- NanoViricides (NNVC, Financial) is nearing completion of its adaptive clinical trial design for MPox treatment using NV-387.
- The trial will involve 80 patients in the Democratic Republic of Congo across two phases.
- NV-387 aims to be the first effective treatment for MPox in human clinical trials.
NanoViricides, Inc. (NNVC) has announced substantial progress in the development of an adaptive clinical trial protocol for NV-387, its new broad-spectrum antiviral drug aimed at treating MPox Virus Clade Ia and Ib infections. This trial design is nearly complete and is poised to advance the potential first effective MPox treatment option for humans.
The clinical trial will be conducted in two parts, involving approximately 80 patients in the Democratic Republic of Congo. Phase IIa will include 20 patients equally divided between treatment and control groups, while Phase IIb will expand to 60 patients, using a 2:1 randomization—40 in treatment and 20 in the control group. Importantly, the trial will utilize NV-387 Oral Gummies, offering a patient-friendly formulation for those with mucosal lesions who find swallowing difficult.
NV-387's successful trial could mark a significant milestone as the first efficacious drug for MPox treatment in human clinical trials. NanoViricides plans to seek regulatory approvals in Africa, followed by the USA and EU, where it could receive Orphan Drug Designation. The market opportunity for NV-387 is substantial, as evidenced by SIGA's Tecovirimat generating over $600 million in US government sales through December 2024.
This strategic development positions NanoViricides favorably to capture a significant share of the orthopoxvirus treatment market, particularly as current alternatives face limitations in effectiveness or safety. The focus on more virulent Clade 1 variants, prevalent in Africa, further underscores the drug's potential impact in global healthcare.
