Earnings release
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assemblybio Assembly Biosciences Reports Third Quarter 2021 Financial Results and Recent Highlights November 4 , 2021 -- SOUTH SAN FRANCISCO , Calif . , Nov. 04 , 2021 ( GLOBE NEWSWIRE ) Assembly Biosciences , Inc. ( Nasdaq : ASMB ) , a clinical - stage biotechnology company developing innovative therapeutics targeting hepatitis B virus ( HBV ) , today reported financial results and recent highlights for the third quarter ended September 30 , 2021 . John McHutchison , AO , MD , chief executive officer and president of Assembly Bio , said , " We are excited to advance our latest core inhibitor ABI - 4334 , with a potential best - in - class profile , and we are working quickly and diligently to move this candidate into clinical development as soon as possible next year . In parallel , we have expanded evaluation of triple combination regimens to treat HBV , which include the potential backbone therapy of our lead investigational core inhibitor candidate vebicorvir ( VBR ) plus standard - of - care nucleos ( t ) ide reverse transcriptase inhibitor ( Nrtl ) therapy together with an additional complementary mechanism . Our two ongoing Phase 2 studies include interferon ( peg - IFNa ) and Arbutus ' RNAi therapeutic candidate , and we look forward to initiating a third Phase 2 , all - oral triple combination cohort with Antios ' ASPIN , ATI - 2173 . We anticipate initial data from all three of these studies during 2022. Meanwhile , we are pleased to feature our science and portfolio at scientific and clinical meetings , demonstrating our commitment to pursuing finite and curative therapies for the more than a quarter of a billion individuals living with chronic HBV infection worldwide . " Recent Updates • ABI - 4334 , a next - generation core inhibitor candidate that has been optimized for potency against the formation of cccDNA , was selected for advancement into clinical development . The company is conducting preclinical work , with the aim of completing regulatory filings and initiating a clinical study as soon as possible in 2022 . • Enrollment and dosing continue in two Phase 2 triple combination studies evaluating Assembly Bio's lead core inhibitor candidate , VBR + Nrtl therapy along with Arbutus Biopharma's RNAi therapeutic candidate , AB - 729 , and separately with peg - IFNa . • A clinical collaboration agreement was announced with Antios Therapeutics to evaluate a triple combination of VBR + Nrtl and ATI - 2173 , Antios ' investigational proprietary active site polymerase inhibitor nucleotide ( ASPIN ) in a ten patient cohort . • Further development of ABI - H2158 ( 2158 ) was discontinued following the observation of elevated alanine aminotransferase ( ALT ) levels consistent with drug - induced hepatotoxicity in a Phase 2 trial . The decision reflects the company's strategy of advancing the candidates that exhibit the strongest safety and efficacy profiles for later - stage clinical studies . • William Delaney , PhD , chief scientific officer , highlighted Assembly Bio's approach and core inhibitor portfolio during recent scientific conferences focused on HBV . • Participated in a round - table discussion during ICE - HBV : HBV Cure : The Mechanisms Behind Combination Therapies • Presented on the " Discovery and Development of Novel Inhibitors of HBV Core Protein for the Treatment for Chronic Hepatitis B " during The Science of HBV Cure Meeting 2021 Anticipated Milestones and Events • Interim on - treatment data from triple combination studies with VBR + Nrtl , and complementary mechanisms RNAi and peg - IFNa anticipated during 2022 • Initiate triple combination cohort with VBR + Nrtl and ATI - 2173 in H1 2022 with 12 - week on - treatment data expected by year - end 2022 • Initiate Phase 1b study in ABI - H3733 in 2022 • Complete regulatory filings for ABI - 4334 and initiate clinical development during 2022 Upcoming Conferences • Three abstracts , including one late - breaking submission , will be presented at the annual meeting of the American Association for the Study of Liver Diseases ( AASLD ) , The Liver Meeting Digital Experience ™ ( TLMdX ) being hosted virtually November 12-15 , 2021 • Luisa Stamm , MD , PhD , chief medical officer , will present during the International Workshop on HBV Cure 2021 , November 10 , 2021 at 11 am ET • Jefferies London Healthcare Conference . A webcast of the fireside chat will be available in the " Events and Presentations " page in the " Investors " section of the company's website at www.assemblybio.com on November 18 , 2021 at 8:00 am GMT • William Delaney , PhD , chief scientific officer , will present " Development of HBV Core Inhibitors for the treatment of Chronic