The team at Yamo Pharmaceuticals is fully committed to advancing the development of L1‑79, a therapy designed to address the core symptoms of autism.

While the autism spectrum is broad, individuals with severe symptoms often struggle to communicate effectively, or sometimes not at all, with the world around them. Based on clinical evidence from pilot studies involving small groups of patients with moderate-to-severe behavioral, socialization, and communication symptoms, as well as anecdotal reports from their parents, we recognize the potential impact that L1-79 could have. We understand the hope that a product like L1-79 might provide, helping individuals with autism to lead more engaged and functional lives.

While we acknowledge the urgent need, we must operate within the constraints of the drug development process. Our product candidate is currently in an early stage of clinical development, meaning its safety and effectiveness have not yet been fully confirmed. We are working with the Food and Drug Administration (FDA) to build a clinical program that will provide the required safety and efficacy data to seek marketing approval for L1-79, ensuring it can reach as many patients as possible. Our goal is to move through this process as quickly as possible without compromising the scientific standards required by the FDA.

At this stage, our resources are limited, allowing us to produce only enough L1-79 for clinical studies. Diverting any supply to a pre-approval access program would unfortunately delay the progress of the L1-79 clinical program.

Therefore, we are not offering access to our investigational treatment through “compassionate use” or “pre-approval access” programs at this time. However, we plan to reassess the possibility of such programs next year as we initiate further clinical trials. Please continue to visit our website for updates.

If you are interested in participating in a clinical trial of L1-79, we encourage you and your child’s pediatrician, psychiatrist or neurologist to visit our Future Clinical Study webpage or www.clinicaltrials.gov, where we will provide information about our studies. If you wish to be notified when new studies begin, please contact us.