely Study is for adults who were diagnosed with a stuttering disorder as a child and who still struggle with speaking clearly. Eligible participants will take study medication for 12 weeks and have health and safety assessments at clinic visits throughout for approximately 16 weeks at one of the following locations:

Atlanta, GA
Brooklyn, NY
Jacksonville, FL
Memphis, TN
Okemos (Lansing), MI
Orlando, FL
Prairie Village, KS
Riverside, CA
Santa Ana, CA


"Enrolling three quarters of the patients for our study, even with the challenges imposed by the COVID-19 pandemic, is a testament to the great need for a therapy for people who stutter," said Atul R. Mahableshwarkar, M.D., chief medical officer and senior vice president of drug development for Emalex. "We are eagerly looking forward to completing enrollment as a step forward in our journey for a new potential treatment option specifically for people who stutter."

The study is evaluating ecopipam, an investigational first-in-class drug, to determine whether it may help improve the ability to get words out without stuttering. Currently there is no U.S. Food and Drug Administration approved medication specifically to treat stuttering, however, some drugs have been used off-label for treatment with side effects that make continual use difficult.

Recently, Emalex completed a $35 million raise in Series C Preferred Stock funding led by Paragon Biosciences, to support the organizational operations through trial completion.

About Ecopipam
Ecopipam is an investigational first-in-class drug being evaluated for the treatment of childhood-onset fluency disorder (stuttering) in adults and Tourette syndrome (TS) in pediatric patients. 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. 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 childhood-onset fluency disorder, or stuttering, and for children and adolescents with Tourette syndrome. Headquartered in Chicago, Emalex is a portfolio company of Paragon Biosciences. For more information, visit: EmalexBiosciences.com.

About Paragon Biosciences
Paragon is a global life science leader that creates, bulids and funds innovative biology-based companies in three key areas: 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.

SOURCE Emalex Biosciences, Inc.

Posted: September 2021

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