Clinical trials you should know about
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 patients and families who need them. Enrollment in one of our clinical trials 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 trials 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 trials 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 or a treatment alternative for mildly to moderately active ulcerative colitis, taking part in a clinical trial 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 a clinical trial—considerations such as meeting patient eligibility criteria and committing to a process that can take months or even years to complete and known and unknown risks associated with investigational therapies. And since participating in a clinical trial comes with certain risks, you will be asked to provide your “informed consent” prior to enrolling.
HBV Program – ABI-H0731 and ABI-H2158
731 and 2158 are investigational therapies that are 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 2 open-label extension study is designed for patients with chronic HBV infection who have opted to roll-over from studies 201 and 202. The study will evaluate the longer-term safety and efficacy of ABI-H0731 in combination with standard of care therapy as measured by changes in viral biomarkers over time.
Enrollment is now complete.
This Phase 1a/b study is designed for healthy subjects and patients with chronic HBV infection who are HBeAg positive or negative and are not currently on standard-of-care “Nuc” therapy. To evaluate the dose-related safety, pharmacokinetics and antiviral activity of ABI-H2158, patients will be randomly assigned to receive ABI-H2158 or placebo for 14 days.
Microbiome Program – ABI-M201
M201 is Assembly Bio’s first investigational oral live biotherapeutic product (LBP) to enter into clinical development in patients with mildly to moderately active ulcerative colitis. M201 will be orally administered utilizing our patented Gemicel® capsule-in-capsule delivery system, designed for targeted delivery into the GI tract.
This Phase 1b study is designed for patients with mildly to moderately active ulcerative colitis (UC) with ongoing mesalamine treatment. To evaluate safety, efficacy and exploratory endpoints, patients will be randomly assigned to receive ABI-M201 or placebo once daily for 8 weeks.
For more information about Assembly Bioscience’s clinical trials, please refer to www.ClinicalTrials.gov.