Yamo Pharma doses first subject in Phase II autism spectrum disorder trial

The leading companies in the autism clinical trials market are Otsuka Holdings Co Ltd, F. Hoffmann-La Roche Ltd, Teva Pharmaceutical Industries Ltd, autism Speaks Inc, Johnson & Johnson, Seaside Therapeutics LLC (Inactive), Bristol-Myers Squibb Co, Curemark LLC, Eli Lilly and Co, and F

The first participant in a Phase II clinical trial of L1-79 in adolescents and young adults with Autism Clinical Trials Market disorder (ASD) has been enrolled and dosed by Yamo Pharmaceuticals.

Six US research centers served as the initial enrollment sites.

By controlling the catecholaminergic pathways that are associated with ASD, L1-79, an inhibitor of tyrosine hydroxylase, has the potential to enhance the symptoms of socialization and communication.

The multicentre, randomized, chronic-dosing Phase II trial will enroll nearly 50 individuals between the ages of 12 and 21 with a two-period, placebo-controlled crossover design.

In order to receive either a 200mg or 300mg dose of L1-79, these subjects will be assigned in a 1:1 ratio to one of two active therapy arm groups.

For the first 12 weeks of Period 1, subjects in each dosing arm will be randomly assigned to receive either L179 or a placebo twice daily.

To know about the assumptions considered for the study, Request for Free Sample Report

Participants will wash out for six weeks at the conclusion of this period before transitioning into Period 2.

In Period 2, subjects who received a placebo will receive L179, and vice versa, for an additional 12 weeks.

The primary objectives of the trial are to determine how L1-79 affects the major deficits in social communication and interaction as measured by the BOSCC, Vineland Adaptive Behavior Scale Third Edition (Vineland-3), CGI-S, and other social-communication interaction measures.

Chuck Bramlage, the CEO of Yamo, said: The insights gained from previous clinical experience with L1-79, in which a favorable tolerability profile and positive efficacy trends were observed in a smaller 28-day pilot study, inform the design of this clinical trial.

"The ongoing Phase II study will serve as a proof-of-concept to evaluate the effect of two doses of L1-79 in a placebo-controlled crossover study with two 12-week treatment periods in 50 adults and adolescents with ASD."

The only medications that are currently approved for ASD by the Food and Drug Administration of the United States are those that are designed to treat irritability that is associated with autism.


3 Blog posts