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SOUTH SAN FRANCISCO, Calif. - Assembly Biosciences, Inc. (NASDAQ:ASMB), a biotechnology firm focusing on serious viral diseases, has reported positive interim results from its Phase 1a study of ABI-1179, a drug candidate for recurrent genital herpes. The study indicated that ABI-1179 is well-tolerated and has a half-life of approximately four days, suggesting the potential for once-weekly oral dosing. According to InvestingPro data, the company, currently valued at $81 million, maintains a strong financial position with more cash than debt on its balance sheet.
The company announced its intention to progress ABI-1179 directly into the Phase 1b portion of the ongoing Phase 1a/b study. This next phase will run concurrently with a similar study for another candidate, ABI-5366, with expectations to release interim data for both in fall 2025. With a healthy current ratio of 2.36 and analysts projecting sales growth, InvestingPro analysis suggests the company is well-positioned to fund its development pipeline. InvestingPro subscribers have access to 5 additional key insights about Assembly Bio’s financial health.
The Phase 1a results exceeded Assembly Bio’s targets for ABI-1179’s plasma concentrations necessary for antiviral activity, based on pharmacokinetic modeling. The company aims to improve treatment outcomes for individuals with recurrent genital herpes, a condition that has not seen new therapeutic innovation in decades.
The upcoming Phase 1b study will explore multiple ascending doses of ABI-1179 in participants with recurrent genital herpes, assessing safety, tolerability, pharmacokinetics, and antiviral activity. This includes changes in viral shedding rates and the effects on clinical parameters such as lesion recurrence rate and duration.
Assembly Biosciences highlighted the unmet need for better treatments for genital herpes, which affects millions and increases the risk of HIV acquisition. Current standards of care are only partially effective in preventing recurrences and reducing virus transmission.
The investigational products ABI-1179 and ABI-5366, contributed by Gilead Sciences, Inc. (NASDAQ:GILD) under a collaboration with Assembly Bio, have not yet been approved globally, and their safety and efficacy remain to be established.
The company plans to submit complete data from the trial for presentation at future scientific meetings. The details of the Phase 1a/b trial are available on clinicaltrials.gov under identifier NCT06698575.
This news is based on a press release statement from Assembly Biosciences. Investors tracking Assembly Bio’s progress should note that the company’s next earnings report is scheduled for March 10, 2025. For detailed financial analysis and Fair Value estimates, visit InvestingPro, where the stock is currently showing signs of being undervalued based on proprietary calculations.
In other recent news, Assembly Biosciences has reported 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 demonstrated significant antiviral activity and favorable safety profiles, with a mean reduction in HBV DNA and RNA levels among patients. Additionally, Assembly Biosciences has entered into an amended collaborative agreement with Gilead Sciences, which includes an immediate $10 million payment to Assembly and a restructured opt-in fee for the drug candidate ABI-6250. Furthermore, Gilead has increased its stake in Assembly Biosciences to 29.9% through a $20.1 million equity investment and an additional $10 million in accelerated funding. This financial boost is expected to extend Assembly’s financial runway until mid-2026, supporting the development of its antiviral pipeline. H.C. Wainwright maintained a Neutral rating on Assembly Biosciences following the interim data announcement, without setting a price target. Assembly Biosciences has also extended its sublease for office and laboratory space in South San Francisco through September 2029, securing its premises in a prime biotech location. These developments highlight Assembly Biosciences’ ongoing efforts in advancing its research and development initiatives.
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