We currently have several ongoing clinical trials for the development of our novel, non-opioid chronic pain therapeutics.
Osteoarthritis (OA) is the most common form of arthritis, affecting tens of millions of people worldwide. The chronic pain associated with OA, in particular the severe pain experienced by nearly a quarter of OA sufferers, is one of the most common reasons for chronic opioid prescriptions. OA occurs when the protective cartilage on the ends of the bones wears down over time, and the bone around the joints hardens and form edges. These changes cause pain, swelling and problems moving the joint. An inflammatory process occurs, and cytokines (proteins) and enzymes develop that further damage the cartilage. Although it can damage the majority of joints in the body, the disorder most commonly affects joints in hands, knees, hips and spine. OA can cause pain severe enough that patients experience difficulty with simple daily movements such walking, climbing stairs or even rising from a chair. Despite currently available therapies, many patients still suffer with chronic moderate to severe pain. For some, there is the option for total joint replacement to manage the painful condition. But for many, surgery is not an option due to age, or other conditions, such as lack of adequate support and long recovery periods.
Positive results from the TRIUMPH Phase 2b trial have been recently presented at several leading medical conferences. The VICTORY-1 Phase 3 double-blind, placebo-controlled trial in patients with moderate to severe knee OA commenced in February 2018.
The U.S. FDA granted CNTX-4975 Fast Track designation for the treatment of pain associated with knee OA in January 2018.
OA also affects pets, in particular dogs, in a very similar way to humans. Current treatment options are designed to control signs and symptoms of the disease, not to cure it. As such, for many dogs with unmanageable OA pain, owners are forced to contemplate euthanasia for their pet in order to end his/her suffering.
The previous COAST trial, which investigated CNTX-4975 for the treatment of osteoarthritis in pet dogs, identified a dose for future pivotal studies. The STEPS trial is underway as a double-blind, placebo-controlled, parallel group, single injection study to confirm the dose and refine study design before starting the pivotal efficacy trial.
The VICTORY-1 Phase 3 double-blind, placebo-controlled trial in patients with moderate to severe knee OA is due to commence in early 2018.
Double-blind, placebo-controlled trial in canines with osteoarthritis has completed enrollment and is no longer recruiting patients.
Morton’s neuroma involves a thickening of the tissue around one of the nerves leading to the toes. This can cause a sharp, burning pain in the foot and the toes may sting, burn or feel numb. Repetitive strain on the front of the foot such as wearing high heeled shoes or long-distance running have been linked to the development of Morton's neuroma. Some people experience relief from Morton’s neuroma by switching to lower-heeled shoes with wider toe boxes or by using orthotics. For those not responding to these approaches, the current standard of care is corticosteroid injections. If these fail, the only option is surgery to remove the nerve containing the neuroma, however, the area where the nerve has been removed may be left permanently without feeling 1.
There are currently no FDA approved treatments for Morton's neuroma. The U.S. FDA has granted CNTX-4975 Orphan Drug and Fast Track designations for the treatment of Morton's neuroma pain.
This Phase 2 double-blind, placebo-controlled trial in patients with Morton’s neuroma has completed enrollment and is no longer recruiting patients.
For more information, visit clinicaltrials.gov.