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Phase II Clinical Trial of Monkeypox Treatment by NV-387 to Commence Soon, Announces NanoViricides
SHELTON, CT / ACCESS Newswire / April 1, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") today announced that a Phase II Clinical Trial of Monkeypox Treatment by NV-387 is expected to begin soon in the Democratic Republic of Congo ...
About this update from Nanoviricides, Inc.
[{"type":"text","content":"SHELTON, CT / ACCESS Newswire / April 1, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") today announced that a Phase II Clinical Trial of Monkeypox Treatment by NV-387 is expected to begin soon in the Democratic Republic of Congo (DRC).","length":263,"tagName":"p"},{"type":"text","content":"Clinical Trial Site preparations are being performed by our CRO in India, Om Sai Clinical Research Pvt. Ltd., and associates in DRC. The CRO personnel are expected to visit the Site for final preparations and for staff training in the first week of April, 2026. Enrollment and dosing of patients is expected to begin after the staff training is completed.","length":355,"tagName":"p"},{"type":"text","content":"The Company previously reported that it has received approval to start said Phase II Clinical Trial of NV-387 for the Treatment of MPox by the Regulatory Agency ACOREP of the Democratic Republic of Congo (DRC).","length":210,"tagName":"p"},{"type":"text","content":"The Phase II clinical trial will evaluate safety and effectiveness of NV-387 for the treatment of patients with MPox disease caused by hMPXV infection.","length":151,"tagName":"p"},{"type":"text","content":"MPox Clade I is endemic in DRC and all cases in the clinical trial are expected to be of the Clade I virus. The other prominent MPox virus, MPox Clade II is substantially less severe an infection than MPox Clade I.","length":214,"tagName":"p"},{"type":"text","content":""This is an important milestone in regulatory development of NV-387," said Anil R. Diwan, PhD, President and Executive Chairman of the Company.","length":153,"tagName":"p"},{"type":"text","content":"MPox is an "Orphan Disease" in the USA. NanoViricides has applied to the US FDA for Orphan Drug Designation (ODD) of NV-387 for the treatment of MPox. This ODD, assuming it is granted, would enable several benefits including frequent meetings with FDA, waiver of certain FDA fees, certain R&D credits, as well as extension in exclusivity in marketing once approved.","length":379,"tagName":"p"},{"type":"text","content":"These ODD benefits can have a positive economic impact for NanoViricides estimated in the range of tens of millions of dollars.","length":127,"tagName":"p"},{"type":"text","content":"There is no drug available for the treatment of hMPXV infection that c...