Registration Phase III VV116 Trial Versus PAXLOVID for Early Treatment of Mild to Moderate COVID-19 in High-Risk Patients Reaches Primary Endpoint


Junshi Biosciences

–the study met its primary endpoint (VV116 was statistically superior) and its secondary endpoint

–VV116 has a favorable safety profile and fewer adverse events than PAXLOVID

SHANGHAI, China, May 25, 2022 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery , the development, and commercialization of new therapies, today announced that the Phase III clinical study (NCT05341609) comparing the efficacy and safety of VV116 (JT001) and nirmatrelvir/ritonavir (“PAXLOVID”) in the treatment of patients with mild to moderate COVID-19 who are at high risk of progression to severe COVID-19, including death, met its primary endpoint and its secondary endpoint of preset efficiency. Study results show that, compared to PAXLOVID, VV116 (JT001) provided patients with a shorter median time to sustained clinical recovery, achieving statistical superiority.

VV116 (JT001) is an investigational novel anti-SARS-CoV-2 oral nucleoside analogue drug jointly developed by Junshi Biosciences and Vigonvita Life Sciences Co., Ltd (“Vigonvita”). In previous phase I trials, VV116 (JT001) showed good safety, tolerability and good pharmacokinetics in healthy subjects. Currently, the international, multi-regional, double-blind, placebo-controlled Phase III trial evaluating VV116 for the treatment of mild to moderate COVID-19 that is at high risk of progression to severe COVID-19, including death, is ongoing, and a number of clinical studies for mild, moderate, and severe COVID-19 are also ongoing.

The NCT05341609 study is a multicenter, single-blind, randomized, controlled phase III study evaluating the efficacy and safety of VV116 (JT001) versus PAXLOVID in the early treatment of patients with mild to moderate COVID-19 who are at high risk of progression to severe COVID-19 and death. The trial was conducted after communication with regulatory authorities. A total of 822 patients were recruited and a single-blind design was adopted in order to conceal the distribution of therapeutic drugs from the investigators (including the endpoint evaluator) and the study sponsor. The primary endpoint was “time to sustained clinical recovery” and secondary endpoints included “percentage of participants who had progression of COVID-19 (defined as progression to severe COVID-19 and /or critical and one death from any cause) on day 28”, “time until lasting resolution of clinical symptoms”, “percentage of participants who became negative for SARS-CoV-2”, etc.

The results of this phase III study, evaluating VV116 (JT001) as a treatment for patients with mild to moderate COVID-19 who are at high risk of progression to severe COVID-19 and death, show that the endpoint pre-determined principal valuation has been reached. Compared to patients in the PAXLOVID arm, those in the VV116 (JT001) arm had a shorter time to sustained clinical recovery and achieved statistical superiority, a result that demonstrates the ability of VV116 (JT001) to accelerate symptom relief. of COVID-19.

In terms of secondary efficacy endpoints, there was no COVID-19 disease progression or death in the VV116 (JT001) arm or the PAXLOVID arm. The research team also observed that VV116 (JT001) showed a trend of superiority over PAXLOVID in time to sustained resolution of clinical symptoms and time to patient testing negative for SARS-CoV-2 for the first time.

Regarding safety, VV116 (JT001) has a good safety profile and its overall incidence of adverse events (“AE”) is lower than that of PAXLOVID.

Detailed data will be published by Junshi Biosciences in a medical journal at a later date.

About VV116 (JT001)
VV116 is an oral nuke that can inhibit SARS-CoV-2 replication. During preclinical pharmacodynamic studies, VV116 exerted an antiviral effect on the original strain of the new corinavirus and its known variants in vitro; in the mouse model, a low dose of VV116 reduced virus titers below the detection limit, significantly reduced the risk of lung damage, and displayed a strong antiviral effect. Preclinical pharmacokinetics and other research results also show that VV116 has high oral bioavailability. After oral administration and absorption, VV116 is rapidly metabolized to the parent nucleoside and widely distributed throughout the body.

VV116 was jointly developed by Shanghai Institute of Materia Medica, Chinese Academy of Sciences; Wuhan Institute of Virology, Chinese Academy of Sciences; Xinjiang Technical Institute of Physics and Chemistry, Chinese Academy of Sciences; Central Asian Center for Drug Discovery and Development Chinese Academy of Sciences/China-Uzbekistan Medical Technical Park (joint laboratory of the Ministry of Science and Technology under the Belt and Road Initiative) ; Vigonvita Life Sciences Co., Ltd. (“Vigonvita”); and Junshi Biosciences. Junshi Biosciences and Vigonvita are responsible for the clinical development and industrialization of VV116 worldwide. The areas of cooperation are global with the exception of five countries in Central Asia, Russia, North Africa and the Middle East.

Junshi Biosciences and Vigonvita have completed three Phase I studies with healthy Chinese subjects, and the research results have been published in Acta Pharmacologica Sinica, a well-known journal in the pharmaceutical field. VV116 is currently undergoing an international multicenter phase III trial and a number of clinical studies in mild, moderate and severe COVID-19 are ongoing.

In 2021, VV116 was approved in Uzbekistan for the treatment of patients diagnosed with moderate to severe COVID-19.

About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies. The company has established a diverse R&D pipeline comprising more than 50 drug candidates, with five therapeutic areas covering cancer, autoimmune, metabolic, neurological and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company to obtain marketing authorization for an anti-PD-1 monoclonal antibody in China. Its first-in-man anti-BTLA monoclonal antibody for tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and has since entered Phase Ib/II trials in China and the United States. -United. Its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA.

In the face of the pandemic, Junshi Biosciences’ response has been strong and immediate, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to fight COVID-19, taking the lead in assume the social responsibility of Chinese pharmaceutical by prioritizing and accelerating COVID-19 R&D. Among the many drug candidates is JS016 (etesevimab), China’s first fully human neutralizing monoclonal antibody against SARS-CoV-2 and the result of the combined efforts of Junshi Biosciences, Institute of Microbiology, Chinese Academy of science and Lilly. JS016 administered with bamlanivimab has obtained Emergency Use Authorizations (“EUAs”) in more than 15 countries and regions worldwide. Meanwhile, VV116, a new anti-SARS-CoV-2 oral nucleoside analogue drug designed to hamper virus replication, is in global Phase III clinical trials. The JS016 and VV116 programs are part of the company’s continued innovation for disease control and global pandemic prevention.

Junshi Biosciences has more than 2,800 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

Contact details of Junshi Biosciences
IR Team:
Junshi Biosciences
[email protected]
+ 86 021-2250 0300

World Goby
Bob Ai
[email protected]
+1 646-389-6658

PR team:
Junshi Biosciences
Zhi Li
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+ 86 021-6105 8800