Expanded Access Policy

We are a clinical-stage company dedicated to the development of novel therapeutics for diseases with high unmet medical needs, including amyotrophic lateral sclerosis (ALS) and treatment-resistant metastatic breast cancer that can reach and positively impact everyone, including patients, their families and caregivers. 

Before our therapies currently in development are fully reviewed and approved by regulatory authorities (including the U.S. Food and Drug Administration (FDA)), they can be accessed only through participation in our clinical trials. Clinical trials are controlled research studies designed to evaluate whether a new therapy is safe and effective for patients, and they provide the most direct opportunity for patients to access a new product before regulatory approval. While we are very mindful of the serious impact that these devastating diseases have on those affected, and are committed to completing the regulatory review and approval process as diligently as possible through our ongoing clinical trials, we are not currently in a position to offer Sponsor-initiated access to our therapies in development outside of these trials, either through what is known as “expanded access” or otherwise. 

What is “expanded access”? Expanded access, also known as “compassionate use,” is a process by which a limited number of qualifying patients may be granted access to an investigational product on a case-by-case basis. Requests for expanded access must be initiated by a treating physician and generally apply to patients who do not qualify for clinical trials, have exhausted all available treatment options, and have an immediately life-threatening condition or serious disease or condition, among other criteria. You can learn more about expanded access by visiting the FDA website at: Expanded Access | Information for Patients 

Although we do not currently offer Sponsor-initiated expanded access to our therapies in development, we may offer such access in the future. You can find additional information about our ongoing clinical trials by accessing https://www.leonabio.com/patients/. If you have additional questions, please consult with your physician.