Expanded Access Policy
To ensure the highest scientific and medical confidence in our products, Cabaletta Bio believes that investigational drugs should be studied within clinical trials designed to obtain data on safety and efficacy that may be used to support approval of the product, enabling wide accessibility to appropriate patients. We encourage patients to speak with their physicians and to participate in clinical trials. However, at the appropriate stage of development and with the availability of clinical data as described below, Cabaletta Bio will consider providing an investigational drug outside of a clinical trial for patients who have the serious or life-threatening disease or condition for which Cabaletta Bio is developing its investigational product(s), but who are unable to participate in clinical trials and who have exhausted all available therapies.
As a general policy, Cabaletta Bio will not provide an investigational drug product until there is sufficient clinical data from its existing clinical trial(s) to identify an appropriate dose and to assess preliminary safety and efficacy information to make a benefit-risk analysis consistent with the establishment of an expanded access (otherwise known as compassionate use) program. This would not be expected to occur earlier than the end of Phase 2 studies, and depending on the clinical program, potentially even later. At such a time, Cabaletta expects to provide additional criteria for which expanded access requests would be evaluated. Currently, given the early stage of development, none of Cabaletta Bio’s investigational products are available for expanded access.
More information about our clinical trial can be found at clinicaltrials.gov. A treating physician may submit questions regarding expanded access to the following: ClinicalTrials@cabalettabio.com. While patients or non-healthcare professionals are advised to speak with their doctors, they may also submit questions or seek more information directly from Cabaletta Bio at this email address. Cabaletta Bio expects to acknowledge receipt of inquiries within five business days.
As authorized by the 21st Century Cures Act, Cabaletta Bio may revise this expanded access policy at any time and the posting of the policy by Cabaletta Bio shall not serve as a guarantee of access to any specific investigational drug for any patient.