Results for FX 006 in osteoarthritis of the knee study- Flexion Therapeutics

Flexion Therapeutics, Inc.reported top-line results from the first of two pivotal clinical trials of its lead drug candidate FX 006 in patients with moderate to severe osteoarthritis (OA) knee pain.

In this trial, 40 mg of FX 006, compared to placebo (saline), demonstrated statistical significance in average pain relief over weeks 1 through 12 (p = 0.0012; 2-sided) and over weeks 1 through 24 (p = 0.0209; 2-sided). At weekly time points, 40 mg of FX 006 also demonstrated superiority to placebo in pain relief beginning at week 1, continuing to week 11 and also at week 13 (p < 0.05 at each time point; 2-sided). The primary endpoint of the trial, superiority in pain relief at 12 weeks, did not reach statistical significance (p = 0.0821; 2-sided). A pre-specified, commonly applied sensitivity analysis (Baseline Observation Carried Forward/Last Observation Carried Forward (BOCF/LOCF)) that addresses patient dropouts, however, did demonstrate statistical significance for the primary endpoint at 12-weeks (p = 0.042). Overall, the 40 mg dose of FX 006 performed better than the 20 mg FX 006 dose. In particular, the 40 mg dose conferred more durable pain relief. The frequency of treatment-related adverse events across the three groups (FX 006 40 mg, FX 006 20 mg and placebo) was comparable, and no drug-related serious adverse events were observed in the trial. Adverse events thought to be at least possibly related to study drug as assessed by the investigator were less frequent for FX 006 than placebo.

Comment:President and CEO Michael Clayman said in a statement from Flexion that the company is confident in the 40mg dose of FX 006 and it plans to seek FDA approval based on all of the available data for the drug, including results from the ongoing pivotal Phase III study and a prior Phase IIb dose-finding study.