NanoViricides, Inc. (NYSE American: NNVC) is advancing its investigational broad-spectrum antiviral drug NV-387 toward Phase II clinical trials for the treatment of measles, the company announced. The clinical-stage company is developing a trial protocol for submission to the U.S. Food and Drug Administration through an Investigational New Drug process.
The move comes as measles cases are rising in the United States and internationally, underscoring an unmet medical need. NV-387 has already demonstrated antiviral activity against measles in a humanized mouse model and completed a juvenile mouse toxicity study in which no treatment-related adverse effects were observed at the highest dose tested, according to the announcement. 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.
NV-387 has received both Orphan Drug Designation and Rare Pediatric Disease Drug (RPDD) Designation from the FDA 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. Such a voucher, if granted, can be sold or used to expedite regulatory review of a future product, potentially adding value for the company.
Despite the progress, NV-387 remains investigational and has not been approved for treating measles or any other viral disease. The company noted that drug development is lengthy and requires substantial capital, and there can be no assurance that its candidates will show sufficient effectiveness and safety for human clinical development. For a full view of the press release, visit https://ibn.fm/lWeDl.
NanoViricides describes itself as a clinical-stage company creating special-purpose nanomaterials for antiviral therapy. Its lead drug candidate, NV-387, is being developed as a treatment for RSV, COVID, Long COVID, influenza and other respiratory viral infections, as well as mpox/smallpox and measles. The company’s business model is based on licensing technology from TheraCour Pharma, Inc., and it holds a worldwide exclusive perpetual license for several drugs targeting specific human viral diseases. More information about the company is available at www.nanoviricides.com.
The advancement of NV-387 into Phase II planning for measles highlights the potential of broad-spectrum antiviral platforms to address multiple public health threats. If successful, the program could provide a new option for a highly contagious disease that has seen resurgence in recent years. The news was distributed by BioMedWire, a specialized communications platform focused on biotechnology, biomedical sciences and life sciences. BioMedWire is part of the Dynamic Brand Portfolio at IBN, which provides wire solutions through InvestorWire, editorial syndication to more than 5,000 outlets, press release enhancement, social media distribution and tailored corporate communications solutions. For investors, the latest news and updates relating to NNVC are available in the company’s newsroom at https://ibn.fm/NNVC.
