NanoViricides, Inc. (NYSE American: NNVC) is moving its investigational broad-spectrum antiviral drug NV-387 toward Phase II clinical trials for the treatment of measles. The company is developing a clinical trial protocol for submission to the U.S. Food and Drug Administration (FDA) through an Investigational New Drug (IND) process. This advancement is significant because it represents a potential new treatment option for a highly contagious viral disease that has seen a resurgence in the United States and internationally, despite the availability of vaccines.
NV-387 has demonstrated antiviral activity against measles in a humanized mouse model and has completed a juvenile mouse toxicity study in which no treatment-related adverse effects were observed at the highest dose tested. The drug has also completed a Phase I human safety study and is currently being evaluated in separate Phase II trials for Ebola Bundibugyo virus and mpox in the Democratic Republic of Congo. These milestones suggest that NV-387 has a favorable safety profile and broad-spectrum potential, which could streamline its development pathway for measles.
The FDA has granted NV-387 both Orphan Drug Designation and Rare Pediatric Disease Drug (RPDD) Designation for measles treatment. The RPDD designation could make NanoViricides eligible for a Priority Review Voucher following approval of a qualifying marketing application, subject to applicable requirements. This voucher, if awarded, could be sold or used to expedite the review of another drug, providing a potential financial incentive for the company. The company said the development program addresses an unmet medical need amid rising measles cases.
For investors, the progression of NV-387 into Phase II planning for measles underscores NanoViricides’ commitment to advancing its pipeline and could represent a near-term catalyst. The company’s focus on developing a broad-spectrum antiviral that can target multiple viruses, including measles, Ebola, and mpox, positions it to address emerging infectious diseases. However, NV-387 remains investigational and has not been approved for treating measles or any other viral disease, and the path to regulatory approval is lengthy and requires substantial capital.
To view the full press release, visit https://ibn.fm/lWeDl. For more information about NanoViricides, visit www.nanoviricides.com. The latest news and updates relating to NNVC are available in the company’s newsroom at https://ibn.fm/NNVC.
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