Assembly Biosciences is focused on developing innovative antiviral therapeutics aimed at addressing serious viral diseases, particularly those caused by herpesviruses and hepatitis viruses. Their pipeline includes investigational therapies such as ABI-5366, which targets recurrent genital herpes, and ABI-4334, designed for chronic hepatitis B virus (HBV) infections. These programs are intended to provide significant advancements over existing treatment options, with a commitment to improving patient outcomes and quality of life. The company emphasizes the importance of clinical studies in the drug development process, which are essential for demonstrating the safety and efficacy of their investigational medicines before they can be approved for public use.

The clinical studies conducted by Assembly Biosciences are critical for advancing their therapeutic candidates. For instance, the Phase 1a/1b study for ABI-5366 evaluates its safety, tolerability, and preliminary antiviral activity in both healthy subjects and those with recurrent genital herpes. Similarly, the Phase 1b study for ABI-4334 assesses its safety and antiviral effects in patients with chronic hepatitis B. Assembly Biosciences is dedicated to ensuring that their investigational therapies are accessible to patients through these clinical trials, which are designed to meet regulatory standards and provide valuable insights into the potential benefits of their novel antiviral treatments.

United States

Assembly Biosciences, Inc. operates as a clinical-stage biotechnology company in the United States. The company develops oral therapeutic candidates for the treatment of hepatitis B virus (HBV) infection and novel class of oral synthetic live biotherapeutic candidates to treat disorders associated with the microbiome. It is involved in the development of core inhibitors that inhibit the functional activities of HBV core protein at various points in the viral lifecycle. 

Infectious Diseases

Liver Diseases

Assembly Biosciences

Hepatitis B

Liver disease

Liver infection

Assembly Bio selected 4334 based on a preclinical target drug profile that indicates enhanced target coverage and potency to prevent both formation of new virus and covalently closed circular DNA (cccDNA), which is responsible for maintaining the HBV viral reservoir. Preclinically to date, the candidate has also demonstrated pan-genotypic activity, an improved resistance profile, pharmacokinetics (PK) predicting once-daily dosing and a favorable safety profile.

ABI-4334

Genital herpes (HSV)

Sexually transmitted infections

ABI-5366, a long-acting herpes simplex virus (HSV) helicase inhibitor targeting high-recurrence genital herpes,

ABI-5366

ABI-1179

Hepatitis D

Hepatitis Delta Virus

ABI-6250 is a small molecule, oral entry inhibitor in development for the treatment of chronic hepatitis delta virus (HDV) infection. ABI-6250 targets NTCP, a human receptor on the surface of liver cells, to block viral infection, which is a clinically validated mechanism. A Phase 1a study is currently ongoing.

ABI-6250

Chronic liver disease

Disrupts HBV capsid formation by allosteric binding and interference with core protein. Inhibits virion and pgRNA particle production, inhibits de novo formation of cccDNA and downstream HBeAg and HBsAg production, and is fully active against NrtI-resistant HBV

Vebicorvir (VBR, ABI-H0731)

Disrupts HBV capsid formation by allosteric binding and interference with core protein. Inhibits virion and pgRNA particle production, inhibits de novo formation of cccDNA and downstream HBeAg and HBsAg production, and is fully active against NrtI-resistant HBV

Assembly Biosciences

Company Details