Chairman of Sinew Pharma (6634), Kai-min Chu, stated during an earnings call on the 6th that their new acetaminophen pain reliever SNP-810 (SafeTynadol) has successfully completed clinical trials where it was administered at three times the currently allowed dosage in humans. A total of 48 subjects were included in the trial, with daily dosages ranging from 4 to 12 grams. During the trial, no significant liver toxicity, as defined by the American Association, or any other "serious adverse reactions" were observed, confirming that SNP-810 is a new acetaminophen pain reliever with high liver safety.
Kai-min Chu noted that the issue of acetaminophen causing liver damage has persisted for 40 years without resolution. Compared to other acetaminophen pain relievers on the market, SNP-810 offers a wider safety margin, significantly reducing the risk of liver damage. Currently, there are no competitors in the market, and Sinew's goal is to "replace" existing acetaminophen products with their high liver-safety alternative.
Acetaminophen is the most widely used pain reliever globally, with the global market valued at $9.44 billion in 2021, including $8.64 billion from the over-the-counter (OTC) market. It is projected that by 2031, the market could reach $14.06 billion. North America leads the market, accounting for 33%, followed by Europe (26.3%), East Asia (18.6%), and South Asia (13.1%).
Due to the presence of acetaminophen in over hundreds of drugs, it is often used in combination, leading to overdose, which is the primary cause of acute liver failure worldwide. There are more than 276 acetaminophen-containing drugs in Taiwan and over 600 in the United States.
In addition, SNP-810 was tested in combination with a previously invented non-addictive pain relief drug for postoperative pain control in patients undergoing unilateral or bilateral knee replacements. This clinical trial, which included 36 participants, was completed in November last year, and no liver toxicity or serious adverse reactions related to the study drug were observed.
Kai-min Chu mentioned that the full trial results are expected to be released in August this year. This product could potentially provide relief from the serious issue of deaths caused by opioid overdoses. It offers a safer alternative to prevent opioid addiction, respiratory depression, and death. The market for such alternatives is expected to reach $53.6 billion by 2033.
As for the SNP-6 series of drugs aimed at treating "Metabolic Dysfunction-Associated Steatohepatitis (MASH)" (formerly known as non-alcoholic steatohepatitis, NASH), the Phase I clinical trial of SNP-630 was successfully completed last year, and preparations are underway to apply for Phase II clinical trials with the Taiwan TFDA and the U.S. FDA.
