Oak Therapeutics announces results of bioequivalence study of company’s oral dissolvable strip for TB
Results of in vivo study signifies completion of another critical milestone in company’s Phase I of NIAID contract* to develop ODS strip for anti-tuberculosis treatment option.
OXNARD, Calif., Oct. 03, 2017 -- Oak Therapeutics, a subsidiary of CURE Pharmaceutical (OTCQB:CURR), (“CURE”), a leading disruptive drug delivery technology company, has completed an in vivo study that compared the pharmacokinetics of its proprietary 300mg Isoniazid (INH) oral dissolvable strip (ODS) as an anti-tuberculosis (TB) treatment option against an existing commercial tablet. Completion of the in vivo study was a critical milestone of the Oak Therapeutics’ Small Business Innovative Research (SBIR) Contract from the National Institutes of Health/National Institute of Allergy and Infectious Diseases (NIH/NIAID) Phase I project “Oral Dissolving Strips for the Delivery of Isoniazid in Children and Adults.”
Tuberculosis is one of the deadliest diseases with one third of the world’s population infected with TB, including 480,000 cases of multidrug resistant TB. The disease is nearly always curable if patients are treated with effective, uninterrupted anti-tuberculous therapy. Adherence to treatment is critical for cure of individual patients, controlling spread of infection, and minimizing the development of drug resistance.
ODS improves adherence by creating a better patient experience. They quickly melt in the mouth releasing the medicine that is easily carried in the saliva and swallowed. There are no liquids to measure, making dosing more accurate, and the bad taste of the medicine is masked with flavors and sweeteners, making the medicine much more pleasant for patients to take.
The in vivo study in canines showed that the INH ODS candidate entered the bloodstream at a statistically similar rate to those of comparable commercial tablets.
This confirms that ODS not only provides a better experience in delivery but that they are an effective alternative to existing tablets and liquids.
“These in vivo study results represent a crucial milestone in Phase 1 of our SBIR Contract with NIAID,” said Edward Maliski, - President (pro temp) of Oak Therapeutics. “Given that we have now successfully established the technical merit, feasibility and commercial potential for the reformulation of INH as an ODS. As a result, Oak has been invited to submit a proposal for Phase II of this project, bringing us one step closer to commercializing an ODS treatment option for TB. We are excited about the possibilities this disruptive technology will have on not only treating TB, but also for other future antibiotic and pain reliever products, for which patient adherence and ease of use are challenges.”
“We are extremely encouraged by the results of this in vivo study that confirm the viability of an ODS to treat TB,” said Dr. Michael Neely, pediatric infectious disease physician, clinical pharmacologist, and co-investigator of the Oak INH ODS Contract with the NIH/NIAID. “It’s time for a profound revolution to optimize how all patients take their medications and studies like these bring us one step closer to achieving this goal.”
Oak will be submitting a Phase II project proposal to the NIAID, which will include the Company’s plan to focus on the characterization of a lead clinical INH ODS candidate and initiation of the manufacturing scale up process.
About Oak Therapeutics
Oak Therapeutics, a subsidiary of CURE Pharmaceutical, focuses on pre-natal and pediatric medicines as well as bringing life-saving medicines to developing economies. Oak Therapeutics was founded with the goal of changing the way in which quality medicines are delivered to people in need, regardless of geography or economic status.
For more information about Oak Therapeutics, please visit its website at www.oaktherapeutics.com.
About CURE Pharmaceutical
CURE Pharmaceutical is a fully integrated specialty bioscience company improving drug efficacy, safety and the patient experience with proprietary drug dosage forms and delivery systems for a broad range of molecules. CURE has an industry leading full service cGMP manufacturing facility and is a preeminent developer and manufacturer of a patented and proprietary delivery system (CureFilm™), which includes the most advanced oral thin film on the market today. CURE has developed an array of products in cutting-edge delivery platforms and partners with leading pharmaceutical companies. CURE has positioned itself in the pharmaceutical cannabis sector with partnerships in the U.S., Canada, Israel and Germany, among other markets. The Company’s mission is to improve people’s lives by redefining how medicines are delivered and experienced.
For more information about CURE Pharmaceutical, please visit its website at www.curepharmaceutical.com.
This press release contains forward-looking statements, which are subject to risks and uncertainties. All statements, other than statements of fact, including those statements with respect to the Company's business development, are forward-looking statements. Forward-looking statements speak only as of the date made and are not guarantees of future performance. We undertake no obligation to publicly update or revise any forward-looking statements.
*This project has been funded in whole or in part with Federal funds from the USC 2304(b)(2) USC 253(b)(2), National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201600034C.
Source: GLOBE NEWSWIRE