FDA Grants Fast Track Designation for Yamo Pharmaceutical’s L1-79 in Autism Spectrum Disorder

New York, May 14, 2018 (GLOBE NEWSWIRE) -- Yamo Pharmaceuticals, LLC, a clinical stage pharmaceutical company developing a novel therapy for autism spectrum disorder (ASD), announced today that the US Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug L1-79, a tyrosine hydroxylase inhibitor intended to mitigate the socialization and communication symptoms in individuals with ASD. L1-79 has shown the potential to address an unmet medical need for the treatment of the core symptoms of ASD. FDA Fast Track Designation is intended to facilitate the development and expedite the review of drugs intended to treat serious conditions and that demonstrate the potential to address unmet medical needs.

“This is an important and exciting step toward developing a much-needed treatment for the cores symptoms of ASD.  We are encouraged by the results from our first studies with L1-79 and the grant of Fast Track Designation by the FDA,” said J. Thomas Megerian, MD, PhD, Yamo Pharmaceutical’s chief medical officer and senior vice president of clinical development. “We look forward to working closely with the FDA and our advisors as we advance L1-79 through additional clinical studies.”

FDA Fast Track Designation for L1-79 is primarily based on data from a recently completed Phase II clinical study, where multiple independent outcome measures demonstrated improvement in the core social domains affected by ASD. More importantly, positive trends in these efficacy measures were seen despite the small number of subjects and short duration of the study (28 days). Subsequent clinical studies in adolescents and adults and children with ASD are planned.

About L1-79

L1-79 is an investigational drug currently in clinical development by Yamo Pharmaceuticals for the treatment of the core symptoms of ASD. It acts as a tyrosine hydroxylase inhibitor and is expected to modulate the catecholaminergic pathways implicated in ASD. Data from a recently completed Phase II clinical study with L1-79 suggests it has the potential to address an unmet medical need for the treatment of the core symptoms of ASD. Clinical studies are planned to further investigate the potential of L1-79 to improve the core socialization and communication symptoms of ASD.

About Autism Spectrum Disorder

Autism spectrum disorder or autism refers to a group of complex neurodevelopment disorders that is defined in the Diagnostic and Statistics Manual of Mental Disorders V (DSM-5) by “difficulties in social communication and social interaction, and restricted and repetitive behavior, interests or activities.”  In the US, it is estimated that 1 in 59 children have ASD, with boys being 3 to 4 times more susceptible than girls (Morbidity and Mortality Week Report Surveillance Summaries, 2018). Symptoms of repetitive and characteristic patterns of behavior and difficulties with social communication and interaction start early in childhood and continue throughout a person’s life.

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

Yamo Pharmaceuticals is a clinical stage pharmaceutical company founded in 2015 to develop L1-79, a novel therapy with the potential to improve the core symptoms of Autism spectrum disorder. Yamo Pharmaceuticals is a privately held company. More information may be found at www.yamopharma.com.

Safe Harbor Statement

This press release contains “forward-looking statements” concerning the development and commercialization of Yamo Pharmaceuticals’ products, the potential benefits and attributes of such products, and Yamo’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Yamo undertakes no obligation to update any forward-looking statements for any reason.


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