Nanoviricides owns a novel, multi-target, oral anti-viral platform now in clinical development. The successful completion of Phase 1 healthy participant dosing with no adverse events is a key milestone. There remains a need across many disease areas for effective antiviral therapies. The NV platform is very versatile and adaptable to different viral strains and types. Oral delivery is important for mass-market products.The NV-CoV-2 Phase I, Exhibit 1, has completed dosing of the 36 healthy participants in both single-dose (Phase 1a) and multiple-dose arms (Phase 1b). Participants received either a syrup or a gummy containing the anti-viral agent NV-387. The next stage (a continuation of Phase 1b) is to test NV-CoV-2 in 36 mild-moderate COVID-19 patients; this could happen soon. The number of COVID cases is rising in India where the Phase 1b will be run. Although reported numbers are currently low, the new SARS-CoV-2 JN.1 strain seems to be taking hold.NV-CoV-2 uses a sophisticated polymer (NV-387) to trap and disrupt viruses in the blood. The therapy aims to reduce the viral load to prevent infection of healthy cells and to enable the immune system to clear viruses rapidly. Once full Phase 1 data is available, partnering possibilities open up.A further stage of NV-CoV-2 development would be a placebo-controlled Phase 2 in a major market like the US; a US Phase 1 might be needed first. NV also plans to develop a combination therapy (NV-CoV-2-R) with remdesivir (Gilead), an approved COVID-19 anti-viral agent.NV also plans to advance NV-387 into a respiratory syncytial virus (RSV) Phase 2 study after observing preclinical “strong effectiveness”. RSV is a dangerous lung infection with no current therapies.NV has now shown in preclinical studies that NV-387 destroys a mouse pox virus (Ectromelia) related to the MPox virus. MPox (formerly called monkeypox), a zoonotic (animal) virus, can be transmitted amongst humans by contact, usually sexual. Some MPox strains can be dangerous but it has low transmissibility. There is a vaccine and a therapy, tecovirimat, but with little evidence base.
29 Jan 2024
Nanoviricides: Phase Ia/b healthy participant dosing completed; pox virus data
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Nanoviricides: Phase Ia/b healthy participant dosing completed; pox virus data
- Published:
29 Jan 2024 -
Author:
John Savin PhD MBA -
Pages:
5 -
Nanoviricides owns a novel, multi-target, oral anti-viral platform now in clinical development. The successful completion of Phase 1 healthy participant dosing with no adverse events is a key milestone. There remains a need across many disease areas for effective antiviral therapies. The NV platform is very versatile and adaptable to different viral strains and types. Oral delivery is important for mass-market products.The NV-CoV-2 Phase I, Exhibit 1, has completed dosing of the 36 healthy participants in both single-dose (Phase 1a) and multiple-dose arms (Phase 1b). Participants received either a syrup or a gummy containing the anti-viral agent NV-387. The next stage (a continuation of Phase 1b) is to test NV-CoV-2 in 36 mild-moderate COVID-19 patients; this could happen soon. The number of COVID cases is rising in India where the Phase 1b will be run. Although reported numbers are currently low, the new SARS-CoV-2 JN.1 strain seems to be taking hold.NV-CoV-2 uses a sophisticated polymer (NV-387) to trap and disrupt viruses in the blood. The therapy aims to reduce the viral load to prevent infection of healthy cells and to enable the immune system to clear viruses rapidly. Once full Phase 1 data is available, partnering possibilities open up.A further stage of NV-CoV-2 development would be a placebo-controlled Phase 2 in a major market like the US; a US Phase 1 might be needed first. NV also plans to develop a combination therapy (NV-CoV-2-R) with remdesivir (Gilead), an approved COVID-19 anti-viral agent.NV also plans to advance NV-387 into a respiratory syncytial virus (RSV) Phase 2 study after observing preclinical “strong effectiveness”. RSV is a dangerous lung infection with no current therapies.NV has now shown in preclinical studies that NV-387 destroys a mouse pox virus (Ectromelia) related to the MPox virus. MPox (formerly called monkeypox), a zoonotic (animal) virus, can be transmitted amongst humans by contact, usually sexual. Some MPox strains can be dangerous but it has low transmissibility. There is a vaccine and a therapy, tecovirimat, but with little evidence base.