NanoViricides (NYSE-A:NNVC) has reported that the Phase 1a/1b human clinical trial of its broad-spectrum antiviral drug NV-CoV-2 is progressing successfully.
According to the company’s Indian collaborator and drug sponsor, Karveer Meditech, about 26 out of the target of 36 healthy volunteers in the various cohorts in the Phase 1a Single-Ascending-Dose (SAD) have already completed the study. Additionally, 17 out of the target of 36 healthy volunteers in the various cohorts in the Phase 1b Multiple-Ascending-Dose (MAD) part of the clinical trial have already completed the study.
NanoViricides noted that no adverse events or serious adverse events were found in the SAD or MAD studies to date, in either the NV-CoV-2 Oral Syrup or the NV-CoV-2 Oral Gummies administration cohorts.
PristynCR, the company’s contract research organization (CRO) in India, has requested approval from the Ethics Committee to begin recruitment into the Phase 1b COVID Patient Treatment part of the clinical trial, based on the excellent safety and tolerability of the drug, it added.
The Phase 1b part is designed to provide initial indications of effectiveness and dose requirements.
"NV-CoV-2 can be expected to be a game-changing broad-spectrum antiviral if its effectiveness in the Covid patients in this clinical trial demonstrates results consistent with the observed extremely strong effectiveness in pre-clinical animal studies," NanoViricides executive chairman and president Dr Anil Diwan said in a statement.
"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 pre-clinical animal studies can be expected to be predictive of human clinical trials."
Covid waves
The company noted that the SARS-CoV-2 virus continues to mutate unabated, generating new variants much faster than vaccines can be developed.
While Covid waves are expected to continue because of novel variants appearing constantly, built-up immunity from prior SARS-CoV-2 exposures and infections with several variants, as well as the earlier vaccinations, means the fatality rates are expected to remain low.
It said its NV-CoV-2 antiviral addresses an unmet medical need for a broad-spectrum, safe and effective drug against multiple viral threats. The company has also announced the promising efficacy of NV-387, the active pharmaceutical ingredient of NV-COV-2, in combating Respiratory Syncytial Virus (RSV) infection in an animal model.
After the completion of this Phase 1a/1b clinical trial, it said it will be able to seek permission from multiple regulatory agencies to conduct Phase 2 clinical trials for the treatment of at least Covid and RSV, a virus particularly threatening to vulnerable infants, young children, older adults, and immunocompromised populations.
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