First Human Clinical Trials Of A Potentially “Game-Changing Broad Spectrum Antiviral” Are Progressing Successfully – Drug Could Treat COVID, RSV And Many Other Respiratory Viruses
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September 19, 2023 09:25 AM Eastern Daylight Time
By Rachael Green, Benzinga
As COVID cases begin to rise again, heralding the beginning of another COVID wave, new variants have appeared leading this wave. EG.5 (“Eris”) is currently in the majority in the U.S.A, but a very different variant, BA.2.86 (“Pirola”) is already rising in the number of cases. BA.2.86 carries more than 30 changes in its spike protein, as well as changes in other proteins.
Scientists believe it is questionable whether the newest booster vaccine shots would be effective for this one. The newest vaccines are “single-agent” targeting the XBB variant. It is not known how effective the approved drugs (mainly Paxlovid - Pfizer Inc. (NYSE: PFE)) would be against this new variant, and further on, as the virus keeps changing. It is now clear that the SARS-CoV-2 virus is here to stay, and that it will keep changing as it continues to learn to avoid vaccines and antibodies and our own immune systems and continues to learn to resist existing old-fashioned drugs. Even without new variants, for clinically vulnerable patients COVID has always continued to be a terrifying reality.
In light of this, the broad-spectrum antiviral that is based on a novel nanomedicines platform being developed by one emerging drug company could be promising.
NanoViricides, Inc (NYSE American: NNVC) announced that it has made progress on its Phase 1a/1b clinical trial of NV-CoV-2, a novel antiviral drug candidate that has the potential to treat all strains of the coronavirus. The clinical-stage biotech reported that the safety and tolerability parts of the trial testing the antiviral in healthy subjects is nearly complete and it’s now preparing for the efficacy and dose optimization part of the trial with COVID patients.
NanoViricides Broad Spectrum Antiviral Could Change How We Treat Viral Infections
So far, NanoViricides has built a robust foundation of promising preclinical research that demonstrates the unique antiviral platform’s potential to treat not just COVID-19 but a wide range of other common and hard-to-treat viral diseases like other coronaviruses, RSV, shingles, herpes, rabies and the flu.
The reason it could have such broad applicability is because the NanoViricides platform was specifically designed to target a particular binding site that’s common across many viruses and doesn’t change even as a virus mutates. Essentially, the nanoviricide platform mimics the binding site on a human cell that a virus would normally target in order to infect that cell. Then it seeks out the virus and when the virus binds to the nanoviricide instead, the drug candidate immediately engulfs the virus, where it’s unable to infect the patient’s cells or reproduce.
The First Of These Drugs Is Now In Human Phase 1a And 1b Clinical Trials
The Phase 1a/1b clinical trial includes single-ascending dose (SAD) and multiple-ascending dose (MAD) safety and tolerability studies in healthy subjects. NanoViricides reported that 26 of the 36 volunteers in the SAD study and 17 of the 36 volunteers in the MAD study have already completed the program. And so far, the early data looks promising. Neither adverse events nor serious adverse events have been found to date in either study.
"The excellent safety and tolerability of NV-CoV-2 in both formulations in the clinical trials is consistent with the results of pre-clinical animal studies, giving us confidence that our preclinical animal studies can be expected to be predictive of human clinical trials,” said NanoViricides Executive Chairman and President, Anil R. Diwan, Ph.D.
Ongoing Phase 1a And 1b Clinical Trials Will Give First Indication Of Nanoviricides Efficacy In Humans
With that baseline of safety and tolerability, the next part of the trial is to enroll COVID patients in the trial and start evaluating whether the positive preclinical effectiveness results for the drug will translate to human trials. Once this trial is finished, NanoViricides plans to seek permission to move into phase 2 clinical trials from multiple regulatory agencies worldwide.
Of note, the same drug was found to be effective in pre-clinical studies against another important respiratory virus, RSV. Such a broad spectrum antiviral effectiveness is reminiscent of the development of antibiotics against bacteria. This could be a game-changing development in antiviral therapeutics.
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