NanoViricides, Inc. has announced the progression of its broad-spectrum antiviral drug, NV-387, to Phase II clinical trials. This development marks a significant step forward in the potential treatment of multiple viral infections, including MPOX (monkeypox), respiratory syncytial virus (RSV), influenza, and COVID-19. The company's announcement follows the filing of its Q3 2024 financial results, revealing both progress and financial challenges.
Clinical Trial Progress
NV-387 has completed a Phase Ia/Ib clinical trial in healthy subjects, with no adverse events reported. This initial trial assessed the safety and tolerability of the drug, providing a foundation for further clinical development. The company is currently awaiting the final report from this Phase I trial.
Building on these results, NanoViricides is planning to initiate Phase II clinical trials for NV-387. One trial will focus on the treatment of MPox infection in Central Africa, where the MPox Clade 1/1b infection has been declared a Public Health Emergency of International Concern (PHEIC) by the World Health Organization (WHO). This clade has a substantially greater fatality rate than COVID, particularly affecting pediatric populations.
The second planned Phase II trial will investigate the use of NV-387 for the treatment of RSV infection in the USA. Pediatric RSV infection is a critical unmet medical need, representing a multi-billion-dollar market in the USA alone.
Preclinical Efficacy
Preclinical studies have demonstrated that NV-387 exhibits activity surpassing that of known agents in animal models for COVID-19, RSV, influenza, and Mpox/smallpox. Notably, NV-387 treatment potentially completely cured lethal RSV infection in mice, with indefinite survival and no lung pathology.
In comparative studies against influenza, NV-387 treatment was found to be substantially superior to three approved anti-influenza drugs: oseltamivir (Tamiflu®), peramivir (Rapivab®), and baloxavir (Xofluza®). Additionally, NV-387 demonstrated activity against lethal poxvirus infection animal models that was on par with or superior to the approved drug tecovirimat (TPOXX®).
Mechanism of Action
NV-387 operates through a unique mechanism of action, mimicking sulfated proteoglycans (S-PG) to attack virus particles. This mechanism targets the viruses' reliance on heparan sulfate proteoglycans for cell entry. This approach is expected to maintain effectiveness even as virus genomes change, reducing the likelihood of viral escape, a common problem with current antiviral treatments.
Financial Status
As of September 30, 2024, NanoViricides reported cash and cash equivalents of approximately $3.87 million, along with $7.36 million in net property and equipment assets. However, the company also reported that it does not have sufficient funding to continue operations through November 14, 2025, for its planned objectives, including the Phase II clinical trials. The company utilized approximately $2.6 million in operating activities during the reported period, including $1 million in R&D expenditures for Phase II clinical trial application preparation. NanoViricides raised approximately $1.71 million through an At-the-Market (ATM) offering and has access to a $3 million credit line from its founder.
Future Plans
NanoViricides plans to advance NV-387 into Phase II clinical trials for MPox and RSV. The company also intends to advance regulatory processes for NV-387 registration for other indications, including influenza and COVID-19, via partnerships and non-dilutive funding.
