Assembly Biosciences Inc. (NASDAQ: ASMB) has announced that it will discontinue ABI-H2158 (2158) development t after observing elevated ALT levels consistent with treatment-induced hepatoxicity in its current Phase 2 study. The company will now focus on progressing several tipple combination studies and earlier pipeline candidates.
Assembly Bio halts development of 2158
CEO and President John McHutchinson said, “Patient safety is always our priority, which is why we have elected to discontinue the development of 2158. We remain committed to our pursuit of developing finite and curative therapies for individuals with chronic hepatitis B, and our strategy remains unchanged. We will continue to evaluate our core inhibitor portfolio, to ultimately choose the best and safest candidate to take forward into later stage clinical trials as we believe this mechanism will be an important and key component of future curative regimens.”
McHutchinson added, “We remain focused on expeditiously advancing our additional clinical programs, including the two ongoing Phase 2 triple combination studies, accelerating the clinical development for 3733 and 4334, and progressing additional research programs in our HBV portfolio with complementary mechanisms. And, as always, we will continue evaluating strategic opportunities to build additional value in the company’s pipeline.”
Assembly Bio to focus on other clinical programs
Beyond core inhibition, Assembly Bio will continue to build a research pipeline of programs concentrating on HBV antiviral mechanisms. The company is working on a new family of HBV core protein modulators in partnership with Door Pharma. The modulators can interfere with viral nucleic acid, which includes cccDNA transcription. In addition, the company is doing unique internal research on two additional targets.
Assembly Bio intends to be able to progress the development of its next-gen assets more swiftly by diverting resources previously allocated to the 2158 program and the Phase 2 trials while also extending its cash runway until the second half of 2023.