NanoViricides' NV-387 Shows Promise Against Multiple Viral Threats Following Successful Phase I Trial
• NanoViricides has completed Phase I clinical trials for NV-387 with no reported adverse events, demonstrating potential as a broad-spectrum antiviral against MPox, RSV, influenza, and COVID-19.
• The company's novel drug candidate NV-387 showed superior efficacy compared to existing treatments for influenza and demonstrated promising results against lethal RSV infections in preclinical studies.
• NanoViricides is preparing to advance NV-387 into Phase II trials for multiple indications, including MPox infections and Viral Acute Respiratory Infections, while positioning the drug as a potential countermeasure against emerging H5N1 bird flu threats.
Japan's Controversial Approval of Tecovirimat for Mpox Treatment Despite Failed Clinical Trials
Japan's regulatory agency has approved tecovirimat (TPOXX) for mpox treatment, despite two major clinical trials showing the drug's lack of efficacy. This decision has sparked controversy among scientists, particularly following the STOMP and PALM007 trials that demonstrated no significant benefit in treating mpox patients.
Tecovirimat (TEPOXX) Approved in Japan for Orthopoxvirus Infections
• The Japan Ministry of Health, Labour and Welfare has approved tecovirimat (TEPOXX) for treating smallpox, mpox, cowpox, and smallpox vaccination complications.
• TEPOXX is the first antiviral approved in Japan for orthopoxviruses, marking a significant advancement in the nation's infectious disease preparedness.
• Approval was based on 15 clinical trials showing TEPOXX's safety and efficacy, including reduced mortality and viral load in animal studies.
• SIGA Technologies has partnered with Japan Biotechno Pharma to supply TEPOXX to Japan's national stockpile, enhancing public health security.
FDA Approves Bavarian Nordic's Vimkunya, First Chikungunya Vaccine for Adolescents
• The FDA has approved Vimkunya, a chikungunya vaccine developed by Bavarian Nordic, for individuals aged 12 and older.
• Vimkunya is the first virus-like particle (VLP) single-dose chikungunya vaccine approved in the U.S., offering a new preventative option.
• Clinical trials showed Vimkunya induced neutralizing antibodies in up to 97.8% of vaccinated individuals within 21 days.
• Commercial availability of Vimkunya in the U.S. is expected in the first half of 2025, with launches in key European markets anticipated.
Tecovirimat Fails to Improve Mpox Outcomes in NIH-Sponsored STOMP Trial
• The STOMP trial found that tecovirimat did not significantly reduce lesion resolution time or pain in adults with mild to moderate mpox.
• The Data Safety and Monitoring Board recommended halting further enrollment due to the lack of efficacy, leading NIAID to close the study.
• Tecovirimat remains available through the CDC's expanded access program for eligible patients with severe mpox or immunocompromised conditions.
• Researchers emphasize the importance of randomized clinical trials during outbreaks, despite the disappointing results for tecovirimat.
NanoViricides Advances NV-387 to Phase II Trials Targeting MPox and Respiratory Infections
• NanoViricides is set to advance its broad-spectrum antiviral candidate, NV-387, into Phase II clinical trials, focusing on MPox treatment in Central Africa.
• NV-387 demonstrated no adverse effects in Phase Ia/Ib trials, paving the way for further clinical development in viral acute respiratory infections and pediatric RSV.
• The company is also preparing NV-387 as a countermeasure against the emerging H5N1 bird flu threat, addressing limitations in current vaccines.
• NanoViricides has engaged a Clinical Research Organization (CRO) to oversee the Phase II trial for MPox, with trial sites identified in two African countries.
NanoViricides' NV-387 Advances to Phase II Clinical Trials for MPox Treatment
• NanoViricides has engaged a CRO to initiate a Phase II clinical trial for NV-387, a broad-spectrum antiviral drug.
• The trial will assess NV-387's effectiveness in treating MPox patients amidst a regional pandemic in Africa.
• NV-387 has demonstrated strong antiviral activity against orthopoxviruses in animal models, showing potential against MPox and Smallpox.
• The drug's unique mechanism mimics cell entry pathways, potentially preventing virus escape and offering a revolutionary approach.
NanoViricides' NV-387 Advances to Phase II Trials for RSV and MPOX Amid Funding Concerns
• NanoViricides' broad-spectrum antiviral NV-387 is set to advance to Phase II clinical trials for RSV and MPOX following promising preclinical results.
• A Phase Ia/Ib trial of NV-387 showed no adverse events, with the drug demonstrating superior activity against RSV, influenza, and poxviruses in animal models.
• The company faces financial uncertainty, expressing doubts about sustaining operations through September 2025 without additional funding despite recent capital raises.
• NV-387's unique mechanism, mimicking sulfated proteoglycans, aims to address viral escape, potentially revolutionizing viral infection treatment.
NIH Study Finds Siga's Tecovirimat Did Not Improve Mpox Resolution or Pain
An NIH study revealed that Siga Technologies' antiviral drug, tecovirimat, did not enhance lesion resolution time or alleviate pain in adults with mild to moderate clade II mpox and low risk of severe disease. The study's Data Safety and Monitoring Board recommended halting further enrollment due to these findings, leading to the closure of an open-label study arm for participants at elevated risk of severe disease.
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