L1-79 is an innovative treatment designed to address core social-interaction deficits in individuals with Autism Spectrum Disorder (ASD). Backed by a Phase 2a clinical study in May 2018, L1-79 received Fast Track Designation from the U.S. Food and Drug Administration (FDA), recognizing its potential to meet a significant unmet need.

In June 2024, Yamo completed a Phase 2 study (Study Y202) involving 58 adolescents and young adults with ASD. The results demonstrated statistically significant and clinically meaningful improvements on the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) Socialization Standard Score. To our knowledge, these improvements are the most substantial reported to date with any ASD medication. Notably, the gains in socialization were also reflected in positive outcomes on both clinician-rated and caregiver/parent-rated scales.

L1-79 has shown a favorable safety profile, being well-tolerated among both healthy volunteers and patients with ASD. Its efficacy is grounded in a unique mechanism of action, supported by extensive research in autism. This includes the ability to modulate catecholamine pathways, which influence critical brain functions such as mood, attention, motor skills, and social behavior. Additionally, L1-79 addresses the hyperactive CNS state often observed in autism by engaging systems that regulate brain function and gut mechanisms implicated in some forms of the disorder.

By modulating catecholaminergic signaling, L1-79 offers a promising approach to improving social communication and reducing social impairments in those with ASD.