Emalex Biosciences Expands CNS Platform to Advance Treatment for Restless Legs Syndrome with Augmentation

Emalex Biosciences Expands CNS Platform to Advance Treatment for Restless Legs Syndrome with Augmentation

License agreement secures potential research of ecopipam for one of the most common neurological sensory disorders

Emalex Biosciences

Chicago, March 1, 2022 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).

“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.

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About Ecopipam
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 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 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, 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/.

 

Media Contacts:

Evelyn M. O’Connor
Paragon Biosciences
312-847-1335
eo@paragonbiosci.com

License agreement secures potential research of ecopipam for one of the most common neurological sensory disorders

Emalex Biosciences

Chicago, March 1, 2022 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).

“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 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 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 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, 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/.

 

Media Contacts:

Evelyn M. O’Connor
Paragon Biosciences
312-847-1335
eo@paragonbiosci.com