NanoViricides (NYSE-A:NNVC) announced that a Phase 1 trial of its investigational therapeutic NV-387 has been completed.
The company, a leader in broad-spectrum antiviral nanomedicines, is developing NV-387 as a therapeutic for respiratory viral infections.
It has been found to be active against coronavirus infection, RSV infection, and smallpox and monkeypox-related Ectromelia virus infection in animal models.
NanoViricides (NYSE-A:NNVC) said the Phase 1 trial was closed and completed in April by the Drug Sponsor, its licensee Karveer Meditech and contract research organization (CRO) PristynCR in India.
It said both the single ascending dose part of the study, Phase 1a, and the subsequent multiple ascending dose part, Phase 1b were completed with healthy subjects.
It said it chose to close the trial with the healthy subjects study completed as diligent efforts to identify suitable COVID-19 patients for the trials were met with the absence of positive cases at the clinical trial sites, despite adding a second site.
The company highlighted that there were no reported adverse effects during the trial, indicating “excellent safety” of both of the drug products used, NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies, at all dosage levels.
The CRO is currently completing the database input of all the subjects’ clinical datasets to achieve the data lock for further statistical analysis.
Further, the company said it has begun designing a Phase 2 clinical trial to evaluate NV-387 in RSV patients.
It plans to submit a pre-IND application to the US FDA to obtain input from the agency to direct its clinical trial design efforts.
It anticipates an initial Phase 2 study in adults and, if successful, a Phase 2/3 study in RSV-infected hospitalized infants and children.
Shares of the company rose 2.7% to $1.16 around midday Tuesday trading.
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