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Company Overview
Assembly Biosciences, Inc. (ASMB) is a clinical-stage biotechnology company dedicated to the discovery and development of novel oral therapeutics designed to address serious viral diseases. With a dual-platform strategy focused on innovative approaches, the company is advancing a new class of oral antiviral therapeutics for hepatitis B virus (HBV) infection as well as pioneering oral live biotherapeutics aimed at restoring the health of dysbiotic microbiomes.
Innovative Therapeutic Platforms
The company’s strategic development is built on two core programs:
- HBV Therapeutics: Assembly Biosciences is developing investigational small-molecule compounds that target critical phases of the HBV lifecycle. These candidates aim to overcome the limitations of current chronic HBV treatments by targeting multiple steps in viral replication and reducing the viral reservoir, which has historically resulted in low cure rates.
- Microbiome Therapeutics: Leveraging a fully integrated platform, Assembly Biosciences has created a proprietary approach for identifying, isolating, and cultivating beneficial microbial strains. This platform, complemented by a patent-pending delivery technology, is designed to formulate oral live biotherapeutics that may address disorders associated with microbiome dysregulation.
Clinical Development and Research Focus
Assembly Biosciences operates at the forefront of antiviral drug development. Its clinical-stage programs are rigorously designed to assess safety, tolerability, and pharmacokinetics across multiple investigational candidates. The company’s robust pipeline is anchored by its commitment to advancing therapies that target the underlying mechanisms of viral infections, with research spanning from preclinical studies to early-stage clinical trials. The emphasis on oral delivery systems not only supports ease of administration but also reflects modern trends in patient-centric care.
Scientific Rationale & Differentiation
The research and development efforts are underscored by thorough mechanistic studies and innovative drug design strategies. By directly targeting key viral proteins and pathways, Assembly Biosciences aims to disrupt viral replication effectively. The incorporation of state-of-the-art strain selection methods in its microbiome program further highlights the company’s technical expertise. This combination of antiviral and microbiome-focused strategies provides a unique platform differentiating Assembly Biosciences from other entities in the competitive biotechnology landscape.
Market Position & Value Proposition
Positioned in a challenging segment of the biotechnology industry, Assembly Biosciences addresses significant unmet medical needs in the treatment of chronic viral infections. The company’s approach leverages long-standing expertise in virologic drug development and integrates rigorous clinical protocols with innovative oral delivery mechanisms. This has facilitated progress across multiple investigational therapies, which are being evaluated through well-designed clinical studies. The strategic emphasis on high-impact diseases such as HBV and conditions linked to microbiome imbalances establishes a clear value proposition to the public health sector.
Research Infrastructure and Strategic Collaborations
Assembly Biosciences benefits from an accomplished leadership team with extensive expertise in antiviral therapeutics and clinical research. Strategic collaborations with renowned partners further strengthen its research and development capabilities. This collaborative approach not only enhances the technical and clinical knowledge base but also provides a robust framework for addressing the safety and efficacy challenges associated with novel drug candidates.
Commitment to Innovation and Scientific Excellence
Underpinned by a deep commitment to scientific rigor and innovation, Assembly Biosciences continuously refines its therapeutic strategies by integrating advanced pharmacokinetic modeling, comprehensive preclinical assessments, and early-stage clinical data. The company’s methodical approach ensures that all therapeutic candidates are evaluated meticulously, thereby promoting a balanced view of potential benefits while maintaining high standards of safety and research integrity. This dedication forms the basis for sustained research excellence and positions Assembly Biosciences as a trusted informational resource in the biotechnology sector.
Assembly Biosciences (ASMB) reported its financial results for 2024, highlighting progress across its antiviral pipeline. The company ended 2024 with $112.1 million in cash, projecting operations funding into mid-2026. Revenues increased to $28.5 million from $7.2 million in 2023, while net loss decreased to $40.2 million ($6.69 per share) from $61.2 million in 2023.
Key clinical developments include positive Phase 1a interim data for ABI-1179 for recurrent genital herpes, supporting once-weekly oral dosing. The company's ABI-4334 for chronic HBV infection showed promising results with a 2.9 log10 IU/mL mean decline in HBV DNA. ASMB initiated Phase 1a study for ABI-6250 for hepatitis delta virus and advanced ABI-7423 into IND/CTA-enabling studies.
The company received a $20.1 million equity investment and $10 million in accelerated funding from Gilead Sciences to advance clinical development programs.
Assembly Biosciences (ASMB) has initiated dosing in a Phase 1a clinical trial for ABI-6250, their oral hepatitis delta virus (HDV) entry inhibitor candidate. The study will evaluate safety, tolerability, and pharmacokinetics across single and multiple ascending dose cohorts in healthy participants, with data expected in Q3 2025.
The trial will monitor serum bile acids as a biomarker of ABI-6250's engagement with its target, the NTCP transporter. Currently, only one therapy is approved for chronic HDV infection in the EU, requiring daily injections, with no approved treatments in the US.
In preclinical studies, ABI-6250 has shown low nanomolar potency across multiple HDV genotypes, selectivity for NTCP versus other bile acid transporters, and a pharmacokinetic profile supporting once-daily oral dosing. Chronic HDV is considered the most severe form of viral hepatitis, with 70% of patients progressing to cirrhosis within 10 years.
Assembly Biosciences (NASDAQ: ASMB) reported positive interim Phase 1a results for ABI-1179, their investigational long-acting herpes simplex virus (HSV) helicase-primase inhibitor for recurrent genital herpes. The drug demonstrated a favorable safety profile and approximately four-day half-life, supporting once-weekly oral dosing potential.
Key findings from the Phase 1a trial include:
- Well-tolerated safety profile across all doses (50mg, 100mg, and 300mg)
- Exceeded target plasma concentrations for antiviral activity even at lowest dose
- All treatment-emergent adverse events were mild and deemed unrelated to treatment
The company will advance directly to Phase 1b testing in participants with recurrent genital herpes, running concurrently with their ongoing Phase 1b study of ABI-5366. Interim data for both candidates is expected in fall 2025.
Assembly Biosciences (ASMB) announced interim results from its Phase 1b trial of ABI-4334, a next-generation capsid assembly modulator for chronic hepatitis B virus. The first cohort, receiving 150 mg daily oral dose, showed strong antiviral activity with a mean HBV DNA reduction of 2.9 log IU/mL over 28 days. The drug demonstrated favorable safety profile and half-life supporting once-daily dosing.
Among participants with detectable HBV RNA at baseline, a mean decline of 2.5 log10 U/mL was observed. Enrollment is ongoing for the final 400 mg cohort, with data expected in 1H 2025. Under the collaboration agreement, Gilead has the option to further develop and commercialize ABI-4334 after Phase 1b study completion.
Assembly Biosciences (ASMB) has secured a significant financial boost through a $30.1 million investment from Gilead Sciences, comprising a $20.1 million equity investment and $10 million in accelerated funding. This investment increases Gilead's ownership stake in ASMB to 29.9% and extends ASMB's cash runway to mid-2026.
The funding will support ASMB's clinical pipeline development of antiviral therapeutics targeting herpesviruses, hepatitis D virus (HDV), and hepatitis B virus (HBV). The company has initiated clinical studies for four small molecule antiviral candidates: ABI-5366, ABI-4334, ABI-1179, and ABI-6250. An interim Phase 1b proof-of-concept data readout for ABI-5366 is expected in the first half of 2025.
Assembly Biosciences (ASMB) reported Q3 2024 financial results and updates. The company announced positive Phase 1a interim data for ABI-5366, their genital herpes treatment candidate, supporting once-weekly and monthly oral dosing. Cash position was $95.0 million as of September 30, 2024, with funding projected into Q1 2026. Q3 revenue was $6.8 million from Gilead collaboration. R&D expenses increased to $13.5 million, while G&A expenses remained stable at $4.3 million. Net loss was $9.6 million ($1.51 per share), improved from $14.4 million loss in Q3 2023.
Assembly Biosciences (Nasdaq: ASMB) reported positive interim results from the Phase 1a portion of its ongoing Phase 1a/b study evaluating ABI-5366, a long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidate for recurrent genital herpes. Key findings include:
1. ABI-5366 was well-tolerated with a favorable safety profile up to 70 days of exposure.
2. Single doses surpassed target plasma concentrations for antiviral efficacy.
3. Half-life of approximately 20 days supports once-weekly or once-monthly oral dosing.
4. Both weekly and monthly dosing cohorts will be included in Phase 1b.
5. Screening for Phase 1b in participants with recurrent genital herpes has begun.
6. Interim Phase 1b results expected in the first half of 2025.
Assembly Biosciences (ASMB) reported Q2 2024 financial results and updates. Key highlights include:
- Dosing initiated in Phase 1a/b trial for ABI-5366 (genital herpes treatment) and Phase 1b trial for ABI-4334 (chronic HBV treatment)
- Two additional pipeline candidates expected to enter clinic by year-end
- Q2 revenue: $8.5 million; R&D expenses: $16.3 million; Net loss: $11.2 million ($1.98 per share)
- Cash position: $109.2 million as of June 30, 2024, projected to fund operations into Q1 2026
- Upcoming milestones: ABI-5366 Phase 1a interim data in Q3 2024, ABI-4334 Phase 1b interim data by year-end
Assembly Biosciences (Nasdaq: ASMB) presented new preclinical data on its investigational helicase-primase inhibitors for recurrent genital herpes at the International Herpesvirus Workshop. The company highlighted promising results for two candidates: ABI-5366 and ABI-1179.
Key findings for ABI-5366 include low nanomolar activity against HSV-1 and HSV-2, specificity for HSV, and a favorable safety profile. The Phase 1a/b study for ABI-5366 began in May 2024, with interim Phase 1a data expected in Q3 2024.
ABI-1179, licensed from Gilead Sciences, demonstrated potent activity against HSV strains, including acyclovir-resistant isolates, and showed potential for once-weekly oral dosing. Assembly Bio plans to initiate a Phase 1a/b study for ABI-1179 by the end of 2024.
Assembly Biosciences (Nasdaq: ASMB) has dosed the first participant in its Phase 1b clinical trial for ABI-4334, a next-generation capsid assembly modulator (CAM) targeting chronic hepatitis B virus (HBV) infection. The trial aims to evaluate the safety, pharmacokinetics, and efficacy of ABI-4334 over a 28-day period. Interim data is expected by the end of 2024. ABI-4334 has shown promising preclinical results with strong antiviral activity and is optimized to inhibit HBV DNA replication and prevent cccDNA formation. Chronic HBV is a leading cause of chronic liver disease and liver transplants, making this study important for potential therapeutic advancements.
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