NanoViricides reports ‘progress’ on NV-CoV-2 clinical trial

NanoViricides reports that the clinical trial of its broad-spectrum antiviral drug NV-CoV-2 is progressing satisfactorily. NV-CoV-2, the company’s 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. 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 have completed, and the middle dose cohorts have been substantially completed allowing the highest dose cohorts to begin. Each person after dosing is under observation 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. 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.