Oneness Biotech's SNS812 Demonstrates Superior Efficacy Against COVID-19 Variants in Phase 2 Trial
Key Insights
Oneness Biotech (search) and Microbio (Shanghai) (search)'s SNS812 achieved statistically significant and clinically meaningful endpoints in a Phase 2 trial for COVID-19 (search) treatment.
SNS812 demonstrated efficacy against prevalent COVID-19 (search) variants, including JN.1, KP1-4, LB.1, BA.2, and XBB, with a good safety profile and no drug-related adverse events.
The trial showed SNS812 significantly reduced the time to viral negativity (median 2.9 days in the 200mg group) and improved symptoms like loss of smell and taste compared to placebo.
Oneness Biotech (search) and Microbio (Shanghai) (search) have announced positive results from their Phase 2 clinical trial of SNS812, a pan-COVID-19 (search) drug. The study demonstrated that SNS812 achieved statistical significance across clinically meaningful endpoints, showcasing its potential as a broad-spectrum therapeutic for various coronavirus strains, including the currently dominant JN.1 variant and other high immune-escape variants.
The randomized, double-blind, placebo-controlled trial was conducted in compliance with FDA requirements at the National Taiwan University Hospital and three hospitals affiliated with Taipei Medical University. A total of 135 subjects were enrolled and divided into three cohorts receiving SNS812 200mg, SNS812 100mg, and placebo, respectively (45 subjects per group).
Efficacy and Safety Profile
The study results indicated that inhaled SNS812 was well-tolerated, with a clean safety profile and no drug-related adverse events reported. Compared to the placebo group, the SNS812 groups achieved statistical significance in alleviating COVID-19 (search)-related symptoms, including fever, sore throat, shivers, headache, shortness of breath, nausea, vomiting, and loss of smell and taste (P=0.007).
According to Dr. Yi-Chung Chang, President of Microbio (Shanghai) (search), the SNS812 treatment group achieved viral negativity earlier than the placebo group (P=0.018), with a median time to viral negativity of 2.9 days in the SNS812 200mg group. SNS812 also significantly improved the loss of smell and taste, symptoms related to the central nervous system.
Addressing Variant Evolution
Genomic sequencing of virus strains from all subjects demonstrated coverage of the latest prevalent genotypes, including JN.1, KP1-4, LB.1, BA.2, and XBB variants, with 90% being high immune-escape variants (JN.1, KP1-4 & LB.1). This suggests that SNS812 is a current COVID-19 (search) drug with broad-spectrum efficacy.
Dr. Shuling Cheng, President of Oneness Biotech (search), emphasized that the emergence of new COVID-19 (search) variants every three months, as reported by the CDC, necessitates the development of new therapies. The SNS812 study results suggest a better outcome than other therapeutics currently available.
The Need for Novel COVID-19 Therapies
Existing COVID-19 (search) therapeutics have side effects, and vaccine development lags behind viral mutation. The U.S. government has initiated projects to incentivize the development of new therapies to address the issue of COVID-19 mutation variants. The success of the SNS812 clinical trial represents a significant advancement in addressing the global need for effective COVID-19 treatments.