Final Up to date on Could 25, 2022 by GlobeNewsWire
–the examine reached its main endpoint(VV116 was statistically superior) and secondary efficacy endpoint
–VV116 has a positive security profile and fewer opposed occasions than PAXLOVID
SHANGHAI, China, Could 25, 2022 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a number one innovation-driven biopharmaceutical firm devoted to the invention, growth, and commercialization of novel therapies, introduced at this time that the Part III scientific examine (NCT05341609) evaluating the efficacy and security of VV116 (JT001) and nirmatrelvir/ritonavir (“PAXLOVID”) within the remedy of sufferers with delicate to reasonable COVID-19 who’re at excessive threat for development to extreme COVID-19 together with dying, has reached its pre-specified main endpoint and secondary efficacy endpoint. The examine outcomes present that in comparison with PAXLOVID, VV116 (JT001) offered sufferers with a shorter median time to sustained scientific restoration, reaching statistical superiority.
VV116 (JT001) is a brand new oral nucleoside analog anti-SARS-CoV-2 investigational drug collectively developed by Junshi Biosciences and Vigonvita Life Sciences Co., Ltd (“Vigonvita”). In earlier Part I trials, VV116 (JT001) exhibited good security, tolerability, and pharmacokinetics in wholesome topics. At current, the double-blind, placebo-controlled, worldwide multiregional heart Part III trial evaluating VV116 for the remedy of delicate to reasonable COVID-19 who’re at excessive threat for development to extreme COVID-19 together with dying is underway, and numerous scientific research for delicate, reasonable and extreme COVID-19 are additionally in progress.
The NCT05341609 examine is a multicenter, single-blind, randomized, managed Part III examine evaluating the efficacy and security of VV116 (JT001) as compared with PAXLOVID within the early remedy of sufferers with delicate to reasonable COVID-19 who’re at excessive threat for development to extreme COVID-19 and dying. The trial was performed after communication with regulatory authorities. A complete of 822 sufferers have been enrolled and a single-blind design was adopted in order to hide the distribution of therapeutic medication to each the investigators (together with the endpoint evaluator) and the examine sponsor. The first endpoint was “time to sustained scientific restoration,” and the secondary endpoints included “share of contributors who had development of COVID-19 (outlined as development to extreme and/or vital COVID-19 and dying from any trigger) by Day 28,” “time to sustained disappearance of scientific signs,” “share of contributors who turned damaging for SARS-CoV-2,” and many others.
The outcomes of this Part III examine, evaluating VV116 (JT001) as a remedy for sufferers with delicate to reasonable COVID-19 who’re at excessive threat for development to extreme COVID-19 and dying, present that the predetermined main endpoint has been reached. As compared with sufferers within the PAXLOVID arm, these within the VV116 (JT001) arm exhibited a shorter time to sustained scientific restoration and achieved statistical superiority, a consequence that demonstrates VV116’s (JT001) capability to speed up the alleviation of COVID-19 signs.
By way of the secondary efficacy endpoints, there have been no COVID-19 illness development or dying within the VV116 (JT001) arm or PAXLOVID arm. The analysis workforce additionally noticed that VV116 (JT001) confirmed a pattern towards superiority to PAXLOVID within the time to sustained disappearance of scientific signs and the time to affected person testing damaging for SARS-CoV-2 for the primary time.
As for security, VV116 (JT001) has an excellent security profile and its total incidence of opposed occasions (“AE”) is decrease than that of PAXLOVID.
Detailed information will likely be printed by Junshi Biosciences in a medical journal at a later date.
About VV116 (JT001)
VV116 is an oral nucleoside analog drug that may inhibit the replication of SARS-CoV-2. Throughout preclinical pharmacodynamic research, VV116 exerted an antiviral impact on the unique pressure of the novel corinavirus and its recognized variants in vitro; within the mice mannequin, a low dose of VV116 lowered the virus titers beneath the detection restrict, considerably lowered the probabilities of lung harm and displayed a powerful antiviral impact. Preclinical pharmacokinetics and different analysis outcomes additionally present that VV116 has excessive oral bioavailability. Following oral administration and absorption, VV116 is quickly metabolized into father or mother nucleoside and broadly distributed all through the physique.
VV116 was collectively developed by the Shanghai Institute of Materia Medica, Chinese language Academy of Sciences; the Wuhan Institute of Virology, Chinese language Academy of Sciences; Xinjiang Technical Institute of Physics and Chemistry, Chinese language Academy of Sciences; Central Asian Heart of Drug Discovery and Improvement Chinese language Academy of Sciences / China-Uzbekistan Medication Technical Park (the Joint Laboratory of the Ministry of Science and Expertise underneath the “The Belt and Street Initiative”); Vigonvita Life Sciences Co., Ltd. (“Vigonvita”); and Junshi Biosciences. Junshi Biosciences and Vigonvita are liable for the scientific growth and industrialization of VV116 worldwide. The areas of cooperation is international except for 5 Central Asian international locations, Russia, North Africa and the Center East.
Junshi Biosciences and Vigonvita have accomplished three Part I research with wholesome Chinese language topics, and analysis outcomes have been printed in Acta Pharmacologica Sinica, a widely known journal within the pharmaceutical subject. VV116 is at present in a world, multicenter Part III trial, and numerous scientific research for delicate, reasonable and extreme COVID-19 are in progress.
In 2021, VV116 was permitted in Uzbekistan for the remedy of sufferers identified with reasonable to extreme COVID-19.
About Junshi Biosciences
Based in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical firm devoted to the invention, growth, and commercialization of revolutionary therapeutics. The corporate has established a diversified R & D pipeline comprising over 50 drug candidates, with 5 therapeutic focus areas overlaying most cancers, autoimmune, metabolic, neurological, and infectious ailments. Junshi Biosciences was the primary Chinese language pharmaceutical firm that obtained advertising and marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA monoclonal antibody for tumors was the primary on the earth to be permitted for scientific trials by the FDA and NMPA and has since entered Part Ib/II trials in each China and the US. Its anti-PCSK9 monoclonal antibody was the primary in China to be permitted for scientific trials by the NMPA.
Within the face of the pandemic, Junshi Biosciences’ response was robust and fast, becoming a member of forces with Chinese language and worldwide scientific analysis establishments and enterprises to develop an arsenal of drug candidates to fight COVID-19, taking the initiative to shoulder the social duty of Chinese language pharmaceutical firms by prioritizing and accelerating COVID-19 R&D. Among the many many drug candidates is JS016 (etesevimab), China’s first neutralizing absolutely human monoclonal antibody towards SARS-CoV-2 and the results of the mixed efforts of Junshi Biosciences, the Institute of Microbiology of the Chinese language Academy of Science and Lilly. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (“EUA”) in over 15 international locations and areas worldwide. In the meantime, VV116, a brand new oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, is in international Part III scientific trials. The JS016 and VV116 applications are part of the corporate’s steady innovation for illness management and prevention of the worldwide pandemic.
Junshi Biosciences has greater than 2,800 staff in the US (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For extra data, please go to: http://junshipharma.com.
Junshi Biosciences Contact Data
+ 86 021-2250 0300
+ 1 646-389-6658
+ 86 021-6105 8800