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SOUTH SAN FRANCISCO, Calif. - Assembly Biosciences, Inc. (NASDAQ:ASMB), a biotechnology company with a market capitalization of $78.44 million, has announced the initiation of a Phase 1a clinical trial for ABI-6250, an investigational oral therapy for chronic hepatitis delta virus (HDV) infection. The first participant has been dosed in the trial, which aims to assess the safety, tolerability, and pharmacokinetics of the drug in healthy volunteers. According to InvestingPro data, the company maintains a strong financial position with more cash than debt and a healthy current ratio of 2.36, providing adequate resources for its clinical development programs.
The study will explore both single and multiple ascending doses of ABI-6250. It will also measure serum bile acid levels as a biomarker for the drug’s engagement with the sodium taurocholate cotransporting polypeptide (NTCP), which HDV uses to infect liver cells. Results from the study are expected to be released in Q3 2025. For investors interested in detailed analysis of biotech companies like Assembly Biosciences, InvestingPro offers comprehensive financial health scores and valuation metrics to better evaluate investment potential in this sector.
Currently, the European Union has approved one therapy for chronic HDV infection, which requires daily injections. ABI-6250 has the potential to be the first oral treatment in this category, with preclinical studies showing low nanomolar potency against multiple HDV genotypes and a pharmacokinetic profile that supports once-daily dosing.
Chronic HDV is considered the most severe form of viral hepatitis, with a high risk of progression to cirrhosis. Assembly Biosciences’ Chief Medical (TASE:BLWV) Officer, Anuj Gaggar, MD, PhD, expressed optimism about the clinical studies and the potential of ABI-6250 to simplify treatment for chronic HDV infection.
The Phase 1a study, registered as ABI-6250-101, is a randomized, blinded, and placebo-controlled trial. Participants will be assigned to receive either ABI-6250 or a placebo in up to five single-dose and five multiple-dose cohorts, with the multiple-dose cohorts undergoing repeated dosing over a 10-day period.
Assembly Biosciences is focused on developing small-molecule therapeutics for serious viral diseases, including herpesvirus, hepatitis B virus (HBV), and HDV. The company’s efforts are led by a team experienced in virologic drug development. While currently trading near its 52-week low at $12.34, InvestingPro analysis suggests the stock may be undervalued, though investors should note the company is not yet profitable, with a net loss of $40.8 million in the last twelve months.
ABI-6250 is not yet approved for use anywhere globally, and its safety and efficacy remain to be established. The information in this article is based on a press release statement from Assembly Biosciences.
In other recent news, Assembly Biosciences has reported promising interim results from its Phase 1b study of ABI-4334, a drug candidate for chronic hepatitis B virus (HBV) infection. The study demonstrated significant antiviral activity, with a mean reduction in HBV DNA levels of 2.9 log10 IU/mL and HBV RNA levels of 2.5 log10 U/mL. In another development, Assembly Biosciences announced an extension of its sublease for office and laboratory space in South San Francisco through September 2029, ensuring continuity of its operations in a prime biotech location.
Additionally, the company has progressed its herpes treatment, ABI-1179, into the Phase 1b portion of its ongoing study after positive interim results from the Phase 1a trial. Meanwhile, H.C. Wainwright has maintained a Neutral rating on Assembly Biosciences following the release of interim data from the Phase 1b study of ABI-4334. Furthermore, Assembly Biosciences has amended its collaborative agreement with Gilead Sciences (NASDAQ:GILD), receiving a $10 million payment and restructuring the opt-in fee for the development of ABI-6250.
Gilead also exercised an option to purchase additional equity in Assembly Biosciences, acquiring 940,499 shares at a premium price. These recent developments reflect Assembly Biosciences’ ongoing efforts in advancing its drug candidates and securing strategic partnerships to support its research and development initiatives.
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