September 18, 2014
By Mark Terry, BioSpace.com Breaking News Staff
The U.S. Food and Drug Administration has contacted Flexion Therapeutics, Inc. to let them know a clinical hold had been put on patient enrollment and dosing for an ongoing Phase 2b clinical trial, the company said Thursday.
The trial is evaluating FX006 in patients with osteoarthritis (OA) of the knee.
Flexion held a conference call and webcast this morning to discuss the clinical hold. The company had not received written notice of the hold from the FDA, but says the hold is the result of a single case of an infection of in one of the patient’s knee joints. The patient was hospitalized and a procedure was performed to drain the knee and placed on intraveneous antibiotics. They received a call from the FDA in the afternoon of Sept. 17.
According to statements made during the conference call, the FDA also had some concerns around the sterility of FX006. It is not related in any way to the efficacy of the drug. About 150 patients had been enrolled in the study. The drug is injectable. The company is responding quickly to the hold and will be turning over data to the FDA concerning the compound’s safety profile and sterility data.
Company President and CEO Mike Clayman said in the call, “In our clinical development program to date we have treated over 300 patients with FX006, including approximately 100 FX006 treated patients in the current Phase 2b study. The predominant adverse events observed have been musculoskeletal signs and symptoms of the injected knee and these have generally been mild to moderate in severity. In the current Phase 2b trial and in previously completed clinical trials of FX006 we have never seen infections of the knee joint until this recent event.”
FX006 is an intra-articular sustained release steroid. In addition to this product, Flexion has two other candidates, FX007, a locally administered TrkA receptor antagonist for post-operative pain, and FX005, an intra-articular, sustained-release p38 MAP kinase inhibitor for end-stage OA patients. The company’s products, in general, are designed to deliver anti-inflammatory and pain relief directly to the site of the disease.
Earlier this month Burlington, Mass.-based Flexion announced it had been issued a patent for FX006 (No. 8828440), entitled “Corticosteroids for the Treatment of Joint Pain.”
In the patent, FX006 is described as an injectable formulation comprised of controlled or sustained-release microparticles that contact TCA in a poly(Lactic-co-glyolic) acid co-polymer (PLGA) matrix.
