New York , May 14, 2019 (GLOBE NEWSWIRE) -- Yamo Pharmaceuticals, LLC, a clinical stage pharmaceutical company developing a novel therapy for autism spectrum disorder (ASD), announced the presentation of results from a Phase 2 study with L1-79 in the treatment of ASD. A poster entitled “An Open Label and Double Blind Randomized Placebo Controlled Pilot Study of L1-79 [D,L Alpha-Methyl-Para-Tyrosine (DL-AMPT)] for the Treatment of the Core Symptoms of Autism Spectrum Disorder (ASD) in Adolescent and Young Adult Males" was presented on Friday May 3rd during the International Society for Autism Research (INSAR) Annual Meeting in Montreal, Canada. The INSAR is a scientific and professional organization devoted to advancing knowledge about autism spectrum disorders.
“The results from this study were very encouraging as positive trends were demonstrated across multiple efficacy measures of socialization in adolescent and young adult males with ASD, despite the small number of subjects and short duration of the study,” said J. Thomas Megerian, MD, PhD, Yamo Pharmaceuticals’ chief medical officer. “There was significant interest and enthusiasm generated by the poster presentation among INSAR attendees.”
In the Phase 2 randomized, double-blind, and placebo-controlled study, 31 males between ages of 13 and 21 with a diagnosis of ASD received L1-79 100 mg, L1-79 200 mg or placebo administered three times per day (TID) for 28 days. Compared to placebo, study participants receiving L1-79 200 mg showed trends in improvements in aspects of social functioning and in repetitive restrictive behaviors (RRBs). While results did not reach statistical significance, the positive trends suggest that modulation of catecholaminergic neurotransmitters in ASD may be a viable strategy for therapeutic intervention. Yamo Pharmaceuticals is planning to conduct a larger study in adolescents and young adults with ASD to further assess the potential of L1-79.
L1-79 is an investigational drug currently in clinical development by Yamo Pharmaceuticals for the treatment of the core symptoms of ASD. L1-79 was granted Fast Track Designation by the Food and Drug Administration in May of 2018. It acts as a tyrosine hydroxylase inhibitor and is expected to modulate the catecholaminergic pathways implicated in ASD. Clinical studies are planned to further investigate the potential of L1-79 to improve the core 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 Pharmaceuticals 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 Pharmaceuticals undertakes no obligation to update any forward-looking statements for any reason.
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