Taiwan-based emerging biotech company SINEW PHARMA recently issued a major announcement, stating that it has obtained the final clinical report for SNP-810 (Anteinatone), a novel pain relief drug with high hepatic safety. The report confirms that SNP-810 showed no liver toxicity even at a dosage three times the recommended limit for acetaminophen (12 grams per day). SINEW PHARMA emphasized that healthy individuals taking up to 12 grams per day did not experience liver failure or liver damage, indicating a higher safety profile compared to existing acetaminophen formulations.
According to the company, the clinical trial was a multi-dose, single-blind, single-center, oral administration safety study, comparing SNP-810 (Anteinatone) and Panadol (acetaminophen). A total of 48 participants received doses ranging from 4 to 12 grams per day.
SINEW PHARMA stated that the clinical study was conducted by an international third-party clinical trial consulting firm, and the final report is a key component of the regulatory submission for SNP-810’s high hepatic safety validation. The company plans to submit the report to Taiwan’s Ministry of Health and Welfare (MOHW) for review. It also clarified that the study’s purpose was to demonstrate that SNP-810 does not cause liver failure or hepatotoxicity even at high doses, rather than to alter the indications or recommended dosage of acetaminophen.
The final report was completed on February 11 by the third-party consultant. SINEW PHARMA intends to proceed with regulatory filings based on the final data and will issue an official announcement upon regulatory approval. In addition, the company plans to use the findings to apply for high-dose acetaminophen hepatic safety validation trialswith domestic and international health authorities.
SINEW PHARMA also released clinical data analysis results, showing that none of the participants in the 4 to 12 gram daily dose groups exhibited liver toxicity. Secondary outcome measures confirmed no cases of liver injury or liver failure, and all dosage groups remained below the hepatotoxicity threshold.
In its key conclusions, SINEW PHARMA stated that an evaluation of adverse events and all other safety parametersindicated that SNP-810 (Anteinatone) was well-tolerated and safe across all dosage levels in healthy participants. The data further confirmed that SNP-810 has a higher safety profile, as healthy individuals taking up to 12 grams per day did not develop liver failure or liver damage.
Looking ahead, SINEW PHARMA plans to submit the pivotal clinical validation report to the MOHW for reviewand proceed with regulatory registration based on the final report findings. Once approved, the company will issue a formal announcement. Additionally, based on the clinical findings, SINEW PHARMA will apply for high-dose acetaminophen hepatic safety validation trials with global regulatory agencies and discuss whether further studies are required before market approval.
Resource: 欣耀公告取得止痛新藥SNP-810臨床最終報告 指出其擁有「更高安全性」
