- Centrexion Therapeutics on Tuesday unveiled positive topline results from a Phase 2b trial of its osteoarthritis pain drug and lead candidate, CNTX-4975, which showed the treatment was effective at combating pain associated with the disease.
- The placebo-controlled trial recruited 175 patients suffering from osteoarthritis pain and administered one-time knee injections of CNTX-4975 to 105 of them. Centrexion tested the drug in two different doses, setting reduced pain while walking as the trial's primary endpoint.
- At both doses, the drug significantly outperformed placebo, but did particularly well at the 1.0 mg level. After 12 weeks, 67% of patients receiving that dose reported their pain had been cut in half, while about a quarter said they experienced 90% pain reduction.
The news comes at a time when the private, Boston-based company is looking to make a name for itself in the pain-relief space. The company picked up three candidates — two-preclinical, one in Phase 1 — from Boehringer Ingelheim in March for an undisclosed sum.
Centrexion, led by former Pfizer CEO Jeffrey Kindler, hopes to establish a niche for itself in developing pain medications that don't incorporate opioids.
CNTX-4975 is a testament to that, as it relies on a highly-concentrated form of capcaisin (the compound responsible for the burning sensation felt when eating chili peppers) to alleviate pain. The drug is also being studied as a treatment for canine osteoarthritis pain and Morton's neuroma pain, the latter of which received fast track designation from the Food and Drug Administration in November.
In the human osteoarthritis trial, patients receiving the 1.0 mg dose said they were feeling less pain just days after their injection, and reported statistically significant pain reduction within one week.
The drug met secondary endpoints as well, which included evaluations of knee stiffness and function and the treatment's safety, tolerance and duration. Of note, patients getting the 1.0 mg injection had significantly alleviated pain at the 24-week mark.
What's more, the drug had a safety profile similar to the placebo, and did not trigger any serious side effects.
The results "demonstrate that CNTX-4975 has the potential to provide a non-opioid and non-surgical approach to osteoarthritis pain relief that would allow patients to return to daily activities, such as walking up stairs, that were previously too painful,” Centrexion's Chief Medical Officer said in a Dec. 13 statement.
Centrexion plans to meet with the FDA soon and move its drug into Phase 3 in 2017. The company said it would reveal more data from the the Phase 2b trial at an upcoming conference.