Catalent will supply development services for an intranasal formulation of Novan’s berdazimer sodium for COVID-19, the companies said. Berdazimer sodium is a nitric oxide-releasing polymer based on Novan’s Nitricil platform, and the company is developing topical gel formulations for the treatment of viral dermatological infections, including molluscum and genital warts.
According to the announcement, in vitro testing has found that once daily berdazimer sodium at concentrations down to 0.75 mg/mL was able to reduce SARS-CoV-2 by 90%. Novan says that it plans to submit an IND with the expectation of initiating the first clinical trial in the second half of 2021, “subject to obtaining additional funding.”
Novan President and CEO Paula Brown Stafford said, “We are pleased to be working with Catalent and to benefit from its expertise in drug development and manufacturing, which is of particular interest to us in our COVID-19 program. We look forward to advancing into preclinical IND-enabling studies and taking another step towards unlocking the potential of our proprietary nitric oxide-based medicines.”
Catalent President of Oral & Specialty Delivery Jonathan Arnold commented, “This is a tremendous opportunity for Catalent and Novan. We are proud to leverage Catalent’s broad knowledge and expertise in formulation and inhalation technologies to help address the pressing needs associated with the COVID-19 pandemic.”
Read the Catalent and Novan press release.
