2024-12-25

On the 24th, SINEW PHARMA announced that its innovative pain relief drug, SNP-810, a high-liver-safety acetaminophen, has successfully completed toxicology testing on large animals (dogs) conducted by the globally renowned Charles River Laboratories. The results confirmed that the drug maintains excellent safety even at extremely high doses (equivalent to 38 tablets of 500 mg).

SINEW PHARMA stated that the scientific rigor and reliability of this trial comply with international Good Laboratory Practice (GLP) standards. These data provide a critical foundation for regulatory agencies such as the U.S. FDA and the European EMA to evaluate the safety and efficacy of the new drug for market approval.

Charles River Laboratories is one of the most prestigious Contract Research Organizations (CROs) globally, specializing in toxicology and safety studies. With over 17,000 employees and more than 6,000 biopharmaceutical clients, the company is a leader in its field. Previously, SINEW PHARMA commissioned Charles River to conduct toxicology tests on mice for SNP-810, which also demonstrated the drug’s safety at extremely high acetaminophen doses, showing no signs of liver toxicity.

In the dog study, doses of 200 and 500 mg/kg/day acetaminophen (equivalent to a 70 kg adult consuming 15 and 38 tablets of 500 mg acetaminophen daily) resulted in no toxic reactions. Throughout the trial, no abnormalities were observed in the animals’ weight, body temperature, or organ examinations, and no deaths occurred. Only at an intermediate dose of 360 mg/kg/day did two dogs show slightly elevated liver function markers and mild hepatocellular damage, which did not meet the criteria for liver toxicity and was likely due to individual differences.

SINEW PHARMA noted that these findings, combined with previous toxicology data from rat studies conducted by QPS Taiwan, a U.S.-based toxicology research organization, and the upcoming 4–12 g human trial results, will provide strong support for SNP-810’s FDA and EMA approval applications. The company is committed to advancing SNP-810 as a market leader in pain relief and antipyretic drugs with superior liver safety.

SOURCE