Final results for VV116 (mindeudesivir hydrobromide) shows efficacy in COVID 19 trial- Junishi Biosciences

The data, which was published in The Lancet Infectious Diseases on 22 November, is from a Phase III trial involving 1296 patients with mild to moderate Covid-19. Junshi reports that BA.5.2.48 and BF.7.14 were the leading subvariants in the enrolled population.VV116 was approved for marketing in China for adult patients with mild to moderate Covid-19 in January 2023.

An interim analysis of the multicentre, double-blind, randomised trial (NCT05582629) found that VV 116 was superior to placebo in reducing the time to sustained clinical symptom resolution. A final analysis showed that VV 116 led to a median 10.9-day reduction in the time to sustained clinical symptom resolution compared to 12.9 days in the placebo cohort.

An active comparator-controlled Phase III study (NCT05341609), with results published in the New England Journal of Medicine in May 2023, showed that VV 116 was non-inferior to Pfizer’s Paxlovid (nirmatrelvir/ritonavir) in reducing the time to sustained clinical symptom resolution. The results also indicated fewer safety concerns for Junshi’s drug compared to Paxlovid. Paxlovid is the recommended antiviral pill by the US National Institutes of Health. In 2024, Paxlovid is forecast to see sales of $2 billion, according to GlobalData’s drugs database.

VV 116, an oral nucleoside analogue, has shown to be efficacious in patients despite the presence of high-risk factors for progression to severe Covid-19. The antiviral treatment works by inhibiting the replication of SARS-CoV-2.

See- "Oral VV 116 versus placebo in patients with mild-to-moderate COVID-19 in China: a multicentre, double-blind, phase 3, randomised controlled study".Xiaohong Fan, MD ,Xiahong Dai, MD , Yun Ling, MD , Lihua Wu, MD , Lingling Tang, MD ,et al. Published: November 22, 2023DOI:https://doi.org/10.1016/S1473-3099(23)00577-7.