# Novel antiretroviral therapy delivery platform for infants and young children: oral dispensable strips (ODS)

> **NIH NIH R43** · OAK THERAPEUTICS, INC. · 2022 · $216,846

## Abstract

PROJECT ABSTRACT
Between 1.3 – 2.4 million children under 15 live with HIV and are in need of regular treatment. Estimates
for HIV related deaths among children are as high as 160,00 annually and often rooted in poor patient
and caregiver adherence. Causes for poor adherence are rooted in low palatability of existing
formulations (liquids, fast-dissolving tablets), the complexity of preparation and administration, and
issues related to patient privacy / social stigma. Oak Therapeutics, Inc., is an early-stage
pharmaceutical company that specializes in formulation and manufacturing of support matrix strips
composed of oral-disintegrating polymers (ODS). The goal of this proposal is to develop dissolvable
strip (ODS) platform that supports multi-drug pediatric formulation and to commercialize the first ever
ODS formulation for pediatric antiviral therapy consisting of Abacavir/ Lamivudine/ Dolutegravir (ALD-
ODS). We have already developed ODS containing a pediatric prophylactic dose of two HIV
antiretroviral drugs (AZT and NVP) with appropriate properties for administration to infants and young
children, including muco-adhesion, rapid oral dispersion, and taste-masking. In this proposal we will
develop a novel computational method for multi- drug ODS formulation which will be used to
encapsulate and make ALD-ODS strip. Optimal ODS candidate will be compared to commercial
reference standard of treatment and analyzed in an in vivo PK/PD study to determine pharmacokinetics
and toxicology profiles. The final ALD-ODS product will be the first oral film to contain HIV combination
regiment medications. It will also be the first to achieve the targeted criteria of an orally dissolvable
product, and it will be among the first pediatric products to contain all recommended first line drugs in
a single formulation with easily modified dosing to simplify administration for caregivers.

## Key facts

- **NIH application ID:** 10483794
- **Project number:** 1R43AI170237-01
- **Recipient organization:** OAK THERAPEUTICS, INC.
- **Principal Investigator:** EDWARD G MALISKI
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $216,846
- **Award type:** 1
- **Project period:** 2022-09-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10483794

## Citation

> US National Institutes of Health, RePORTER application 10483794, Novel antiretroviral therapy delivery platform for infants and young children: oral dispensable strips (ODS) (1R43AI170237-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10483794. Licensed CC0.

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