No adverse events were reported in any of the multiple ascending dose cohorts, confirming the excellent safety of NV-387, the active ingredient in NV-CoV-2.
NV-387 is highly active against many respiratory viruses; all tested Coronaviruses and RSV among them. NV-387 was designed to mimic the host-side feature called 'sulfated proteoglycan' ('S-PG'), presenting a biomimetic of S-PG on the surface of the nanoviricide that mimics a biological cell membrane. Over 90% of human pathogenic viruses use S-PG receptors to cause infection, and many of them are expected to be susceptible to NV-387.
NV-387 is designed to attack the viral surface and disable the virus from being able to infect cells. This is reminiscent of how antibiotics such as penicillins attack bacterial surface and dismantle the bacteria.
This ultra-broad-spectrum, cross-virus-families, antiviral activity of NV-387 is expected to revolutionize not only the treatment of viral infections but also how we respond to potential pandemics in a significantly more rapid fashion than what happened with COVID-19.
Viral variants are unlikely to escape the nanoviricide drug (i) because even as the virus mutates it still binds to the same host-side features, that the nanoviricide copies and (ii) such escape is not expected based on the extremely wide spectrum of activity of NV-387, across multiple viruses in each family and across distinct virus families.
All clinical trial subjects were held in the hospital during treatment period. All of them have been discharged and all of them have also gone through the final post-discharge follow-up visit. There were no adverse events reported during treatment or through the follow-up visit. Clinical observations during the in-hospital sequestration did not show any adverse events. No adverse events were reported from lab reports of the subjects for various blood tests, organ function tests, or ECG (heart). There were no dropouts.
These results are indicative of an excellent safety profile of NV-387. These results are consistent with the excellent safety characteristics observed for NV-387 in the pre-clinical studies.
NV-387 has been found to be non-immunogenic, non-allergenic, non-mutagenic, as well as non-genotoxic in various pre-clinical animal model studies leading to the clinical trials. No adverse effects were reported in GLP Safety-Toxicology studies in multiple animal models including non-human primates (NHP, Cynomolgus monkeys). The NOAEL (No-Observed-Adverse-Events-Level) was 1,200 mg/Kg and MTD (Maximum Tolerable Dose) was 1,500 mg/Kg in rats, which indicate excellent safety.
In contrast, most known antiviral drugs have significant dose-limiting toxicities.
The human subject pharmacokinetic (PK) plasma samples have been duly received at the GLP bioanalytical lab in the
Two different drug products, (i) NV-CoV-2 Oral Syrup, 100mg/mL, and (ii) NV-CoV-2 Oral Gummies, strengths of 500mg and 1,000 mg were in the study. There were three dosing cohorts for each of the drug products.
The Phase1a-Healthy Subjects part was a Single-Ascending-Dose trial, that was successfully completed with no adverse events found, as reported previously in a press release on
The Phase1b-Healthy Subjects part was a Multiple-Ascending-Dose trial. The dosing of NV-CoV-2 Oral Syrup was at nominal 10mg/Kg, 20mg/Kg and 40mg/Kg levels, with the first dose being double the nominal amount (a 'loading dose'). The dosing of NV-CoV-2 Oral Gummies was at nominal 500mg, 1,000mg, and 2,000mg levels, with the first dose being double the nominal amount (a 'loading dose'). In all cohorts, there was a double dose on first day, followed by single doses every 48 hours for a total of five dosing instances (i.e. 6 total nominal doses) over a period of 9 days.
The clinical trial will now undergo data-lock procedures and thereafter biostatistical analyses will be conducted. The final report will become available afterwards.
The Phase 1a/1b clinical trial is being managed by our collaborator and licensee in
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Our other advanced candidate is NV-HHV-1 for the treatment of Shingles.
The Company cannot project exact dates for the regulatory activities in progressing its drug candidates because of the Company's significant dependence on external collaborators and consultants.
The Company is currently focused on advancing NV-CoV-2 through Phase I/II clinical trials.
NV-CoV-2 is the Company's nanoviricide drug candidate for COVID. NV-CoV-2-R is another drug candidate for COVID that is made up of NV-CoV-2 with Remdesivir, an already approved drug, encapsulated within its polymeric micelles. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.
The Company is also developing a broad pipeline of drugs against a number of viruses, with preclinical safety and effectiveness successes achieved already in many cases.
Disclosure Statement
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by
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