Yamo Pharmaceuticals Compassionate Use / Pre-Approval Access Policy
The team at Yamo Pharmaceuticals is singularly focused on advancing the development of L1‑79, a therapy designed to mitigate the core symptoms of autism.
While the autism spectrum is broad, patients with severe symptoms are not able to communicate well or at all with the world in which they live. Based on the clinical evidence from pilot studies in small numbers of patients with moderate-to-severe behavior, socialization and/or communication symptoms, and the anecdotal reports from the parents of these individuals, we understand the potential that a product like L1-79 would have. We appreciate the hope that a product like L1-79 would allow an individual with autism to lead an engaged and functional life.
While we recognize the immediate need, we must also work within the confines of a drug development system and the limitations that imposes. Our product candidate is currently in an early stage of clinical development and as such its safety and effectiveness has not yet been fully vetted. We are working with the Food and Drug Administration (FDA) to develop a clinical program that will provide Yamo with the necessary safety and efficacy data to seek marketing approval of L1-79 so that it may reach the greatest number of patients. Our goal is to conduct this clinical program rapidly yet without sacrificing the scientific rigor that the FDA requires.
In addition, in our early stage of development, we have limited resources and are only able to produce sufficient L1-79 for use in clinical studies. Diverting any supply to a pre-approval access program would unfortunately hamper our ability to conduct the L1-79 clinical program in a timely fashion.
We are therefore not providing access to our investigational treatment through “compassionate use” or “pre-approval access” programs at this time. However, while Yamo does not have an active compassionate use program, we will reassess the ability to provide this in the coming year as we begin the next set of clinical trials. Please continue to check our website for information.
If you are interested in participating in a clinical trial of L1-79, we encourage you and your child’s pediatrician and/or neurologist to visit our Future Clinical Study webpage or www.clinicaltrials.gov, where we will make a list of our studies available. If you would like to be notified when studies commence, please contact us.