Pain relief and fever reduction (New acetaminophen with high liver safety)

Inhibiting liver enzyme activity to prevent the generation of toxic metabolites of acetaminophen known to cause liver damage.

1. Single-dose, low- and high-dose as well as multiple-dose seven-day clinical trials have been completed.
2. SNP-810 clinical study in combination with a non-addictive k-opioid for management of moderate-to-severe pain has completed enrollment of patients undergoing knee replacement.
3. SNP-810 clinical study in combination with a non-addictive k-opioid for management of moderate-to-severe pain has completed enrollment of patients undergoing knee replacement.

1. SNP-810 is formulated with high liver safety to reduce hepatotoxicity and avoid death due to liver failure.
2. Currently there is no competitor on the market in terms of liver safety.
3. It has patents from various countries, has a wider safety margin in which US FDA label of hepatotoxicity warning can be modified or deleted, and is very competitive in the OTC (over-the-counter drug) market.
4. Able to seize a significant share of the expansive analgesic market, including NSAIDs, COX-2 inhibitors, and opioid combos.

According to the Future Market Insights report, the global acetaminophen analgesic market size was approximately US$9.44 billion in 2021, and with CAGR of 4.1%, the global analgesic market in 2031 is expected to reach US$14.07 billion.

Clinical trials

1. Clinical trial of single-dose, low- and high-dose have been completed. The function of SNP-810 effectively reducing the formation of the toxic metabolites of acetaminophen has been verified.
2. Multi-dose seven-day clinical trial: Total 12 subjects were enrolled with 6 subjects in each group. The results are in line with the expectations: The high dose can be used continuously for 7 days without any signs of hepatotoxicity.
3. SNP-810 besides high liver safety data, human bioequivalence study to commercially available Panadol has been performed and validated, proving that clinical efficacy of SNP-810 is equivalent to that of Panadol.
4. The clinical study testing the dosages reaching the triple of the recommended label dosage of acetaminophen has completed patient enrollment. This study aims to assess the safety of SNP-810 with oral dosages ranging from 4 to 12 grams per day. Enrollment of 48 people is completed. It does not result in hepatotoxicity or any other serious adverse reactions up to three times the maximum recommended daily dosage (12 grams/day).
5. The clinical study in combination with a non-addictive analgesic drug for management of moderate-to-severe pain has completed enrollment of patients undergoing knee replacement. The purpose of development is to verify: (a) SNP-810 has no hepatotoxicity when used in new combination; (b) The combination of non-addictive analgesics can achieve the highest level of pain relief as shown by WHO Analgesic Ladder; (c) Both In- & out-patients can achieve analgesic efficacy by oral administration without using IV injections or nacrotic controlled drugs. Enrollment of 36 patients is completed, and subsequent data processing, statistical analysis and report preparation are ongoing.
6. For replicating the clinical study testing the dosages exceeding triple recommended label dosage of acetaminophen in the US, the acute GLP toxicology study in rats has been completed in accordance with US FDA requirements, and the acute GLP toxicology study in dogs is ongoing. 

Toxicological studies

1. Toxicology CROs, such as Charles River Laboratories and QPS, have performed functional tests on mice and proved that SNP-810 has high liver safety.
2. Outsource to a foreign toxicology CRO, Charles River Laboratories, to perform acute GLP toxicology study in dogs.

Licensing activities

1. Company A: The high liver safety property of SNP-810 has been verified by a third party, and the animal testing results have been provided to Company A.
2. Company B: Confirmation study is currently underway.