Clinical trials are an important part of the drug discovery process and a critical research tool for advancing patient care and bringing new medicines to the market. Enrollment in one of our clinical trials is our primary method for providing patients with access to our investigational drugs prior to their potential approval by regulatory authorities, including the United States Food and Drug Administration, and subsequent commercial availability. Clinical trials are required to demonstrate that an investigational drug meets safety and efficacy standards necessary for approval by regulatory authorities.
For those patients seeking a cure or an alternative treatment option, participating in a clinical trial can create hope and excitement. Patients who are willing to participate in clinical trials help make new scientific discoveries possible by supporting the clinical trial process that is required to bring new therapies to patients in need. It is important for patients to understand that there are inherent risks and other obstacles to consider, such as meeting patient eligibility criteria and committing to a process that can take months or even years to complete. As participation in a clinical trial comes with risks, you must also provide your "informed consent" prior to enrolling in a clinical trial.
Assembly Biosciences is currently conducting two clinical trials:
ABI-H0731 is an investigational therapy that is being studied to treat patients with chronic hepatitis B virus (HBV), an infectious disease of the liver that afflicts over 250 million people worldwide and is a leading cause of chronic liver disease and liver transplants.
|This Phase 2a trial is enrolling patients with chronic HBV infection who are HBeAg positive and are currently on nucleoside or nucleotide therapy with fully suppressed viral loads. Patients will continue their therapy and will also be randomly assigned to receive treatment with either ABI-H0731 or placebo for 6 months.|
|ABI-H0731-202||This Phase 2a trial is enrolling patients with chronic HBV infection who are HBeAg positive and have not received prior nucleoside or nucleotide treatment. Patients will be randomly assigned to receive treatment for 6 months with either entecavir (a standard therapy) + ABI-H0731 or entecavir + placebo.|