NanoViricides (NNVC) Accelerates MPox Drug Development, Citing Strong Business and Public Health Case
NanoViricides, Inc. (NYSE Amer.: NNVC), a clinical-stage biopharmaceutical company and a pioneer in broad-spectrum antivirals, announced today its accelerated plans to advance its lead drug candidate, NV-387, into Phase II clinical trials for MPox. This strategic decision positions the company to potentially bring a much-needed antiviral to market faster, addressing a critical global health need while also paving the way for further pipeline development.
NanoViricides highlighted several key reasons for prioritizing MPox as the first indication for NV-387’s Phase II development, even with strong efficacy data in animal studies for other major viral threats like RSV, Influenza, and COVID.
Strategic Advantages of the MPox Focus
The company believes its focus on MPox offers significant advantages:
Urgent Need and Timely Trial Completion: With a continuing MPox epidemic in the African Region, there’s a pressing demand for effective treatments. This also facilitates patient recruitment, enabling a more rapid completion of the clinical trial.
Cost-Effectiveness: Conducting clinical trials in the African Region is substantially more economical compared to the US or Europe, allowing NanoViricides to optimize its research budget.
Validation of Animal Model Data: A successful Phase II trial for MPox in humans would validate the company’s use of lethal challenge animal models. This is a critical point, as NanoViricides’ animal studies have consistently shown NV-387 to be significantly superior to existing drugs across all tested infections.
Strong Financial and Public Health Case: The recent failure of tecovirimat (Tpoxx) in MPox clinical trials creates a clear void in the US Strategic National Stockpile (SNS) for effective antivirals against orthopoxviruses like MPox and Smallpox. Both tecovirimat and brincidofovir (Tembexa), currently approved for Smallpox under the “FDA Animal Rule,” have shown limitations. Brincidofovir failed due to liver toxicity, and tecovirimat demonstrated no superiority over standard care. NanoViricides believes NV-387 could become a crucial addition to the SNS, potentially securing substantial initial acquisition contracts.
Addressing a Critical Vulnerability: Unlike small chemical drugs that viruses can readily escape through mutations, NanoViricides’ host-mimetic nanomedicine technology is designed to make it difficult for viruses to develop resistance. This is particularly important for bioterrorism readiness, as manipulated forms of viruses like Smallpox could be engineered to resist conventional treatments. The company emphasizes the strong case for the US Department of Health and Human Services (HHS) to support NV-387 development for bioterrorism preparedness.
Innovative Drug Delivery
Adding to its strategic advantages, NV-387 will be administered as “NV-387 Oral Gummies.” This soft solid formulation is designed to dissolve naturally in the oral cavity, eliminating the need for swallowing pills or capsules. This is a significant benefit for MPox patients who often suffer from painful oral lesions, making swallowing difficult.
Addressing the Broader MPox Threat
The ongoing MPox epidemic in the Democratic Republic of Congo (DRC) is driven by Clade 1a and the more transmissible Clade 1b subtypes, which have higher case fatality rates than the Clade 2b circulating in the Western world. While sporadic Clade 1 cases have been reported in the USA without further spread, the potential for a larger epidemic cannot be ignored. NanoViricides asserts that readiness with an effective drug against Clade 1 MPox is crucial for national health security.
NanoViricides, Inc. is a publicly traded clinical-stage company focused on creating special purpose nanomaterials for antiviral therapy. The company’s innovative nanoviricide™ class of drug candidates is based on technology and proprietary know-how from TheraCour Pharma, Inc.
Other notable stocks to keep on top of radar include Summit Therapeutics (SMMT), Regulus Therapeutics (RGLS), Vigil Neuroscience (VIGL), Alaunos Therapeutics (TCRT), CervoMed Inc. (CRVO), Niagen Bioscience (NAGE) and Beam Therapeutics (BEAM).
Source: https://finance.yahoo.com/news/strong-business-case-phase-ii-103000363.html
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