The US Biomedical Advanced Research and Development Authority (BARDA) has awarded Novan $7.8 million to aid the development of what the company hopes will be the first FDA-approved drug with a burn healing indication.
BARDA will provide the funding over two years to support the development of the nitric oxide advanced healing (NOAH) technology, which will include formulation work, nonclinical toxicology and proof of concept studies in models of deep partial thickness and full thickness thermal injuries.
Dr. Nathan Stasko, president of Novan, told in-Pharmatechnologist.com that unlike previous drug developers working with nitiric oxide, Novan has “overcome CMC [Chemistry, Manufacturing and Control] and other complicated manufacturing aspects that made this difficult for scalability.
“The problem is that it’s a gas and it’s a very small molecule,” Dr. Stasko said.
The Novan technology can store and release more nitric oxide than other delivery systems, which means it can create a depot that can provide a high level of total nitric oxide release and long duration release. Novan is working on producing a nitric oxide-releasing powder that can be formulated into other dosage forms, such as a topical for acute and chronic wounds.
The company’s cGMP facilities in Research Triangle Park, North Carolina, include two class 10,000 clean rooms and allows the company to develop, compound, package and release the products for Phase I and II clinical trials.
“Burns are a challenging clinical indication because the number of patients is small,” which can make clinical trial recruitment difficult, Dr. Stasko said, noting the company is working with some of the best burn centers in the US.
He also stressed the honor of partnering with BARDA and their ability to recognize underserved areas of research. The government “does have strong programs to foster innovation. It’s a big step for them and a big step for our field,” he said.