FDA Fast-Tracks Treatment for Autism Spectrum Disorder

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L1-79 is a tyrosine hydroxylase inhibitor.
L1-79 is a tyrosine hydroxylase inhibitor.

Yamo announced that the Food and Drug Administration (FDA) has granted Fast Track designation to L1-79, a new drug candidate intended to mitigate the socialization and communication symptoms in patients with autism spectrum disorder (ASD). There are currently no approved pharmacological treatments that address these core symptoms of ASD.

L1-79 is a tyrosine hydroxylase inhibitor that is believed to work by modulating the catecholaminergic pathways involved in ASD. Findings from a Phase 2 study showed that within days of initiating L1-79, patients experienced reductions in irritability, lethargy, hyperactivity, and anxiety, as well as improvements in speech, communication, socialization, and awareness of self and others. Although the 28-day study included a small sample size, positive trends in clinical benefit were observed, and the treatment was well tolerated in all patients.  

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.”

For more information visit YamoPharma.com.

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