SOUTH SAN FRANCISCO – Assembly Biosciences, Inc. (NASDAQ:), a biotech firm focusing on serious viral diseases, has disclosed promising interim results from a Phase 1b study of its drug candidate ABI-4334, aimed at treating chronic hepatitis B virus (HBV) infection. The study observed favorable safety and pharmacokinetic profiles, as well as significant antiviral activity in patients. The company, currently valued at $93.56 million, has demonstrated strong market performance with a 49.58% year-to-date return, according to InvestingPro data.
The first cohort of the study, which received a daily oral dose of 150 mg of ABI-4334 for 28 days, showed a mean reduction of 2.9 log10 IU/mL in HBV DNA levels. Additionally, a mean decline of 2.5 log10 U/mL in HBV RNA was noted among participants with detectable HBV RNA at baseline. These results align with the high potency of ABI-4334 seen in preclinical studies.
Safety data for participants in both the initial and ongoing cohorts indicated that ABI-4334 was well-tolerated with no serious adverse events or discontinuations due to adverse events reported. The treatment demonstrated a half-life that supports once-daily dosing and achieved plasma concentrations expected to be effective against the virus and inhibit cccDNA formation.
Enrollment for the final 400 mg dose cohort is currently in progress, with results expected in the first half of 2025. If the study concludes successfully, it will guide Assembly Biosciences and its partner Gilead Sciences, Inc. (NASDAQ:) in deciding on further development and commercialization of the drug. InvestingPro analysis indicates the company maintains a strong financial health score of 3.14 (GREAT), with analysts setting price targets between $35-36, suggesting significant upside potential. Get access to 8 more exclusive InvestingPro Tips and comprehensive financial analysis to make informed investment decisions.
ABI-4334 is still under investigation and has not received approval for use. The interim findings from the Phase 1b study are based on a press release statement and have not been independently verified. The complete data from the trial is anticipated to be presented at future scientific meetings. Additional details about the study can be found on clinicaltrials.gov with the identifier NCT06384131.
Assembly Biosciences is focused on developing treatments for herpesvirus, HBV, and hepatitis delta virus (HDV) infections. The company’s collaboration with Gilead Sciences includes financial aspects and equity investments, with Gilead holding an option for further development and commercialization of ABI-4334 post-trial. According to InvestingPro data, the company holds more cash than debt on its balance sheet and maintains strong liquidity with a current ratio of 2.36, positioning it well for continued research and development activities.
In other recent news, Assembly Biosciences has entered into an amended collaborative agreement with Gilead Sciences. The revised terms include an immediate payment of $10 million from Gilead and a restructured opt-in fee for the drug candidate ABI-6250. Concurrently, Assembly Biosciences has launched an at-the-market equity program with Jefferies LLC, providing a flexible mechanism for capital raising.
Furthermore, Gilead has exercised an option to purchase additional equity in Assembly Biosciences, acquiring 940,499 shares. Assembly Biosciences has also reported positive interim results from the Phase 1a study of its recurrent genital herpes drug candidate, ABI-5366, indicating a favorable safety profile and potential for once-weekly or once-monthly dosing schedules.
In response to these developments, several analyst firms have provided their perspectives. H.C. Wainwright maintained a neutral stance on Assembly Biosciences, Mizuho (NYSE:) Securities reiterated an Outperform rating, and Jefferies upgraded its rating from Hold to Buy. These are recent developments that investors are expected to closely monitor.
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