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Assembly Biosciences Updates Pipeline Strategy, Focusing on Finite and Curative Therapies for Chronic Hepatitis B Virus Infection
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February 25, 2021 16:00 ET | Source: Assembly Biosciences, Inc.
- Prioritizing next generation, more potent core inhibitors, triple combinations with complementary mechanisms of action, and expanding research programs to advance multiple candidates against novel targets
- Extends cash runway into 2023
- Company to host conference call today at 5:00 p.m. ET/2:00 p.m. PT
SOUTH SAN FRANCISCO, Calif., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV), today announced that it is foregoing its plans to initiate Phase 3 registrational studies of vebicorvir (VBR, or ABI-H0731) as a chronic suppressive therapy (CST) to concentrate its research and development efforts on finite and curative HBV therapies. As part of this focused strategy on finite and curative HBV therapies, Assembly Bio will prioritize its portfolio of potent next generation core inhibitors and combinations of VBR with complementary mechanisms of action, and plans to rapidly advance multiple research programs focused on novel targets and new mechanisms to the clinic.
The decision to not initiate the global registrational studies of VBR as CST followed extensive discussions with leading experts in the field and regulatory agencies, and with respect to the China territory, discussions and agreement with the company’s partner, BeiGene, Ltd. By redirecting the company’s resources previously reserved for the CST registrational studies and other activities to concentrate fully on pursuing finite and curative therapies, Assembly Bio expects to be able to advance these initiatives faster, while simultaneously extending its cash runway into 2023
“Many of us at Assembly Bio have spent our careers developing drugs aimed at addressing tremendous unmet needs in viral diseases and making a marked difference in patients’ lives. We remain committed to the vision of freeing HBV patients from a lifetime of treatment by advancing finite duration and curative therapies, and we continue to believe that core inhibitors will be a central component of these future regimens,” said John McHutchison, AO, MD, Chief Executive Officer and President at Assembly Bio. “We have the right team and resources in place to advance these efforts, and we are excited about the opportunity before us.”
“Both of our companies are committed to addressing the highest unmet medical need of patients,” said John Oyler, Chairman, Co-Founder and Chief Executive Officer at BeiGene. “We support Assembly Bio’s focus on pursuing a cure for HBV, and are hopeful that the Assembly Bio team and their portfolio of core inhibitors will bring finite and curative therapies closer to reality for the nearly 90 million HBV patients in China.”
Assembly Bio’s HBV pipeline includes three clinical-stage core inhibitor candidates and multiple research and discovery programs. The company has two clinical studies underway with one more study expected to begin during the first half of 2021.
Potent Next Generation Core Inhibitors
ABI-H2158 (2158):
Phase 2 study is ongoing with interim data anticipated in the second half of 2021.
Potent antiviral activity and a favorable safety profile has been demonstrated in a Phase 1b study.
Candidate is ~10-fold more potent than VBR in vitro against the formation of new cccDNA.
ABI-H3733 (3733):
Phase 1a study completed in healthy subjects.
Fourth Core Inhibitor Candidate:
New candidate on track to be nominated during the first half of 2021 with a potential best-in-class profile, including greater potency against cccDNA formation.
VBR + Nucleos(t)ide Analogue Reverse Transcriptase Inhibitor (NrtI) in Combination with Other Complementary Mechanisms
VBR + NrtI + interferon (peg-IFNα):
Phase 2a triple combination study has been initiated.
VBR + NrtI + RNAi:
Phase 2a triple combination study including Arbutus’ RNAi therapeutic AB-729 is expected to initiate in the first half of 2021.
Additional Combinations:
Further potential combination studies are under review to build upon the VBR + NrtI antiviral “backbone” by evaluating the addition of one or more complementary mechanisms of action.
Research Programs on New Targets
Core Protein cccDNA Disruptors:
A collaboration with Door Pharmaceuticals is underway to discover and develop a novel class of HBV cccDNA disruptors that target different phases of the HBV replication cycle distinct from and complementary to those targeted by Assembly Bio’s existing pipeline compounds.
Novel HBV Targets:
Assembly Bio has two additional internal programs underway evaluating differentiated and undisclosed targets.
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发表于 2021-2-26 13:16
