New COVID Drug SNS812 Superior in Phase 2 Trial

Oneness Biotech and Microbio (Shanghai) have announced impressive Phase 2 trial results for their jointly developed pan-COVID drug, SNS812. This new therapeutic has shown significant efficacy and safety across multiple coronavirus variants, including those with high immune escape.

The randomized, double-blind, placebo-controlled study was conducted at the National Taiwan University Hospital and three hospitals affiliated with Taipei Medical University. The trial included 135 subjects divided into three cohorts: SNS812 200mg, SNS812 100mg, and a placebo group, with 45 subjects in each cohort. The study revealed that SNS812 was well-tolerated with no drug-related adverse events. It achieved statistical significance in alleviating symptoms such as fever, sore throat, shivers, headache, shortness of breath, nausea, vomiting, and loss of smell and taste (P=0.007).

Dr. Shuling Cheng, President of Oneness Biotech, highlighted that SNS812 demonstrated broad-spectrum efficacy against the latest prevalent coronavirus genotypes, including JN.1, KP1-4, LB.1, BA.2, and XBB variants. The drug also showed effectiveness against 90% of high immune-escape variants, signifying it as the only up-to-date COVID-19 therapeutic with such a wide range of efficacy.

Dr. Yi-Chung Chang, President of Microbio (Shanghai), noted that the SNS812 treatment group showed earlier viral-negative results compared to the placebo group (P=0.018), with a median time of 2.9 days to achieve viral-negative status in the 200mg group. The drug also significantly improved symptoms related to the central nervous system, such as loss of smell and taste, and demonstrated superior efficacy in alleviating severe COVID-19 symptoms like shortness of breath, fever, and shivers.

Dr. Chang further explained that existing COVID-19 therapeutics often have side effects and that current vaccines are lagging behind viral evolution, making them less effective. The success of the SNS812 study is not only a milestone for Oneness Biotech and Microbio (Shanghai) but also represents a significant breakthrough in global medical science.

According to data from the Centers for Disease Control and Prevention (CDC), new COVID-19 variants are emerging approximately every three months, outpacing vaccine development. The U.S. government has initiated a project to incentivize the development of new therapies to address these rapidly mutating variants. There is a global urgent need for innovative solutions to effectively manage or prevent COVID-19 outbreaks.

Oneness Biotech, established in 2008 and public since 2011, has been a pioneering force in developing groundbreaking treatments. Its portfolio includes Fespixon® for chronic wounds, Bonvadis® medical device, FB825 (an Anti-IgE B cells mAb licensed globally for $530 million), and the newly successful SNS812. Oneness Biotech is also noted for its commitment to Environmental, Social, and Governance (ESG) standards, earning recognition in the Dow Jones Sustainability Emerging Markets Index and the S&P Sustainability Yearbook in both 2023 and 2024.

Microbio (Shanghai), a subsidiary of Taiwan's Microbio Co., Ltd., has been focusing on nucleic acid-based new drugs targeting viruses and bacteria. The success of SNS812 in clinical trials positions it as a key player in the global partnership strategy for subsequent development stages.

SNS812's promising Phase 2 results mark a significant advancement in the fight against COVID-19, offering hope for more effective treatments against a backdrop of continuously evolving viral threats.

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