Sometimes good news for a company and good news for medical treatments are underappreciated. A company named Sorrento Therapeutics has been testing a drug called Resiniferatoxin (RTX), which is a non-opioid treatment being tested for knee pain within a population of osteoarthritis patients. This could be a big step forward for those who suffer from knee pain from osteoarthritis even though the final outcome will still take time to play out.
Sorrento, which has been more recently known for studies in cancer and COVID-19 diagnostics and treatments, has received U.S. Food and Drug Administration (FDA) clearance to move Resiniferatoxin (RTX) into a Phase 2 clinical trial. Where this clinical trial will sound different is that Sorrento’s Phase 2 study is looking to determine a recommended dosing of the drug for its Phase 3 trial. With the Phase 2 study and the Phase 3 also using larger patient populations, RTX seemed to perform well in its smaller and earlier trials.
What Sorrento has already released is the data showing that its Phase 1b trial did demonstrate RTX was safe for a single intra-articular administration without dose limiting toxicity at any doses tested up to 30 ug. The data further demonstrated significant RTX efficacy for long-term control of refractory osteoarthritis pain and that it offered sustained pain relief lasting beyond 6 months.
Moderate-to-severe osteoarthritis of the knee pain, or OAK, may ultimately be only a smaller target if this drug proves to be successful in treating larger populations. The Centers for Disease Control and Prevention (CDC) data from 2015 showed some 15 million adults reported severe joint pain due to arthritis. The CDC has further projected that the arthritis population will also grow over time as the population grows and ages.
Sorrento’s press release indicated that the Phase 2 trial, in light of the durability of OA pain relief response that RTX has previously demonstrated, will also include an active comparator that is an injectable corticosteroid. Sorrento also indicated that RTX may see accelerated international registration in Europe.
The prior Phase 1b study had been designed to follow patients for 84 days in its primary endpoint. The company had also given these patients an option to be followed for up to a year, and its assessment was that “a large proportion of the patients followed” showed that their pain relief was sustained beyond all time points assessed through a full year of being monitored.
More data on prior studies can be seen here at the ClinicalTrials.gov site under the National Institutes of Health and that also showed that the trial data were from U.S. sites in Boston, Los Angeles, Miami and Houston. More data can be seen on Sorrento’s other pipeline candidates as well.