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After announcing in January it was working on a treatment for COVID-19, Shelton’s NanoViricides Inc. on Wednesday unveiled a drug candidate that it expects to advance into human testing against the coronavirus.
The drug, NV-CoV-1-R, combines the company’s nanoviricides platform with remdesivir, a well-known anti-viral drug approved for emergency use to treat COVID-19.
The company said it is now working on performing required safety pharmacology studies that would allow it to apply to the U.S. Food & Drug Administration for permission to begin human trials.
“This is an extremely important milestone for the company,” President and Executive Chairman Anil R. Diwan said in a statement. “We look forward to rapid development of the IND (investigational new drug)-enabling core safety pharmacology studies and, thereafter, human clinical development on an accelerated timeline in these trying times of the pandemic.”
Nanoviricides are tiny particles that directly attack and disable a virus. Diwan has described the technology as a “Venus fly trap” for viruses.
According to the company, NV-CoV-1-R consists of a nanoviricide, dubbed NV-CoV-1, that shows broad-spectrum anti-coronavirus activity, combined with remdesivir encapsulated in its “belly” that can affect the ability of the virus to replicate.
The company believes the combination can make remdesivir more effective by protecting it from rapid metabolism in the body.
Meanwhile, the company said the nanoviricide itself aims to attack the virus particles, and also may “possibly” attack infected cells that display a coronavirus antigen known as S-protein.
“Thus the combined attack enabled by NV-CoV-1-R on the virus could prove to be a cure for the infection and the disease, provided that the necessary dosage level can be attained without undue adverse effects,” the company said in a news release.
NanoViricides was one of the first New Haven area biotechs to announce that it was working on a treatment for the disease, sending the company’s stock soaring in January.
However, some analysts have been skeptical of its ability to deliver on the drug, citing the 15-year-old company’s finances and lack of a track record in bringing any of its drugs into human trials, including those touted during past public health scares to treat diseases such as Ebola and swine flu.
The company said Wednesday it has temporarily pivoted away from its lead drug candidate, a skin cream for shingles, which it had planned to advance into human testing, so it can concentrate on the COVID treatment.
The company said it could not project when it expects to seek FDA approval for human trials on the COVID drug “because of its dependence on a number of external collaborators and consultants.”
Since remdesivir already has emergency use approval from the FDA, NanoViricides said NV-CoV-1-R is likely to be “approvable” if found safe.
Remdesivir was developed by California biopharma Gilead Sciences, but NanoViricides said it developed NV-CoV-1-R independently.
NanoViricides stock opened at $4.80 Wednesday morning, a 5.5 percent increase over Friday’s close, but down from $16.76 on January 31, its highest price so far this year. It was trading at $4.43 as of late morning Wednesday.
Contact Natalie Missakian at news@newhavenbiz.com.
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Read HereThis special edition informs and connects businesses with nonprofit organizations that are aligned with what they care about. Each nonprofit profile provides a crisp snapshot of the organization’s mission, goals, area of service, giving and volunteer opportunities and board leadership.
Hartford Business Journal provides the top coverage of news, trends, data, politics and personalities of the area’s business community. Get the news and information you need from the award-winning writers at HBJ. Don’t miss out - subscribe today.
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