Centrexion Therapeutics has begun VICTORY-1, a Phase III clinical trial of CNTX-4975 for the treatment of chronic moderate-to-severe pain due to knee osteoarthritis (OA).
CNTX-4975 is a new non-opioid therapy that can be injected directly into a painful joint. It is claimed to provide fast-acting and long-lasting pain relief without the risk of abuse and addiction.
The randomised, double-blind, placebo-controlled, 52-week VICTORY-1 trial will examine the safety and efficacy of a single injection of CNTX-4975 in patients with chronic moderate-to-severe OA knee pain.
It expects to enrol around 325 patients aged 40 to 95 years.
The trial’s primary endpoint is a change in pain when walking measured at week 12. It will be assessed on the numeric pain rating scale (NPRS).
Secondary endpoints of the trial comprise a change in pain when walking and a change in average knee stiffness and function measured at week 12.
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Other secondary endpoints will include a change in knee pain, knee stiffness and function; patient global impression of change (PGIC) for a treated knee; and quality of life measures, which will all be measured consistently up to week 52.
Centrexion Therapeutics CEO Jeffrey Kindler said: “Chronic OA pain is an important and rapidly growing public health issue.
“To improve the quality of life for the millions of people suffering from this condition, we must continue to explore novel approaches that lead to effective and safe therapeutic alternatives.”
Kindler further noted that CNTX-4975 could help avoid the significant challenges, side effects and potential risks that are reported in other available therapies for OA pain.
OA is the most common form of arthritis, which is estimated to affect roughly 14 million people in the US.