Assembly Biosciences(US:ASMB)2021-02-28 21:57Assembly Biosciences, Inc. Hepatitis B Program Update Conference Call Summary Company Overview - Company: Assembly Biosciences, Inc. (NASDAQ: ASMB) - Focus: Development of therapies for Hepatitis B Key Points and Arguments Strategic Shift - The company has decided to focus solely on finite and curative therapies for Hepatitis B, abandoning the chronic suppressive therapy approach due to regulatory feedback and market needs [6][10][39] - Approximately 270 million people worldwide are affected by Hepatitis B, with only 5 million currently receiving treatment, indicating a significant unmet medical need [7] Research and Development Pipeline - The pipeline includes advanced core inhibitors, with vebicorvir showing promising results in Phase II trials when combined with Nuke therapy [8][12] - The company plans to initiate triple combination studies involving vebicorvir, Nuke, and interferon, aiming to enhance treatment efficacy [14][13] - A fourth-generation core inhibitor is expected to be nominated in the first half of the year, targeting improved potency and safety [17] Clinical Trials and Studies - Two Phase III registrational studies in China for chronic suppressive therapy were planned but are now on hold due to regulatory challenges [9][10] - The company is advancing a Phase II trial for 2158, a next-generation core inhibitor, with interim data expected later this year [16][31] Regulatory Insights - The FDA's feedback indicated that the majority of Hepatitis B patients are adequately served by existing therapies, leading to the decision to pivot towards curative therapies [10][39] - Discussions with BeiGene regarding the China territory also influenced the strategic shift away from chronic suppressive therapy [39][52] Future Directions - The focus will be on developing combination therapies that can achieve deeper viral suppression and potentially cure Hepatitis B [11][55] - The company is exploring additional combination studies, including RNAi therapeutics and checkpoint inhibitors, to enhance treatment efficacy [36][38] Additional Important Content - The company emphasizes the importance of inhibiting cccDNA formation as a critical mechanism for achieving a cure [42][45] - The team has extensive experience in Hepatitis B research, which is seen as a key asset in pursuing these ambitious goals [21] - The decision to focus on finite and curative therapies is viewed as a long-term effort that will require incremental progress [55] This summary encapsulates the critical updates and strategic decisions made by Assembly Biosciences regarding their Hepatitis B program, highlighting their commitment to addressing the unmet medical needs of patients through innovative therapies.