Yamo Pharmaceuticals Enrolls Final Patient in Phase 2 Study Evaluating L1-79 to Treat the Core Symptoms of Autism Spectrum Disorder
NEW YORK, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Yamo Pharmaceuticals LLC (Yamo), a clinical stage pharmaceutical company, announced today that it has completed enrollment in its Phase 2 study evaluating L1-79 in adolescents and young adults with autism spectrum disorder (ASD). Top-line data from the trial are expected in August 2024. With the completion of Phase 2 enrollment, Yamo has initiated a Phase 3 readiness program to optimize L1-79’s development timeline.
L1-79 is a tyrosine hydroxylase inhibitor designed to improve the core socialization and communication symptoms of ASD by modulating the catecholaminergic pathways implicated in ASD. In 2018, Yamo received Fast Track designation for L1-79 from the Food and Drug Administration (FDA) based on the promising results of its Phase 2a study. Currently, the only FDA-approved drugs for ASD are indicated for ASD-associated irritability. No medications are available to treat core symptoms of ASDi, such as socialization and communication.
“We are excited that enrollment in our Phase 2 proof-of-concept study for L1-79 use in treating ASD is now complete and look forward to beginning business development discussions ahead of the data readout next summer,” said Chuck Bramlage, Yamo’s Chief Executive Officer.
“We would like to thank the families and their children for participation, as well as the research sites that have helped us get to this point. We are excited to share data from this study as it will provide further insights into the role of the catecholaminergic system in regulating social-communication function in autism,” said J. Thomas Megerian, MD, PhD, Yamo’s Chief Medical Officer.
Today’s announcement signals hope for patients and families that medicines are in development to treat the core deficits in social-communication and social interaction associated with ASD.
About the Study
To be eligible to participate in the study, individuals must have been diagnosed with ASD with a score of = 70 on the Wechsler Abbreviated Scale of Intelligence (WASI-II), and a score of = 4 on the Clinical Global Impression of Severity of Illness (CGI-S) weighted for socialization. Key objectives of the study are to evaluate the effect of L1-79 on the core deficits in social-communication and interaction using the Vineland-3, CGI-S, and other measures of social-communication and interaction. Please refer to study identifier NCT05067582 at www.clinicaltrials.gov for additional clinical trial details.
About Autism Spectrum Disorder
While the causes of ASD are not known, research suggests that both genes and environment play important roles. Since the severity, specific types of symptoms, and causes of ASD vary between individuals, it is referred to as a ‘spectrum’ disorder. Currently there are no approved pharmacological therapies which address the core symptoms of ASD.
About Yamo Pharmaceuticals
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Investor and Media Contacts
Eugene Prahin, CFO
i Treatment and Intervention Services for Autism Spectrum Disorder. March 9, 2022. U.S. Centers for Disease Control and Prevention. https://www.cdc.gov/ncbddd/autism/treatment.html. Accessed Nov. 14, 2023.
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