Clinical studies are an important part of the drug discovery process and a critical research tool for advancing patient care and bringing new medicines to patients and families who need them. Enrollment in one of our clinical studies is the primary way in which we can provide patients access to our investigational drugs prior to their potential approval by regulatory authorities, such as the United States Food and Drug Administration. Clinical studies are required to demonstrate that an investigational medicine meets necessary safety and effectiveness standards before it is approved and becomes commercially available to the public.

Patients who participate in clinical studies help advance new scientific discoveries and make better future treatments possible. If you or a loved one are interested in participating in a clinical study evaluating novel therapy for hepatitis B virus (HBV) infection, taking part in a clinical study may provide just the initiative and reinvigorated hope you’re looking for. It is important to understand, however, that there are inherent risks and other obstacles to consider when thinking about participating in a clinical study—considerations such as meeting patient eligibility criteria; committing to a process that can take months or even years to complete; and understanding the known and unknown risks associated with investigational therapies. And since participating in a clinical study comes with certain risks, you will be asked to provide your “informed consent” prior to enrolling.

• Our program will be consistent with regulatory agency guidelines and approval processes.
• The request must be made by the patient’s treating physician. The physician must be appropriately licensed [and in good standing]. The risk-benefit of receiving the therapy must be assessed and confirmed by the requesting physician and will be further assessed by Assembly Bio.
• Informed consent, regulatory and institutional approvals must be secured to act on any request lawfully and responsibly.
• Competent health care facilities must be available that are appropriate to administer therapy, manage potential side effects, and monitor the patient with appropriate follow-up.

• The disease condition of the patient involved must be serious or life-threatening, with no other satisfactory treatment options (including approved products) or open/pending clinical trials available.
• Expanded access will not adversely impact Assembly Bio’s clinical development program or the regulatory approval process.
• Adequate supply of the product exists, manufacturing capability is maintained for ongoing programs, and it is logistically feasible to make the therapy available outside of a clinical trial setting.
• Our programs will support use of Assembly Bio’s therapies for the indicated disease condition[s] and will not be available to treat other diseases.