NanoViricides Says Clinical Trial Of Broad-Spectrum Antiviral Drug NV-CoV-2 Is Progressing Well - NV-CoV-2 Is Positioned To Fulfill Many Unmet Medical Needs

Author: Happy Mohamed | July 06, 2023 10:35am

NanoViricides, Inc. (NYSE American: NNVC) (the “Company”) reports that the clinical trial of its broad-spectrum antiviral drug NV-CoV-2 is progressing satisfactorily. 

NanoViricides is a clinical-stage global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform. NV-CoV-2 (API NV-387), our lead drug candidate for the treatment of coronavirus infections including COVID and potentially many cases of long COVID, is in Phase1a/1b Safety and Preliminary Efficacy Human Clinical Trials initiated by the Drug Sponsor Karveer Meditech Pvt. Ltd. India, the Company’s Licensee and co-developer in India.

Following safety and tolerability evaluation in healthy persons for a single escalating dose of NV-CoV-2 Oral Syrup or NV-CoV-2 Oral Gummies in the Part 1a, the clinical trial will continue into Part 1b if there are no serious adverse events. 

Phase 1a is Progressing Rapidly:
Enrollment in the third and highest single dose level of 40mg/Kg NV-CoV-2 Oral Syrup, and separately, 2,000mg NV-CoV-2 Oral Gummy has already begun. The lowest dose cohorts in the clinical trial (10mg/Kg Oral Syrup, and separately, 500mg Gummy) have completed, and the middle dose cohorts (20mg/Kg Oral Syrup, and separately, 1000mg Gummy) have been substantially completed allowing the highest dose cohorts to begin. Each person after dosing is under observation (in-hospital stay) for 48 hrs, followed by a scheduled follow-up visit. 

There were no adverse events to date at any of the dose levels including the highest dosages. 

Phase 1b to Begin Shortly:
In Phase 1b, healthy persons will be dosed with multiple doses of the Oral Syrup and separately, Oral Gummies to study Safety and Tolerability. 

Additionally, in Phase 1b, in separate cohorts, patients with mild to moderate/severe COVID-19 shall be enrolled to assess indication of efficacy. Patients deemed by the physician to be likely to require hospitalization within 48 hrs of screening will be excluded. 

“We are pleased with the success of the clinical trial so far and look forward to the start of the Phase 1b portion soon,” said Anil R. Diwan, Ph.D., President and Executive Chairman of the Company, explaining, “This clinical trial we believe will be a springboard for NV-CoV-2 to launch into multiple antiviral indications in the near future. NV-387 is designed as a bio-mimetic that can possibly be an effective drug against many viruses including the coronaviruses. If successful, it is poised to satisfy many as yet unmet medical needs for the global population, not just limited to COVID.” 

“Resistance is Futile”: NV-387, the active pharmaceutical ingredient of NV-CoV-2 is designed to mimic a cell membrane with a number of so called “attachment receptor sites” chemically covalently connected to each polymer chain in the nanomicelle. No matter how much a virus changes, it still binds to the same attachment receptor(s), and therefore, it is unlikely to escape the nanoviricide drug. 

This design we believe solves the major issue of small molecule as well as antibody therapeutics, namely, development of resistant virus variants. 

NV-CoV-2 is Aimed at Satisfying Many Unmet medical Needs in COVID: NV-CoV-2 was shown to be extremely safe in pre-clinical animal studies. It was also found to be extremely effective in lethal infection animal model studies. 

Thus we believe that NV-CoV-2 will be useable in all segments of patient populations, (i) in age from pediatric to geriatric, with otherwise healthy adults included; (ii) with or without co-morbidities; (iii) with disease manifestation from mild, moderate, severe to hospitalized stage. 

In contrast, existing COVID therapeutics are limited in the treatable segment(s) of population; thus, Remdesivir is indicated for hospitalized patients only; Molnupiravir and Paxlovid are both indicated for patients over 65 years of age with co-morbidities that are not taking other drugs that would cause interactions. This leaves a large patient population that is unserved. 

Further, we believe that NV-387 may become an important drug for the treatment of certain cases of long COVID wherein residual virus is known to be present. 

NV-387 May Have a Very Large Range of Indications, because Over 90% of All Human Viruses Use the Attachment Receptor(s) Mimicked by NV-387:
NV-387, the active pharmaceutical ingredient of NV-CoV-2, mimics a family of attachment receptors called sulfated proteoglycans (S-PG), or glycosaminoglycans (GAGs). This family includes heparan sulfate (HSPG), dermatan sulfate  (DSPG), chondroitin sulfate (CSPG), and keratan sulfate (CSPG). Over 90% of known pathogenic viruses bind to one or more of these attachment receptors. These viruses include Coronaviruses, Paramyxoviruses (RSV - Respiratory Syncytial Virus, and HMPV- human MetaPneumoVirus), Dengue Viruses, HerpesViruses, Human PapillomaViruses (HPV), HIV, Hendra and Nipah Viruses, Ebola and Marburg Viruses, among others. 

NV-387 is likely to be effective as a clinically viable drug candidate against at least some of these viruses, we believe. Many of these viruses have no available antivirals or have antivirals with limited applicability. 

We have already undertaken a program to expand the potential indications of NV-387. Success in any of these studies would enable direct entry into Phase II/III clinical trials for that indication. 

Such expansion of use of NV-387 would significantly expand the market size and substantially improve the return on investments (ROI).  

On June 29, 2023, we reported that the Phase 1a/1b human clinical trials referenced above began on June 17,, 2023. The team behind the clinical trials was also described therein. 

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