On August 8, Microbio and Oneness Biotech jointly announced that SNS812, an antiviral nucleic acid drug developed by Oneness Biotech and Microbio’s subsidiary Microbio Shanghai to treat COVID-19 infections, has successfully met the primary and key secondary endpoints in its Phase II clinical trial. The results indicate that SNS812 is safe and demonstrates significant clinical efficacy against various high immune escape variants, including the globally prevalent JN.1 strain.
Microbio Group emphasized that SNS812 is currently the only broad-spectrum clinical drug globally effective against multiple COVID-19 variants. It shows superior efficacy in symptom improvement compared to Paxlovid, which holds a 70% market share globally.
Shuling Cheng, General Manager of Oneness Biotech, stated that the trial was conducted at National Taiwan University Hospital and the three hospitals of Taipei Medical University Hospital (TMUH, Shuang Ho Hospital, and Wanfang Hospital). It followed a rigorous international standard design mandated by the U.S. FDA, involving a randomized, double-blind, placebo-controlled format. The trial included three groups—high dose (200 mg), low dose (100 mg), and placebo—with 45 participants per group, totaling 135 participants. Results showed that SNS812, administered via inhalation, had an excellent safety profile with no drug-related adverse reactions. The time to complete resolution of target symptoms caused by the infection (including fever, sore throat, chills, headache, shortness of breath, nausea, vomiting, loss of smell, and loss of taste) was significantly shorter in the SNS812 groups compared to the placebo group (P=0.007), proving its superiority over other internationally available drugs.
Cheng further explained that genetic sequencing of the viral strains in all trial participants covered several of the latest globally circulating viral lineages, including JN.1, KP1-4, LB.1, BA.2, and XBB. High immune escape variants (such as JN.1, KP1-4, and LB.1) accounted for 90% of cases, demonstrating that SNS812 has broad efficacy and is currently unmatched worldwide.
Owen Chang, General Manager of Microbio Shanghai, added that the SNS812 group reached virus clearance (transition from positive to negative) significantly earlier than the placebo group (P=0.018). In the high-dose SNS812 group (200 mg), the median time to virus clearance was just 2.9 days. Furthermore, SNS812 showed significant clinical efficacy in improving central nervous system-related symptoms, such as loss of taste and smell, as well as reducing symptoms like shortness of breath, fever, and chills, which are commonly associated with severe cases of COVID-19.
Chang emphasized that many existing COVID-19 drugs have significant side effects, and vaccines currently in development cannot keep pace with the rapid mutation of viral strains, rendering them ineffective. The success of SNS812 in this trial represents not only a significant achievement for Oneness Biotech and Microbio Shanghai but also a major breakthrough for the global medical community. Moving forward, Oneness Biotech and Microbio Shanghai will jointly promote international collaborations for SNS812, aiming to secure Emergency Use Authorization (EUA) and market approval in major countries or regions as soon as possible.
According to data released by the U.S. Centers for Disease Control and Prevention (CDC), new COVID-19 variants emerge approximately every three months, and vaccine development cannot keep up with the rate of viral mutation. The U.S. government has initiated special programs to encourage the development of new therapies that can overcome these variants. Globally, there is an urgent need for a breakthrough solution to effectively treat or prevent the ongoing threat posed by COVID-19 to humanity.
Resource (mandarin): 合一治療新冠病毒感染新藥SNS 812二期試驗 成功解盲
