NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage global leader in nanomedicines against viruses, announced today that it has shipped the drug products for impending clinical trials of NV-CoV-2, its COVID drug candidate, to its collaborator, Karveer Meditech Pvt. Ltd., Kolhapur, India ("Karveer").
Karveer has already successfully obtained required regulatory permissions to conduct clinical evaluation of NV-CoV-2 as a COVID treatment in India. It has retained a well-regarded local Clinical Research Organization to conduct the NV-CoV-2 human clinical trials.
Even as U.S. President Joe Biden recently signed a resolution to end the COVID-19 emergency, SARS-CoV-2 continues to claim over 1,700 lives per week in the USA alone, in what is currently a "non-wave" period, claiming five times the number of lives taken by Influenza viruses. The SARS-CoV-2 virus with its continually evolving variants is now a continuously recurring phenomenon, like other seasonal viruses such as Influenzas.
The Company targets NV-CoV-2 to fulfill an important medical need that remains unmet even today. There is no antiviral COVID drug available yet that can be used for the treatment of all segments of patient population. Equally noteworthy, there is no antiviral COVID drug available yet that can be expected to continue to work even as new variants of the SARS-CoV-2 keep evolving and spreading in the field.
NV-CoV-2 is a broad-spectrum, pan-coronavirus drug that is unlikely to be overcome by SARS-CoV-2 variants, because of the very nature of how NV-CoV-2 is designed. It has been found to work against many unrelated coronaviruses in pre-clinical studies, supporting this expectation.
Additionally, the observed strong pre-clinical safety of NV-CoV-2 indicates that the drug would be applicable to treat disease in all populations from pediatrics to otherwise healthy adults to patients with co-morbidities. NV-CoV-2 has shown extremely strong safety in multiple pre-clinical animal models in both GLP and non-GLP studies. In particular, its extremely strong safety is seen in its NOAEL* value of 1,200 mg/Kg and MTD* value of 1,500 mg/Kg in rats. The drug was also found to be non-immunogenic and non-mutagenic. Further, there were no indications of possible allergy or injection-site reactions in any of the studies across multiple animal models.
NV-CoV-2 is expected to be available for the treatment of mild to moderate disease in two orally available forms, oral syrup and oral gummies to suit patients from pediatrics to healthy adults to patients with co-morbidities. It is expected to be available in an injectable form for the treatment of out-patients (i.e. non-hospitalized) with severe disease. It is also expected to be available in an infusion form as well as a direct lung inhalation form for the treatment of hospitalized patients with severe disease.
In contrast, currently approved antiviral drugs against SARS-CoV-2 have significant limitations on the segment of population in which they can be useful, severely restricting their applicability.
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