Clinical Trial for Azvudine for Post-Exposure Prophylaxis of COVID-19 Infection Approved in the Philippines

Recently, a clinical trial for the oral small-molecule antiviral drug Azvudine tablets for post-exposure prophylaxis of COVID-19 infection was approved in the Philippines under a strategic collaboration between Genuine Biotech and Fosun Pharma.

The approved clinical trial is a randomized, double-blind, placebo-controlled phase II/III clinical trial to evaluate the efficacy and safety of Azvudine versus placebo in preventing SARS-CoV-2 infection in household contacts of individuals infected with SARS-CoV-2.

The clinical trial will consist of two stages. Stage one is a multicenter, randomized, double-blind, three-arm phase II clinical study in which eligible subjects will be randomly assigned to one of 3 treatment groups with a 1:1:1 ratio (group A: Azvudine tablets 5 mg orally administered once daily; group B: Azvudine tablets 3 mg + placebo 2 mg orally administered once daily; group C: placebo 5 mg orally administered once daily), and treatment with the study drug or placebo will last for 7 days. Stage two is a multicenter, randomized, double-blind, parallel-controlled phase III clinical study in which eligible subjects will be randomly assigned to one of 2 treatment groups with a 1:1 ratio (Arm 1 [trial group]:Azvudine tablets orally administered once daily at a dose determined based on the results of the Phase II trial; Arm 2 [control group]: placebo orally administered once daily at the same dose as Arm 1), and treatment with the study drug or placebo will last for 7 days. The primary endpoint of the clinical trial is the proportion of subjects tested positive for SARS-CoV-2 by RT-PCR within 7 days, and secondary endpoints include safety, pharmacokinetic parameters, and efficacy.

Azvudine tablets is the first oral small-molecule drug independently developed in China for the treatment of COVID-19 and was conditionally approved by the NMPA on Jul. 25, 2022. On Aug. 9, 2022, the General Office of the National Health Commission and the Office of National Administration of Traditional Chinese Medicine included Azvudine tablets in the Diagnosis and Treatment Guideline for COVID-19 (9th Edition).On Dec. 7, 2022, Azvudine was included in the latest version of Clinical Pharmacy Guideline for Antiviral Treatment of COVID-19 published by Guangdong Pharmaceutical Association. On Dec. 17, Henan Pharmaceutical Association published the Expert Consensus on the Use of Azvudine for the Treatment of COVID-19. The results of phase III clinical trial for Azvudine in the treatment of COVID-19 infection show that, Azvudine has significant efficacy of inhibiting the replication of SARS-CoV-2 virus, accelerating clearance of SARS-CoV-2 virus, alleviating symptoms, and shortening disease course, at a low dosage level that makes it safer. Furthermore, as the target SARS-CoV-2 RdRp is relatively conservative with a low mutation rate, Azvudine has the potential of fighting multiple variants efficiently.

On Jul. 25, 2022, Genuine Biotech announced a strategic collaboration with Fosun Pharma, under which the two companies will jointly develop Azvudine which will be exclusively commercialized by their subsidiary Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. Both parties will leverage their respective strengths for cooperation in China (excluding the regions of Hong Kong, Macau, and Taiwan) and potentially globally beyond China's interests (excluding Russia, Ukraine, Brazil, and other South American countries and regions) in the future.