Assembly Biosciences, Inc. is a biotechnology company, which engages in the development of products for infectious diseases, such as chronic hepatitis B virus and illnesses associated with a dysbiotic microbiome. It focuses on two innovative platform programs: oral therapeutics for the treatment of hepatitis B virus, and the oral synthetic live biotherapeutics candidate. The company was founded by Uri Lopatin and Derek A. Small on October 7, 2005 and is headquartered in South San Francisco, CA.
Clinical Trials
26
6 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2005
Active, not recruiting
5
19.2%
Completed
14
53.9%
Not yet recruiting
1
3.9%
Terminated
6
23.1%
No approval data available
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- Assembly Biosciences reported striking Phase I results for two investigational herpes drugs, with ABI-1179 achieving a 98% reduction in HSV-2 viral shedding and 91% reduction in genital lesions compared to placebo. - The weekly oral drug ABI-1179 exceeded the company's target of 80-85% shedding reduction, while monthly candidate ABI-5366 demonstrated 76% reduction in viral shedding and 88% decrease in confirmed genital lesions. - Both helicase-primase inhibitors showed superior efficacy potential compared to current nucleoside analog treatments, with Assembly planning Phase II trials for ABI-5366 by mid-2026. - Guggenheim analysts called the data "striking" and noted the potential for ABI-1179 to unlock a "blockbuster novel weekly treatment opportunity" for recurrent genital herpes.
- Assembly Biosciences presented positive Phase 1b data for ABI-4334, a next-generation capsid assembly modulator targeting chronic hepatitis B infection, at the AASLD Liver Meeting. - The study demonstrated favorable safety and tolerability profiles with multi-log declines in HBV DNA and pregenomic RNA at both 150 mg and 400 mg doses over 28 days. - ABI-4334 achieved exposures multiple folds above levels required for inhibition of cccDNA formation, supporting engagement of both CAM mechanisms of action. - Under the collaboration agreement with Gilead Sciences, Gilead has the right to opt in for exclusive licensing after reviewing the complete Phase 1b data package.
- Assembly Biosciences has dosed the first participant in the Phase 1b portion of its clinical trial evaluating ABI-1179, a long-acting herpes simplex virus helicase-primase inhibitor for recurrent genital herpes. - The Phase 1b study will assess safety and antiviral activity of weekly oral doses over 29 days, measuring viral shedding rates and HSV-2 DNA levels in participants with recurrent genital herpes. - Both ABI-1179 and ABI-5366 are running concurrent Phase 1b studies with interim data expected in fall 2025, supported by Gilead Sciences collaboration agreement. - The helicase-primase inhibition mechanism targets an essential viral enzyme complex with no host equivalent, potentially offering superior efficacy to current nucleoside analog treatments.
- Assembly Biosciences reported positive Phase 1b results for ABI-4334, a next-generation capsid assembly modulator, showing potent antiviral activity against chronic hepatitis B virus infection. - The 400 mg dose cohort demonstrated mean HBV DNA reductions of 3.2 log10 IU/mL over 28 days, consistent with the 150 mg cohort's 2.9 log10 IU/mL reduction. - ABI-4334 maintained a favorable safety profile with once-daily oral dosing supported by pharmacokinetic data across both dose levels. - The trial completion triggers Gilead Sciences' option to license ABI-4334 for further development under their existing collaboration agreement.
- The U.S. FDA granted Breakthrough Therapy designation to brelovitug from Bluejay Therapeutics in January 2025, accelerating development for this investigational hepatitis D treatment. - Vir Biotechnology's combination therapy tobevibart and elebsiran received both FDA Breakthrough Therapy and EMA PRIME designations in December 2024. - The SOLSTICE Phase 2 trial demonstrated that tobevibart achieved 100% virologic response with 80% of participants reaching undetectable HDV RNA levels by Week 60. - Over 8 pharmaceutical companies are actively developing 10+ pipeline therapies for hepatitis D, addressing significant unmet medical needs in this severe liver condition.
- Assembly Biosciences has dosed the first participant in a Phase 1a trial of ABI-6250, potentially the first oral therapy for chronic hepatitis delta virus infection. - The study will evaluate safety, pharmacokinetics, and target engagement through serum bile acid measurements in healthy participants, with data expected in Q3 2025. - ABI-6250 has shown promising preclinical results with low nanomolar potency across multiple HDV genotypes and potential for once-daily oral dosing.
- Assembly Biosciences reports positive Phase 1a results for ABI-5366, an HSV helicase-primase inhibitor, showing a favorable safety profile. - The drug exhibits an approximate 20-day half-life, supporting potential once-weekly or once-monthly oral dosing regimens. - Phase 1b screening is underway to assess ABI-5366's efficacy in participants with recurrent genital herpes, with interim results expected in H1 2025.
