NanoViricides, a Shelton-based company, indicated this week its anti-COVID medication candidate would come in a variety of forms, from gummies to inhalants.
The company indicated Monday it is completing an Investigators Medicinal Product Dossier, which is required for its clinical trial application for its lead drug candidate against COVID-19, called NV-CoV-2.
NanoViricides previously indicated that it has shown to be “highly effective” against the virus in pre-clinical laboratory studies. According to the company, it also has “pan-coronavirus activity,” suggesting it would be effective against emerging variants.
The company also indicated it has sufficient funds for Phase I/II human clinical trials.
NanoViricides has developed NV-CoV-2 to be given to patients in multiple ways, including oral gummies, which it says may be more suitable for children and the elderly, or those who have trouble swallowing pills. These would be manufactured and made available in blister packs.
Also, an NV-CoV-2 oral syrup will be made available in sealed plastic bottles for the clinical trial. NanoViricides indicated it would make the syrup available in single-use doses once the proper dosage is finalized via the clinical trials.
The company indicated it has also developed NV-CoV-2 formulations for injection, infusion and direct lung inhalation. The inhalation formulation would particularly be beneficial to severely ill patients, as it would deliver higher levels of drug directly to the lungs, according to the company.
The company’s timeline for pursuing required drug approvals remains unclear.
NanoViricides indicated this week it “cannot project an exact date for filing” its investigational new drug application with the U.S. Food & Drug Administration, citing the company’s dependence on external collaborators and consultants.
It is currently working to complete the application, and is pursuing two drug candidates for treating COVID-19.
NV-CoV-2 is its candidate that does not encapsulate the FDA-approved antiviral medication remdesivir, which was developed by Gilead Sciences. NV-CoV-2-R is NanoViricides’ drug candidate that is made up of NV-CoV-2 with remdesivir encapsulated in it, according to the company.
Remdesivir has been widely used in hospitals to treat patients with COVID-19, including in the Yale New Haven Health system.
NanoViricides’ stock was trading Wednesday afternoon at $1.56 per share, down from a 52-week high of $7.86.
Contact Michelle Tuccitto Sullo at msullo@newhavenbiz.com.
