On the 11th of this month, Sinew Pharma Inc. (6634.TWO), a company specializing in liver medicine, announced the clinical trial results for its high liver safety pain relief drug, SNP-810 (SafeTynadol). The results confirm that SNP-810 does not cause liver toxicity even when administered at three times the recommended dosage of acetaminophen (12 grams), a well-known pain relief ingredient in Panadol. The company plans to apply for high-dose acetaminophen clinical trials with domestic and international health authorities to further test the liver safety.
SNP-810 is an acetaminophen product with high liver safety that inhibits liver enzymes, preventing the formation of toxic metabolites that can harm the liver.
This clinical trial was a multi-dose, single-blind, single-center study evaluating the safety of oral administration of either Panadol (the control group) or the high liver safety pain relief drug SNP-810. A total of 48 participants were enrolled, receiving SNP-810 doses ranging from 4 to 12 grams. The highest dose tested (12 grams) exceeded the currently approved maximum daily dose of acetaminophen (4 grams) by three times.
The trial results showed no statistically significant differences in ALT peak levels between different SNP-810 dosage groups and the control drug group (P=0.1099), indicating that SNP-810 did not cause liver toxicity at daily doses ranging from 4 to 12 grams.
Furthermore, no cases of liver injury or liver failure occurred during the clinical trial. None of the participants had ALT levels exceeding three times the upper limit of normal (ULN), confirming no dosage group met the criteria for liver toxicity.
Among participants with ALT peak elevations above the ULN, three (6.25%) had ALT levels exceeding the ULN by one-fold, and two (4.17%) had ALT levels exceeding the ULN by two-fold.
The concentrations of AAP-Cys adducts and AAP-Cys, the primary metabolites indicating acetaminophen liver toxicity, were significantly below the liver toxicity threshold in all dosage groups, confirming the absence of liver toxicity as expected.
Sinew Pharma noted that after taking SNP-810 (SafeTynadol), the drug's half-life remained consistent across different dosage groups, with systemic exposure generally proportional to dosage and comparable across different groups. The metabolite AAP-Cys adducts, reflecting acetaminophen liver toxicity, showed no significant changes and remained far below the concentration associated with acetaminophen-induced liver injury.
Sinew Pharma emphasized the trial purpose was to demonstrate that SNP-810 does not cause liver failure nor liver toxicity even at excessive dosages in humans, rather than to change the current treatment indications or the recommended dosage for acetaminophen.
The company stated that SNP-810 was tested at doses exceeding the currently approved maximum daily acetaminophen dose of 4 grams, and the clinical results showed it has a higher liver safety profile. Healthy participants were able to take up to 12 grams per day without experiencing liver failure or liver injury. Moving forward, Sinew Pharma plans to use these findings to apply for high-dose acetaminophen liver safety clinical trials with regulatory authorities worldwide.
