Oneness Biotech and Microbio (Shanghai) announced that the pan-COVID New Drug, SNS812, co-developed by both companies achieves statistical significance with clinically meaningful endpoints in the Phase 2 trial. SNS812 has demonstrated good safety and efficacy in treating various virus strains including the currently prevalent strain JN.1 and many high immune-escape variants.

SNS812 is the only therapeutic with a broad-spectrum efficacy in multiple coronavirus variants. It has much more clinical advantages compared with Paxlovid, a Pfizer's drug with 70% market share.

Dr. Shuling Cheng, the President of Oneness Biotech commented that this randomized, double-blind, placebo-controlled study was conducted at the National Taiwan University Hospital and 3 hospitals affiliated with Taipei Medical University (TMUH, Shuangho Hospital, and Wangfang Hospital) in compliance with the FDA's requirements. There were 3 cohorts with SNS812 200mg, SNS812 100mg and placebo respectively with a total of 135 subjects; 45 subjects in each group. The study results demonstrate that SNS812 inhalation was well supported by clean safety profile without any drug-related adverse events. Compared with the placebo group, SNS812 group achieves statistical significance in all target symptoms related to COVID-19 infection, including the time to sustained alleviation and resolution of fever, sore throat, shivers, headache, shortness of breath, nausea, vomiting, loss of smell and taste (P=0.007). The study results suggest a better outcome than other therapeutics in the global market.

Dr. Shuling Cheng also points out that the genomic sequencing of the virus strains from all subjects demonstrates coverage of the latest prevalent genotypes, including JN.1, KP1-4, LB.1, BA.2, and XBB variants with 90% high immune-escape variants (JN.1、KP1-4 & LB.1). This also demonstrates that SNS812 is the only up-to-date COVID-19 new drug with broad-spectrum efficacy in the world.

Dr. Yi-Chung Chang, the President of Microbio (Shanghai) commented that SNS812 treatment group achieves viral-negative earlier than the placebo group (P=0.018). The median time to achieve viral-negative in SNS812 200mg group was 2.9 days. SNS812 also significantly improved the loss of smell and taste related to the CNS system. Compared with the placebo group, SNS812 shows superior efficacy in alleviating or resolving the symptoms, including shortness of breath, fever, shivers, etc., which usually lead to severe COVID-19.

Dr. Chang further explained that the current marketed COVID-19 therapeutics have side effects and the vaccines under development are lagged behind the evolution of the variants, which will not be effective. The SNS812 study readout is not only a great success for Oneness Biotech and Microbio (Shanghai), but also a worldwide medical breakthrough.

According to the COVID-19 variants data published by the Centers for Disease Control and Prevention (CDC), new variants almost emerge every three months. Vaccine development falls behind the viral mutation. The U.S. government has initiated a project to incentivize the development of new therapies to address the issue of COVID-19 mutation variants. Globally, there is an urgent need for breakthrough solution to effectively treat or prevent the COVID-19 outbreak to the humanity.