Oak Therapeutics Receives NIH SBIR Phase II Award for 3-Drug Oral Dissolvable Strip for Pediatrics

LAWRENCE, Kan. - EntSun -- Oak Therapeutics, a life sciences company headquartered in Thousand Oaks, CA, with R&D laboratories in Lawrence, KS,  announced that it has received a SBIR Phase II award from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to advance a novel three-drug Oral Dissolvable Strip (ODS) for the treatment of HIV in infants and young children.

The award provides $1.9 million for the total project, which builds on Oak's successful Phase I development of ALD-ODS, a fixed-dose combination strip containing abacavir (ABC), lamivudine (3TC), and dolutegravir (DTG). Phase I demonstrated that the three chemically different antiretroviral drugs could be incorporated into a single-layer ODS and established proof-of-concept in-vivo bioequivalence in rats.

"Children should not have to struggle with medications simply because conventional dosage forms were designed primarily for adults," said Dr. Edward Maliski, Oak Therapeutics CEO and Chief Scientific Officer. "Combining three important antiretroviral drugs into a single, small Oral Dissolvable Strip illustrates significantly simplifies HIV treatment for children and their caregivers around the world."

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ALD-ODS is designed as a ready-to-use, pleasant tasting, mucoadhesive dosage form requiring no water for administration. The Phase II program will optimize the strip's performance, conduct preclinical toxicology and pharmacokinetic bioequivalence studies, and develop a continuous manufacturing process.

Oak's proprietary ODS platform pushes the boundaries of conventional oral film technology through industry-leading drug loading, programmable dissolution and drug release from seconds to multiple hours, mucoadhesion, and customized dosing.

The HIV program follows Oak's NIH-supported work on an ODS containing 300mg of isoniazid and rifapentine for latent tuberculosis. In 2025, Oak received an NIH SBIR Phase II award to further advance that program too. Together, the TB and HIV programs demonstrate the versatility of Oak's platform across different drugs, combinations, doses, and release profiles.

"Our objective is larger than developing a single product," Maliski added. "Oak has a drug-delivery platform that can be adapted to the needs of medicines and the patient, particularly for pediatric, geriatric and other patients for whom conventional tablets, capsules, or liquides can be problematic."

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About Oak Therapeutics

Oak Therapeutics develops innovative drug-delivery technologies designed to make medicines easier to administer and more acceptable to patients. The company is headquartered in Thousand Oaks, CA, with R&D laboratories in Lawrence, KS, and specializes in proprietary Oral Dissolvable Strip technology featuring high drug loading, tailored dissolution and release, mucoadhesion, taste masking, and customized dosing for patients in different weight bands.

NIH Funding Acknowledgment

Research reported in this press release is supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number R44AI170237. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.