SymBio`s Expanded Access Policy

What is expanded access use?

Expanded access (also known as "compassionate use") is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

Expanded access may be appropriate when all the following apply:

• The patient has a serious or immediately life-threatening disease or condition.
• There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
• The enrollment of the patient in a clinical trial is not possible.
• The potential patient benefit justifies the potential risks of treatment.
• Providing the investigational medical product will not interfere with investigational trials that could support a medical product's development or marketing approval for the treatment indication.

What is SymBio's expanded access policy for brincidofovir?

Brincidofovir is not currently approved by the United States Food and Drug Administration (FDA) nor any other regulator for any indication, except for the approval granted by the FDA for the treatment of smallpox. SymBio is committed to making brincidofovir available to patients in need as soon as possible through expedited clinical development. We are currently conducting a global Phase 3 clinical trial to evaluate the efficacy and safety of brincidofovir intravenous formulation (BCV IV) for treatment of adenovirus infection after hematopoietic stem cell transplantation (ClinicalTrials.gov Identifier: NCT07387367). BCV IV may or may not be effective in the treatment of serious adenoviral diseases, and use of BCV IV may cause serious unexpected side effects. Requests for expanded access will be considered provided that they meet the company’s eligibility criteria.

Expanded access inquiries

If you would like to contact us with an inquiry or request relating to expanded access, please contact us through the inquiry page. Please do not include the patient’s name or other identifying information. Inquiries or requests from treating physicians are generally acknowledged within 3 business days of receipt.

Policy updates and amendments

SymBio reserves the right to modify this Expanded Access Policy at any time. Any updates to the policy will be posted on this webpage. Additionally, the posting of this policy or any updated policy by SymBio does not serve as a guarantee of access to any specific investigational drug by any individual patient.