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news.US-based pharmaceutical firm Flexion Therapeutics has dosed first patient in a confirmatory Phase IIb clinical trial of its novel, non-opioid, sustained-release, intra-articular (IA) formulation of triamcinolone acetonide (TCA) 'FX006' as a treatment for relieving pain associated with Osteoarthritis (OA) of the knee.
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The trial is designed to further evaluate the safety, tolerability and efficacy of certain doses of FX006.
FX006 is designed to offer prolonged pain relief for the treatment of mild to moderate OA of the knee, while avoiding untoward systemic effects related with immediate release steroids.
Flexion Therapeutics president and CEO Michael Clayman said the company believes that the superior performance of FX006 in a completed Phase IIb trial against active comparator –reported at the 2013 American College of Rheumatology Annual Scientific Meeting — illustrates the potential of this product candidate to make a meaningful difference for the many patients who suffer the often debilitating pain of osteoarthritis of the knee.
"Our newly initiated Phase 2b confirmatory trial is powered to provide pivotal data for FX006 compared to placebo," Clayman said.
The company intends to receive topline data from the trial in the first half of 2015 and, if positive, the data would set the stage for Phase III development in 2015.
In the Phase IIb confirmatory trial, about 300 patients will be randomized and treated with a single injection of either 20mg or 40mg of FX006 or placebo and will be evaluated for 20 weeks.
The trial’s primary outcome measure is the weekly mean of the average daily pain intensity scores as assessed using an 11-point numerical rating scale, while secondary endpoints include Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC(R)), patient global impression of change, clinical global impression of change and responder status.
Simultaneously, the company is carrying out a trial of FX006 synovial fluid pharmacokinetics in patients with OA to better characterize local exposure and assist in setting the interval for repeat dosing.
Topline data from this trial are expected to be released in the second quarter of 2014.
Image: MRI of osteoarthritis in the knee, with characteristic narrowing of the joint space. Photo: courtesy of Scuba-limp