Pain relief and fever reduction (Novel acetaminophen formulation 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 clinical trials have been completed.
2. The results of the SNP-810 clinical study, testing the dosages reaching triple of the recommended label dosage of acetaminophen, were disclosed, and have provided direct evidence in humans that SNP-810 has high liver safety.
3. The results of the SNP-810 clinical study in combination with a non-addictive analgesic drug for management of moderate-to-severe pain in patients undergoing knee replacement showed that no hepatotoxicity or serious adverse reactions related to the study drug occurred. The combination therapy demonstrated a significant synergistic effect in relieving severe pain.

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%, it is expected to reach US$14.07 billion in 2031. 

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. 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.
3. 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).
4. 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 was completed with no clinically significant hepatotoxicity or serious adverse reactions related to the investigational drug observed during the study. The combination therapy has shown a significant synergistic effect in relieving severe pain.
5. 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.