Novan, Inc. (NASDAQ:NOVN) announced today that in vitro investigation of NITRICIL’s (berdazimer sodium) antiviral effect against SARS-CoV-2 infected 3D tissue model produced favorable results, demonstrating the potential for NITRICIL technology to effectively provide a prophylactic function against COVID-19. NITRICIL is expected to be administered via the nasal route in a gel, powder, spray, wash or other formulation yet to be determined.
The studies used a SARS-CoV-2 3D tissue model with similar structure as the respiratory tract, which is more representative of drug-virus interactions than 2D petri dish cultures. The experiment was able to demonstrate a 90% (1 log) reduction in viral output at 0.75 mg/mL of berdazimer sodium in a dose dependent relationship. Berdazimer sodium did not exhibit any cytotoxicity towards the cell and inhibited the virus.
NITRICIL is Novan’s proprietary, slow-release formulation that delivers nitric oxide to an affected area. As a small molecule, nitric oxide plays various roles in the body. One common role is in the modulation of vasodilation and constriction. But nitric oxide has other effects, including antiviral. Novan’s lead program, SB206, is pursuing treatment of molluscum contagiosum, a poxvirus, using NITRICIL technology, by applying the formulation to infected areas of the skin. The program is actively undergoing Phase III trials. Scientific literature suggests that nitric oxide may inhibit viral replication by disrupting protein function.
NITRICIL’s efficacy as an antiviral against the poxvirus warranted investigation into whether it could be effective against coronaviruses. Novan entered into a research collaboration with the Institute for Antiviral Research at Utah State University, where NITRICIL was tested, in vitro, in the Epi-airway 3D tissue model featuring differentiated normal human bronchial epithelial cells, designed to mimic the structure of human airway epithelium, the target tissue of SARS-CoV-2. The study was the first to demonstrate antiviral effect from nitric-oxide based therapy in such a model.
Results showed that concentrations as low as 0.75 mg/mL, once daily, reduced 90% of virus after repeat dosing. The results in the sophisticated model bode well for in vivo work. Novan plans next to initiate Chemistry, Manufacturing, and Controls (CMC) work with a global leader in delivery technologies and manufacturing solutions to develop an intranasal formulation for berdazimer sodium. The company further intends to continue development activities for the SARS-CoV-2 candidate and intends to submit an investigational new drug (IND) filing in 2021. Novan will also seek grants to fund the SARS-CoV-2 candidate; however, the cost of preclinical work and IND preparation is expected to be minimal relative to the overall budget.
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