NanoViricides Inc (NYSE-A:NNVC) has announced that the clinical trial of its broad-spectrum antiviral drug, NV-CoV-2, is progressing satisfactorily. The drug is being developed as a potential treatment for coronavirus infections, including COVID-19 and long COVID.
The ongoing Phase 1a trial involves evaluating the safety and tolerability of NV-CoV-2 in healthy individuals who received escalating doses of the drug in oral syrup or gummy form. So far, there have been no serious adverse events reported at any dose level, including the highest dosages.
The company said enrollment for the highest single dose level of NV-CoV-2 Oral Syrup (40mg/Kg) and NV-CoV-2 Oral Gummy (2,000mg) has already begun. The lowest and middle dose cohorts have either completed or are nearing completion, allowing for the progression to higher doses. Each participant is closely monitored for 48 hours after dosing and attends a follow-up visit.
Following the completion of Phase 1a, Phase 1b will commence, involving multiple doses of NV-CoV-2 administered to healthy individuals to further assess safety and tolerability. Additionally, the trial will enroll patients with mild to moderate/severe COVID-19 to evaluate the drug's potential efficacy. The Phase 1a/1b clinical trials for NV-CoV-2 began on June 17, 2023.
In a statement, Dr Anil R. Diwan, president and executive chairman commented: "We are pleased with the success of the clinical trial so far and look forward to the start of the Phase 1b portion soon."
He added: "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."
The design of NV-CoV-2, with its attachment receptor sites, aims to prevent the development of resistant virus variants, unlike small molecule and antibody therapeutics. Pre-clinical animal studies demonstrated the drug's safety and effectiveness, making it suitable for a wide range of patient populations, including those with or without co-morbidities and at different stages of disease manifestation.
The company believes that NV-CoV-2 has the potential to treat cases of long COVID and could be effective against various human viruses, as over 90% of known pathogenic viruses bind to attachment receptors mimicked by NV-387. The company is actively exploring the expansion of NV-387's indications to target other viral infections.
NanoViricides is focused on advancing NV-CoV-2 through the Phase I/II trials and is also developing another candidate, NV-HHV-1, for the treatment of shingles.
Contact the author at jon.hopkins@proactiveinvestors.com