Axcella is a clinical-stage biotechnology company that is pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). Our current generation of EMM compositions incorporate multiple amino acids and their derivatives in distinct ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency.

EMM compositions that are being developed as drug product candidates are being investigated in well-controlled clinical trials under Investigational New Drug applications cleared by the FDA or Clinical Trial Applications in countries outside the U.S. For more information about Axcella’s ongoing clinical trials, please visit www.ClinicalTrials.gov and search using the term “Axcella”.

Expanded access, also referred to as compassionate use, allows patients with serious or immediately life-threatening diseases or conditions to be treated with investigational drugs outside of clinical trials when no comparable or satisfactory alternative therapy options are available. The primary purpose of expanded access programs is to diagnose, prevent or treat a serious condition (i.e., a condition associated with morbidity that has substantial impact on day-to-day functioning). This is different from a clinical trial that seeks to obtain safety and efficacy information on an investigational drug product.

At this time, Axcella believes that participation in one of its clinical trials is the most appropriate way for patients to access the company’s investigational therapies. Should you have any questions, please speak with your physician or contact clinicalteam@axcellatx.com. Axcella expects to acknowledge receipt of requests sent to this email address within five business days.

Axcella reserves the right to revise this policy at any time, as authorized by and in accordance with the 21st Century Cures Act.