Between 1.3 - 2.4 million children under 15 live with HIV and are in need of regular treatment. Estimatesfor HIV related deaths among children are as high as 160,00 annually and often rooted in poor patientand caregiver adherence. Causes for poor adherence are rooted in low palatability of existingformulations (liquids, fast-dissolving tablets), the complexity of preparation and administration, andissues related to patient privacy / social stigma. Oak Therapeutics, Inc., is an early-stagepharmaceutical company that specializes in formulation and manufacturing of support matrix stripscomposed of oral-disintegrating polymers (ODS). The goal of this proposal is to develop dissolvablestrip (ODS) platform that supports multi-drug pediatric formulation and to commercialize the first everODS formulation for pediatric antiviral therapy consisting of Abacavir/ Lamivudine/ Dolutegravir (ALD-ODS). We have already developed ODS containing a pediatric prophylactic dose of two HIVantiretroviral drugs (AZT and NVP) with appropriate properties for administration to infants and youngchildren, including muco-adhesion, rapid oral dispersion, and taste-masking. In this proposal we willdevelop a novel computational method for multi- drug ODS formulation which will be used toencapsulate and make ALD-ODS strip. Optimal ODS candidate will be compared to commercialreference standard of treatment and analyzed in an in vivo PK/PD study to determine pharmacokineticsand toxicology profiles. The final ALD-ODS product will be the first oral film to contain HIV combinationregiment medications. It will also be the first to achieve the targeted criteria of an orally dissolvableproduct, and it will be among the first pediatric products to contain all recommended first line drugs ina single formulation with easily modified dosing to simplify administration for caregivers.
Public Health Relevance Statement: PROJECT NARRATIVE
Between 1.3 - 2.4 million children under 15 years of age globally live with HIV and require regular treatment.
Pediatric adherence to efficacious HIV treatments is low with current estimates for HIV related deaths among
children being as high as 160,00 annually. The overarching goal of this SBIR proposal is to develop HIV therapy
delivery platform that is simple to administer to children, easily palatable, pleasantly tasting, and discrete.
Project Terms: <3TC><15 year old><15 years of age><0-11 years old>
