Sinew Pharma (6634) held an earnings call today (6th), where Chairman Kai-Min Chu stated that their new acetaminophen pain reliever, SNP-810 (SafeTynadol), has successfully completed clinical trials at three times the currently allowable dosage in humans. A total of 48 subjects participated in the trial, with daily dosages ranging from 4 to 12 grams. They obtained formal statistical results at the end of last month, and during the trial, no clinically significant liver toxicity, as defined by the American Association, or any other "serious adverse reactions" occurred. These results confirm that SNP-810, when used at a dosage three times the maximum allowable limit of existing acetaminophen products, is a acetaminophen pain reliever with high liver safety.
Kai-min Chu pointed out that this trial is one of the important verification and registration clinical trials for the company’s high liver safety acetaminophen pain reliever, SNP-810 (SafeTynadol). The purpose of this clinical trials conducting at three times the allowable dosage is not to change the current indication and therapeutic dosage of acetaminophen but to demonstrate, through rigorous human testing, that using Sinew’s acetaminophen SNP-810 (safeTynadol) will not cause significant liver damage even when the allowable dosage is tripled.
Acetaminophen is the most widely used pain reliever globally, with the global market valued at $9.44 billion in 2021, including an $8.64 billion over-the-counter (OTC) market. It is projected that by 2031, the market could reach $14.06 billion. North America is the leading market, accounting for 33%, followed by Europe (26.3%), East Asia (18.6%), and South Asia (13.1%).
There are hundreds of medications that contain acetaminophen, and overdose often occurs due to combination use, making it a primary cause of acute liver failure worldwide. There are over 276 acetaminophen-containing products in Taiwan and over 600 in the United States. Clinically, acetaminophen is commonly combined with medications for pain relief, fever, runny nose, and colds. Inadvertent combination use can lead to liver damage or even death. Additionally, individuals who frequently consume alcohol or have pre-existing liver issues are at a higher risk for liver damage from this ingredient. This liver damage problem has persisted for 40 years without resolution.
Sinew Pharma stated that compared to other acetaminophen pain relievers on the market, SNP-810 offers a wider safety margin, significantly reducing the likelihood of liver damage from acetaminophen. Currently, there are no competitors in the market, and the company’s goal is to "replace" existing acetaminophen products with their high liver safety alternative.
Kai-min Chu mentioned that the announcement of these clinical trial results marks an important milestone for the company. In addition to obtaining the formal test report from Charles River Laboratories, a well-known third-party toxicology testing company, confirming SNP-810’s safety at extremely high dosages in animals, there is also direct evidence of liver safety in humans.
Furthermore, SNP-810 was tested in combination with a previously marketed non-addictive pain relief medication for postoperative pain control in patients undergoing unilateral or bilateral knee replacements. This clinical trial was completed in November last year, involving 36 subjects, and no liver toxicity or serious adverse reactions related to the trial drug were observed during the process. This study provides clinical data regarding the liver safety of the medication in pain relief. Kai-min Chu expects to fully disclose the trial results in August this year, and this product is expected to help alleviate the serious problem of deaths caused by opioid overdoses. It offers a safe alternative to prevent opioid addiction, respiratory depression, and death, with the market for such alternatives estimated to reach $53.6 billion by 2033.
Regarding Sinew Pharma’s SNP-6 series aimed at treating "Metabolic Dysfunction-Associated Steatohepatitis (MASH)" (formerly known as non-alcoholic steatohepatitis, NASH), the company successfully completed the Phase I clinical trial of SNP-630 last year, confirming no safety issues. The company is actively preparing to apply for Phase II clinical trials with the TFDA and US FDA. Currently, the ongoing toxicology studies have received partial exemptions from the Center for Drug Evaluation (CDE). The active metabolites have also provided safe and effective clinical data through Phase II clinical trials, and preparations are underway to initiate the randomized, double-blind, placebo-controlled Phase II clinical trials for SNP-610 that meet US FDA and TFDA approval.
Additionally, Sinew Pharma has been invited to participate in the 8th MASH Drug Development Summit held in Boston, USA, from September 24 to 26, where they will present two themed reports. Participants include senior executives and R&D directors from major global companies developing MASH drugs, such as Pfizer, Gilead, AstraZeneca, and Merck, which is expected to significantly enhance Sinew Pharma’s international visibility and business development opportunities for the SNP-6 series.
