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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 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.

ABI-5366 and ABI-1179

ABI-5366 and ABI-1179 are investigational therapies in development for the treatment of recurrent genital herpes. Genital herpes can be caused by either herpes simplex type 1 virus (HSV-1) or herpes simplex type 2 virus (HSV-2), but recurrences are more likely to be experienced by individuals with HSV-2. Approximately 50% of individuals with initial symptomatic genital herpes infection have three or more recurrences per year.

ABI-4334

ABI-4334 is an investigational therapy that is being evaluated in clinical studies for the treatment of patients with chronic hepatitis B virus (HBV) infection, a disease of the liver that afflicts approximately 254 million people worldwide and is a leading cause of chronic liver disease and liver transplants.

ABI-6250

ABI-6250 is an investigational therapy in development for the treatment of chronic hepatitis D virus (HDV) infection, which affects a subset of approximately 12-72 million of cHBV-infected people worldwide. HDV is considered the most severe form of viral hepatitis and accelerates disease progression and increases the incidence of liver cirrhosis and liver cancer in cHBV-infected individuals.

Study Study Design
ABI-5366-101

This Phase 1a/1b study is evaluating the safety, tolerability, pharmacokinetics and preliminary antiviral activity of ABI-5366 in healthy participants and participants with recurrent genital herpes
ABI-1179-101

This Phase 1a/1b study is evaluating the safety, tolerability, pharmacokinetics and preliminary antiviral activity of ABI-1179 in healthy participants and participants with recurrent genital herpes
ABI-4334-102

This Phase 1b study is evaluating the safety, tolerability, pharmacokinetics, and antiviral activity of ABI-4334 in participants with chronic hepatitis B
ABI-6250-101

This Phase 1a study is evaluating the safety, tolerability and pharmacokinetics of ABI-6250 in healthy participants

Expanded Access Policy

We are committed to developing innovative therapeutics targeting serious viral 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.