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Assembly Biosciences, Inc. (NASDAQ: ASMB) is a public clinical-stage biotechnology company dedicated to advancing innovative therapies for serious viral diseases. The company focuses on two key platform programs: the treatment of Hepatitis B virus (HBV) infection and the development of novel oral live biotherapeutics for disorders associated with the microbiome.
In the HBV program, Assembly Biosciences is pioneering a new class of oral therapeutics aimed at increasing cure rates for patients with chronic HBV. The company has developed several drug candidates that inhibit various steps in the HBV lifecycle, including novel core protein allosteric modulators (CpAMs). These small molecules target and modulate the HBV core protein, a crucial component in the virus's replication process.
The microbiome program is designed to address diseases linked to dysbiosis, an imbalance in the microbial community of the gut. Assembly Biosciences employs a robust strain identification and selection process, methods for strain isolation and growth under Good Manufacturing Practices (GMP), and a patent-pending delivery system known as GEMICEL®. This system ensures targeted delivery of live biotherapeutics to specific areas in the gastrointestinal tract.
Recent achievements for Assembly Biosciences include a long-term partnership with Gilead Sciences to accelerate the development of their antiviral pipeline. This collaboration is expected to enhance the company's financial and scientific resources, positioning them to achieve critical milestones and deliver innovative treatments to patients.
Financial results for the third quarter of 2023 highlighted the company's ongoing progress, including the advancement of multiple antiviral candidates targeting herpesviruses, HBV, and hepatitis delta virus (HDV). Assembly Biosciences also announced leadership enhancements, including the appointment of Dr. Anuj Gaggar as Chief Medical Officer.
Looking ahead, Assembly Biosciences plans to have four candidates in clinical studies by the end of 2024. These include the initiation of trials for ABI-5366, a long-acting herpes simplex virus helicase-primase inhibitor, and the development of ABI-6250, an orally bioavailable small molecule for treating chronic HDV.
For more information, visit assemblybio.com.
Assembly Biosciences has initiated a Phase 1a/b clinical trial for ABI-5366, a new helicase-primase inhibitor targeting herpes simplex virus (HSV). The Phase 1a trial involves single ascending doses in healthy participants, with interim data expected by Q3 2024. Phase 1b will start by the end of the year with multiple ascending weekly doses in patients with recurrent genital herpes, with interim data expected in the first half of 2025. ABI-5366 has shown strong potential in preclinical studies, potentially offering a long-acting treatment for HSV-1 and HSV-2. Existing treatments are and not fully effective, highlighting the need for new therapeutic options in this area.
Assembly Biosciences showcased new preclinical data for ABI-6250, an orally bioavailable hepatitis D virus (HDV) entry inhibitor, at the EASL Congress 2024. The data underline ABI-6250's potential to block HDV from entering cells, targeting the NTCP bile acid transporter with high selectivity. The preclinical results showed effective inhibition of HDV infection and NTCP-mediated bile acid uptake, supporting once-daily oral dosing. Clinical trials are expected to begin by the end of 2024. Chronic HDV is a severe viral hepatitis form, leading to liver complications and potential death. ABI-6250 promises to be a significant therapeutic innovation in viral hepatitis treatment.
Assembly Biosciences (Nasdaq: ASMB) will present preclinical data from its HSV and HDV therapeutics at the International Herpesvirus Workshop (July 13-17, 2024) and EASL Congress 2024 (June 5-8, 2024). Data for ABI-5366 and ABI-1179, targeting recurrent genital herpes, will be featured in one oral and two poster presentations. ABI-6250, aimed at treating chronic hepatitis D, will be presented as a poster. The company anticipates starting clinical trials for ABI-5366 mid-year and for ABI-1179 and ABI-6250 by the end of 2024.
Assembly Biosciences, Inc. (Nasdaq: ASMB) reported financial results for Q1 2024, including regulatory clearances for Phase 1 trials for ABI-5366 targeting recurrent genital herpes and ABI-4334 in chronic HBV infection. The company highlighted upcoming clinical milestones, abstract acceptance for ABI-6250 at EASL CongressTM 2024, and financial results showing $113.0 million in cash as of March 31, 2024. Revenues from collaborative research were $5.8 million, with research and development expenses at $11.9 million and a net loss of $9.1 million for Q1 2024.
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