SHELTON, CO / ACCESSWIRE / July 6, 2023 / NanoViricides, Inc. (NYSE American:NNVC) (the “Firm”) experiences that the clinical trial of its gigantic-spectrum antiviral drug NV-CoV-2 is progressing satisfactorily.
NanoViricides is a clinical-stage global leader within the advance of extremely effective antiviral therapies according to a unique nanomedicines platform. NV-CoV-2 (API NV-387), our lead drug candidate for the therapy of coronavirus infections including COVID and doubtlessly many conditions of long COVID, is in Phase1a/1b Security and Preliminary Efficacy Human Clinical Trials initiated by the Drug Sponsor Karveer Meditech Pvt. Ltd. India, the Firm’s Licensee and co-developer in India.
Following safety and tolerability evaluate in wholesome persons for a single escalating dose of NV-CoV-2 Oral Syrup or NV-CoV-2 Oral Gummies within the Section 1a, the clinical trial will continue into Section 1b if there are no serious detrimental events.
Section 1a is Progressing Swiftly:
Enrollment within the third and top possible single dose diploma of 40mg/Kg NV-CoV-2 Oral Syrup, and one by one, 2,000mg NV-CoV-2 Oral Gummy has already begun. The bottom dose cohorts within the clinical trial (10mg/Kg Oral Syrup, and one by one, 500mg Gummy) own achieved, and the heart dose cohorts (20mg/Kg Oral Syrup, and one by one, 1000mg Gummy) had been considerably achieved allowing the top possible dose cohorts to inaugurate. Each one after dosing is under commentary (in-sanatorium discontinuance) for forty eight hrs, followed by a scheduled notify-up proceed to.
There had been no detrimental events to this level at any of the dose ranges including the top possible dosages.
Section 1b to Commence Rapidly:
In Section 1b, wholesome persons will be dosed with extra than one doses of the Oral Syrup and one by one, Oral Gummies to peek Security and Tolerability.
Additionally, in Section 1b, in separate cohorts, patients with soft to practical/severe COVID-19 can be enrolled to evaluate indication of efficacy. Sufferers deemed by the doctor to be more possible to require hospitalization interior forty eight hrs of screening will be excluded.
“We are happy with the success of the clinical trial to this level and plight ahead to the inaugurate of the Section 1b part soon,” said Anil R. Diwan, Ph.D., President and Executive Chairman of the Firm, explaining, “This clinical trial we think will be a springboard for NV-CoV-2 to delivery into extra than one antiviral indications within the end to future. NV-387 is designed as a bio-mimetic that can presumably be an effective drug in opposition to many viruses including the coronaviruses. If a success, it is poised to meet many as but unmet medical wants for the worldwide inhabitants, no longer lawful restricted to COVID.”
“Resistance is Futile”: NV-387, the provocative pharmaceutical ingredient of NV-CoV-2 is designed to mimic a cell membrane with a replacement of so known as “attachment receptor websites” chemically covalently linked to each and each polymer chain within the nanomicelle. In spite of how essential a scourge changes, it quiet binds to the identical attachment receptor(s), and therefore, it is rarely going to flee the nanoviricide drug.
This design we think solves the predominant scenario of little molecule as successfully as antibody therapeutics, namely, vogue of resistant virus variants.
NV-CoV-2 is Aimed at Satisfying Many Unmet medical Needs in COVID: NV-CoV-2 became as soon as confirmed to be extraordinarily safe in pre-clinical animal learn. It became as soon as also realized to be extraordinarily effective in lethal an infection animal model learn.
Thus we think that NV-CoV-2 will be useable in all segments of patient populations, (i) in age from pediatric to geriatric, with in another case wholesome adults incorporated; (ii) with or without co-morbidities; (iii) with disease manifestation from soft, practical, severe to hospitalized stage.
In distinction, present COVID therapeutics are restricted within the treatable segment(s) of inhabitants; thus, Remdesivir is indicated for hospitalized patients fully; Molnupiravir and Paxlovid are both indicated for patients over 65 years of age with co-morbidities that are no longer taking diversified medication that might perchance presumably perchance field off interactions. This leaves an infinite patient inhabitants that is unserved.
Further, we think that NV-387 might perchance presumably perchance fair change into a basically essential drug for the therapy of positive conditions of long COVID whereby residual virus is identified to be repeat.
NV-387 Can even Delight in a Very Extensive Vary of Indications, due to the Over 90% of All Human Viruses Use the Attachment Receptor(s) Mimicked by NV-387:
NV-387, the provocative pharmaceutical ingredient of NV-CoV-2, mimics a family of attachment receptors known as sulfated proteoglycans (S-PG), or glycosaminoglycans (GAGs). This family entails heparan sulfate (HSPG), dermatan sulfate (DSPG), chondroitin sulfate (CSPG), and keratan sulfate (CSPG). Over 90% of identified pathogenic viruses bind to at least one or extra of these attachment receptors. These viruses consist of 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 more possible to be effective as a clinically viable drug candidate in opposition to at the least all these viruses, we think. A bunch of these viruses own no readily accessible antivirals or own antivirals with restricted applicability.
Now we own already undertaken a program to amplify the skill indications of NV-387. Success in any of these learn would enable notify entry into Section II/III clinical trials for that indication.
Such enlargement of use of NV-387 would an extraordinarily good deal amplify the market size and considerably reinforce the return on investments (ROI).
On June 29, 2023, we reported that the Section 1a/1b human clinical trials referenced above started on June 17,, 2023. The crew at the support of the clinical trials became as soon as also described therein.
NanoViricides, Inc. (the “Firm”) (www.nanoviricides.com) is a clinical stage company that is developing special motive nanomaterials for antiviral therapy. The Firm’s unique nanoviricide® class of drug candidates are designed to particularly attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-CoV-2 for the therapy of COVID precipitated by SARS-CoV-2 coronavirus. Our diversified developed candidate is NV-HHV-1 for the therapy of Shingles. The Firm cannot project right dates for the regulatory activities in progressing its drug candidates due to the of the Firm’s essential dependence on external collaborators and consultants. The Firm is at this time taking into consideration advancing NV-CoV-2 through Section I/II human clinical trials.
NV-CoV-2 is the Firm’s nanoviricide drug candidate for COVID. NV-CoV-2-R is one more drug candidate for COVID that is made up of NV-CoV-2 with Remdesivir, an already authorised drug, encapsulated interior its polymeric micelles. Remdesivir is developed by Gilead. The Firm has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.
The Firm can be developing a huge pipeline of substances in opposition to a replacement of viruses, with preclinical safety and effectiveness successes achieved already in many conditions. NanoViricides’ platform technology and programs are according to the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a world unfamiliar perpetual license to this technology for several medication with explicit concentrated on mechanisms for the therapy of the next human viral ailments: 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 Rooster Flu Virus, Dengue viruses, Eastern Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and positive Coronaviruses. The Firm intends to assemble a license for poxviruses, enteroviruses, and diversified viruses that it engages into learn for, if the initial learn is a success. TheraCour has no longer denied any licenses requested by the Firm to this level. The Firm’s industry model is according to licensing technology from TheraCour Pharma Inc. for explicit utility verticals of explicit viruses, as established at its basis in 2005.
This press delivery contains ahead-taking a survey statements that deem the Firm’s present expectation referring to future events. Staunch events might perchance presumably perchance differ materially and considerably from those projected herein and rely on a replacement of things. Dash statements in this delivery, and diversified written or oral statements made by NanoViricides, Inc. are “ahead-taking a survey statements” within the course of the which draw of Fragment 27A of the Securities Act of 1933 and Fragment 21E of the Securities Alternate Act of 1934. It’s top to not teach undue reliance on ahead-taking a survey statements since they involve identified and unknown risks, uncertainties and diversified components that are, in some conditions, past the Firm’s support a watch on and that might perchance presumably perchance, and proceed will, materially affect right outcomes, ranges of job, performance or achievements. The Firm assumes no duty to publicly exchange or revise these ahead-taking a survey statements for any motive, or to interchange the explanations right outcomes might perchance presumably perchance differ materially from those anticipated in these ahead-taking a survey statements, although recent files turns into readily accessible in some unspecified time in the future. Vital components that might perchance presumably perchance field off right outcomes to vary materially from the corporate’s expectations consist of, but are no longer restricted to, those components that are disclosed under the heading “Likelihood Components” and in diversified areas in documents filed by the corporate on occasion with the US Securities and Alternate Commission and diversified regulatory authorities. Even supposing it is rarely that you just might perchance presumably perchance presumably think of to predict or establish all such components, they would presumably perchance fair consist of the next: demonstration and proof of conception in preclinical trials that a nanoviricide is safe and effective; a success vogue of our product candidates; our ability to peep and assemble regulatory approvals, including with appreciate to the indicators we’re searching out; the a success commercialization of our product candidates; and market acceptance of our merchandise. In explicit, as is long-established, the Firm must teach the possibility aspect that the drag to traditional drug vogue of any pharmaceutical product is amazingly prolonged and requires immense capital. As with every drug vogue efforts by any company, there can be no assurance at the present that any of the Firm’s pharmaceutical candidates would express ample effectiveness and safety in human clinical trials to consequence in a a success pharmaceutical product, including our coronavirus drug vogue program.
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SOURCE: NanoViricides, Inc.