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Clinical studies you should know about

Clinical studies are an important part of the drug development process and a critical research tool for advancing patient care and bringing new medicines to individuals and families who need them. Enrollment in one of our clinical studies is the primary way in which we can provide individuals living with serious viral and liver diseases 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.

Individuals who participate in clinical studies help to advance new scientific discoveries and make better future treatments possible. If you or a loved one is interested in participating in a clinical study evaluating a novel investigational therapy, taking part may provide you with an option to help manage your condition. 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 participant 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.

Expanded Access Policy

We are committed to developing innovative therapeutics targeting serious viral and liver diseases. As we advance our clinical development plans, we have been thoughtful to consider when we should offer an expanded access program for patients based in the United States. Typically, these programs are introduced when a product candidate is in Phase 3 clinical development. Therefore, currently the best way to access our investigational therapies is through participation in one of our clinical trials. For information on our clinical trials see clinicaltrials.gov.

Important principles (in addition to sufficient evidence of safety and efficacy) that may be applied to any expanded access program for Assembly Bio will include that 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.

The above are general requirements, and specific requirements will be generated for a given investigational drug or clinical program when Assembly Bio initiates an expanded access program.