Novel Long-Acting HBV Capsid Assembly Modulators
NIAID - National Institute of Allergy and Infectious Diseases
About This Grant
ABSTRACT OF PROPOSED RESEARCH Antiviral nucleoside analogs have proven effective in treating chronic hepatitis B (CHB) and improving the survival and quality of life for those living with CHB. However, a cure remains elusive. Currently, individuals with CHB, including those co-infected with HIV, require lifelong oral medication to suppress the virus to undetectable levels. Challenges related to medical adherence and limited access to drugs persist, underscoring the need for long-acting release formulations. Capsid assembly modulators (CAMs) represent a promising class of antivirals that disrupt the HBV capsid assembly process, preventing the encapsidation of pregenomic RNA and inhibiting viral replication. Furthermore, at higher concentrations, CAMs impede the transcription and de novo formation of covalently closed circular DNA (cccDNA) in the early stages of infection. ALG-001075 is a proprietary, novel, pan-genotypic CAM with sub-nanomolar in vitro potency. Its oral prodrug, ALG-000184, is currently being evaluated in clinical trials involving individuals with CHB, where it has shown unprecedented reductions in HBV DNA, RNA, and viral antigens, as well as superior HBV DNA reduction compared to nucleoside analogs. As the active metabolite of ALG-000184, the exceptional potency, dual anti-HBV mechanism, and safety profile position ALG-001075 as a strong candidate for long-acting regimens. This study aims to develop a biodegradable and biocompatible nanoparticle (NP) injectable sterile formulation that encapsulates ALG-001075 for prolonged release. This sustained drug release can extend the dosing interval from daily to monthly or even longer, providing significant benefits for individuals living with CHB or co-infected with HIV/HBV. Enhanced drug efficacy due to improved adherence and reduced costs will be particularly beneficial in areas lacking birth dose vaccination or in low-resource settings, where HBV carrier rates are extremely high. The specific aims are: 1) To formulate and optimize an NP delivery system for ALG-001075 that achieves extended in vitro release for at least one month (R61 phase); 2) To determine the pharmacokinetics of ALG-001075 following NP delivery (R61 phase); 3) To evaluate the in vivo antiviral efficacy of long-acting ALG-001075 in HBV mouse models (R61 & R33 phases); 4) To manufacture the drug substance and drug product to facilitate toxicology studies (R33 phase); 5) To assess the in vivo safety of long-acting ALG-001075 (R33 phase). To achieve these goals, we will initially explore the encapsulation of ALG-001075 in biodegradable polymeric NPs or lipid NPs. Formulations will be evaluated in vitro to assess release kinetics and stability and in rodents to establish exposure durability and efficacy. In the R33 phase, we will utilize existing procedures for synthesizing ALG-001075 to manufacture the drug substance and prepare a long-acting formulation that can proceed to IND-enabling toxicology studies. With the IND-directed product development strategy, we anticipate that at least one NP design will meet the requirements and advance to IND filing.
Grant Summary
Novel Long-Acting HBV Capsid Assembly Modulators is a NIAID - National Institute of Allergy and Infectious Diseases grant providing up to $955K for university, nonprofit, healthcare org. Applications are due 2028-03-31 (open). Check eligibility and apply with FindGrants.
Focus Areas
Eligibility
How to Apply
Up to $955K
2028-03-31
- 1Confirm your organization is eligible for Novel Long-Acting HBV Capsid Assembly Modulators from NIAID - National Institute of Allergy and Infectious Diseases, checking organization type, location, and any population or project requirements.
- 2Gather the required documents and information, including your organization details, project plan, and budget figures.
- 3Draft your application narrative and budget addressing the funder's priorities and review criteria. FindGrants can draft each section for you to review and edit.
- 4Review every section against the requirements checklist, then export a submission-ready application pack and submit it to NIAID - National Institute of Allergy and Infectious Diseases before the deadline.
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Novel Long-Acting HBV Capsid Assembly Modulators: Frequently Asked Questions
Who is eligible for the Novel Long-Acting HBV Capsid Assembly Modulators?
Novel Long-Acting HBV Capsid Assembly Modulators is offered by NIAID - National Institute of Allergy and Infectious Diseases and is generally open to university, nonprofit, healthcare org. It is open to organizations nationwide unless the funder specifies otherwise. Review the specific eligibility terms before applying, since funders set their own requirements around organization type, location, and the population or project being served.
How much funding does the Novel Long-Acting HBV Capsid Assembly Modulators provide?
Novel Long-Acting HBV Capsid Assembly Modulators provides up to $955K per award from NIAID - National Institute of Allergy and Infectious Diseases. Actual award sizes depend on the scope of your project, available program funds, and the number of applicants, so build a budget that reflects realistic, allowable costs rather than the maximum figure.
When is the Novel Long-Acting HBV Capsid Assembly Modulators deadline?
Applications for Novel Long-Acting HBV Capsid Assembly Modulators are due 2028-03-31 (open). Because deadlines can change, verify the date with the funder, NIAID - National Institute of Allergy and Infectious Diseases, and give yourself enough time to prepare a complete, competitive application before the close date.
How do you apply for the Novel Long-Acting HBV Capsid Assembly Modulators?
To apply for Novel Long-Acting HBV Capsid Assembly Modulators, confirm your eligibility, gather the required documents, and prepare a narrative and budget that address the funder's priorities. FindGrants guides you step by step and can draft each section, then exports a submission-ready application pack for this grant from NIAID - National Institute of Allergy and Infectious Diseases.