Clinical Trials Arena

Junshi publishes positive Phase III results for Covid-19 pill VV116

The antiviral tablet, already approved in China in January 2023, significantly reduced the time to sustained clinical symptom resolution.

Junshi Biosciences has revealed the final results for its Covid-19 pill VV116 (mindeudesivir hydrobromide), indicating its efficacy.

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 Junshi’s drug was superior to placebo in reducing the time to sustained clinical symptom resolution. A final analysis showed that VV116 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 VV116 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, The pill is forecast to see sales of $2bn, according to GlobalData’s drugs database.

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The drug, 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.

Junshi’s global research and development president Dr Jianjun Zou said: “As of today, more than 3,000 patients worldwide are actively participating in our clinical trials for VV116, including several domestic and international Phase III trials.”

Last month, Junshi announced its nasopharyngeal cancer drug, which is co-developed with Coherus BioSciences, received US Food and Drug Administration approval. Toripalimab, which will be sold under the brand name Loqtorzi, is expected to go on the US market in Q1 2024, according to Coherus’ press release on 27 October.

The drug was first approved in 2018 for multiple types of cancer and marketed as Tuoyi in China, according to GlobalData’s drugs database.