Flexion enrols first subject in Phase III trial of zilretta

3rd January 2019 (Last Updated January 3rd, 2019 00:00)

Flexion Therapeutics has enrolled the first patient in a Phase III clinical trial to examine the safety and efficacy of zilretta (triamcinolone acetonide extended-release injectable suspension) for the treatment of patients with hip osteoarthritis (OA).

Flexion enrols first subject in Phase III trial of zilretta
X-ray of hips showing narrowing of joint space, osteophyte production and increased density of bone end. Credit: Wellcome Photo Library. Wellcome Images.

Flexion Therapeutics has enrolled the first patient in a Phase III clinical trial to examine the safety and efficacy of zilretta (triamcinolone acetonide extended-release injectable suspension) for the treatment of patients with hip osteoarthritis (OA).

Hip OA is a degenerative disease with no cure that is estimated to affect nearly a quarter of the US population in their lifetime.

Flexion aims to enrol 440 patients with hip OA pain as part of the double-blind, placebo-controlled trial.

Patients will be randomised in 1:1 ratio into one of two treatment groups to receive a single intra-articular (IA) injection of either zilretta or placebo.

After being treated with the first injection of zilretta or placebo, patients will be assessed at weeks 12, 16, 20 and 24 to determine the clinical requirement of a second IA injection.

"We believe zilretta may be able to play an important role in helping these patients find meaningful pain relief."

Patients eligible for a second injection will be treated with open-label zilretta at the time of recurrent symptoms before being monitored for 12 weeks.

The remaining patients who will not receive a second injection will be observed for up to 24 weeks after their first injection.

Primary objective of the trial is the scale of pain relief against placebo as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index A (WOMAC A) subscale at week 12.

Flexion Therapeutics president and CEO Michael Clayman said: “Like OA of the knee, OA of the hip is a serious disease that can profoundly affect one’s quality of life.

“These impacts are compounded by the fact that there are so few non-surgical treatment options available to manage OA hip pain, and we believe zilretta may be able to play an important role in helping these patients find meaningful pain relief.

“We look forward to reporting the Phase III results with the expectation that the trial will read out in 2020.”

Flexion also intends to begin new Phase II studies of zilretta later this year.