Oak Therapeutics completes critical milestone in Phase I to develop oral dissolvable strip for TB

Comapny has created a novel formulation to produce a product prototype containing 300 mg of Isoniazid, that is both rapidly dissolving and mucoadhesive.

Under the Phase I contract issued to Oak by the NIAID in May 2016, Oak sought to establish the technical merit, feasibility and commercial potential for the reformulation of isoniazid, an oral antibacterial prescription medicine for the prevention and treatment of Tuberculosis, as an ODS. Oak has created a novel formulation using encapsulation technologies, suitable matrix components, flavoring ingredients and other ODS formulation parameters to produce a product prototype containing 300 mg of Isoniazid, that is both rapidly dissolving and mucoadhesive. This represents an industry-first, and a significant advance to CURE’s proprietary CureFilmTM drug delivery platform.

Patient adherence is a substantial health issue that is significantly magnified when dealing with long term treatments for diseases such as tuberculosis, the second most common infectious cause of death worldwide after HIV. A significant factor in suboptimal adherence may be the formulation of the drug. Furthermore, with Isoniazid included in the Best Practices for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics for 2015, isoniazid is an ideal candidate for reformulation as an ODS.

“The challenge was to find a way to create a strip that could deliver 300 mg of drug while still dissolving in the mouth in less than a minute. We were able to invent exactly such a disruptive technology”, said Ed Maliski, President of Oak Therapeutics.

“Having this technology creates many new opportunities for future products for other antibiotics and for pain relievers,” said Rob Davidson, CEO of CURE. “Such drugs were previously not considered because of the high dose needed.”

Oak is currently in the application process for Phase II of the SBIR program, to continue its research and development and focus on manufacturing scale up, clinical trials and commercialization.