At Cortexyme, we are committed to developing therapeutics based on a new theory of the cause of Alzheimer’s and other degenerative disorders. We currently are focused on enrolling and completing our ongoing clinical trials. We hope these trials will demonstrate safety and efficacy, thereby supporting regulatory approval that will help the broadest number of patients possible.
What is Expanded Access?
Expanded access, also known as “compassionate use,” refers to a program that enables some patients to gain access to an investigational therapy outside of a clinical trial. This is permitted in in certain circumstances. The primary purpose of a clinical trial is to obtain information about the safety or efficacy of an investigational drug, whereas the primary purpose of expanded access is to diagnose, monitor, or treat a patient’s disease or condition. Expanded access programs are voluntary and, when offered, are only available to patients with a serious disease or condition, who lack other treatment options.
Cortexyme’s Expanded Access Policy
At this time, Cortexyme believes that participating in one of our clinical trials is the most appropriate way to access our investigational therapies. We do not currently offer access to our investigational therapies outside of these trials, including through an expanded access program.
While our investigational therapies are not currently available through an expanded access program, you may be eligible to enroll in one of our ongoing or future clinical studies. See more information at www.gaintrial.com.
Cortexyme may revise this policy at any time. If we modify our policy, we will post the updated policy on our website and will include details regarding the procedure for making a request for expanded access and the criteria that we will use to evaluate such a request.
If you have any questions about our expanded access policy, please ask your physician to contact firstname.lastname@example.org. We anticipate that we will respond to an inquiry within 30 days.