On November 2, 2023, an expert discussion meeting on the Phase II/III clinical trial protocol for the treatment of respiratory syncytial virus (RSV) infection in infants and young children with deuremidevir hydrobromide (VV116) was successfully held at Shulan (Hangzhou) Hospital, adopting a combination of online and offline. Li Lanjuan, an academician of the CAE, a famous infectious disease scientist in China and the leading PI of this research, attended and presided over the meeting. Experts from 10 clinical research institutions and research institutions across the country, as well as project teams from the sponsor, Vigonvita Life Sciences Co., Ltd., jointly participated in this conference.
The attending experts fully discussed the key design of clinical trials for the treatment of respiratory syncytial virus infection in infants and young children, as well as the specific problems that may be encountered in the actual execution of clinical trials, including endpoint indicators, blood collection point design, combination therapy, and sample collection. At this meeting, experts provided valuable professional suggestions through thorough discussions, laying a solid foundation for the smooth implementation of subsequent clinical trials.
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On January 28, 2023, VV116 tablets passed the special approval process of the NMPA and were conditionally approved for sale, with trade name Mindvy?，?used to treat adult patients with mild to moderate COVID-19.
VV116 dry suspension and tablets share the same active ingredients. Compared to tablets, dry suspension is more convenient to administer and is more suitable for pediatric use. VV116 has excellent antiviral effects on multiple sensitive cell lines of respiratory syncytial virus (RSV), and has shown good antiviral effects in mice and cotton mice. The clinical study of VV116 dry suspension for the treatment of RSV infection indications was approved by the NMPA on May 4, 2023.
At present, the Phase I clinical study of VV116 dry suspension in healthy adult subjects has been successfully completed at Huashan Hospital affiliated to Fudan University. The experimental results showed that a single oral administration of 25, 100, and 300 mg of VV116 dry suspension resulted in a proportional increase in the main pharmacokinetic parameters of the main metabolite 116-N1, which conforms to linear pharmacokinetic characteristics; the simultaneous use of infant formula has no significant effect on the bioavailability of 116-N1; and the safety is good.