SHELTON, CONNECTICUT – July 6, 2023 – 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.
NanoViricides, Inc. (the "Company”) (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-CoV-2 for the treatment of COVID caused by SARS-CoV-2 coronavirus. 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 human 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. NanoViricides’ platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for poxviruses, enteroviruses, and other viruses that it engages into research for, if the initial research is successful. TheraCour has not denied any licenses requested by the Company to date. The Company’s business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
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 NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond the Company's control and that could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products. In particular, as is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company’s pharmaceutical candidates would show sufficient effectiveness and safety in human clinical trials to lead to a successful pharmaceutical product, including our coronavirus drug development program.
Public Relations Contact:
Source: NanoViricides, Inc.