3D1001 is a new-generation cyclooxygenase-2 (COX-2) inhibitor with rapid onset of action and prolonged pain relief to patients with post-surgical dental pain in a clinical study attributable to a favorable PK profile. IND approval was obtained from the NMPA in February 2019. For establishing the IP on compound crystallization, we submitted one Chinese patent application to China National Intellectual Property Administration on December 27, 2022. As of the date of this report, we have completed the manufacture of clinical batch Active Pharmaceutical Ingredient (API) for a Phase I/II clinical trial, and 3D1001 is a potential drug for inflammatory pain and will become our next clinical trial candidate and get closer to the commercial stage.
The advantages of selective COX-2 inhibitors in pain management
Conventional non-steroidal anti-inflammatory drugs (NSAIDs) act on both COX-1 and COX-2 to inhibit downstream prostaglandin E2 (PGE2), prostacyclin (PGI2), and thromboxane A2 (TXA2) pathways to exert their anti-inflammatory and analgesic effects. Because of their non-selective inhibition, traditional NSAIDs are often associated with serious adverse effects in addition to analgesia, with the incidence of gastric and duodenal ulcers 5 to 15 times higher than that in non-users. Selective COX-2 inhibitors can reduce gastrointestinal and cardiovascular side effects by specifically targeting the inflammatory-related PGE2 receptor pathway.