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.
CURE Pharmaceutical's subsidiary company, Oak Therapeutics, has completed a critical milestone of its Phase I Small Business Innovative Research Contract (SBIR) from the National Institutes of Health/National Institute of Allergy and Infectious Diseases (NIH/ NIAID) to develop a formulation for 300 mg of Isoniazid in a rapidly dissolving oral dissolvable strip (ODS) as an anti-tuberculosis treatment option.
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.
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance