Flexion Therapeutics Ltd

The company’s broad and diversified portfolio of small molecule product candidates addresses the OA pain treatment spectrum, from moderate to severe pain, and provides it with multiple unique opportunities to achieve its goal of commercializing novel, patient-focused pain therapies.

Its lead product candidate, FX006, is a first-in-class injectable intra-articular, meaning “in the joint,” sustained-release treatment for patients with moderate to severe OA pain. FX006 combines a commonly administered steroid, triamcinolone acetonide, with poly lactic-co-glycolic acid to provide sustained therapeutic concentrations in the joint and persistent analgesic effect. In a completed Phase 2b dose-ranging clinical trial, FX006 has demonstrated clinically meaningful and significantly better pain relief compared to the current injectable standard of care. Before pursuing Phase 3 clinical development, the company expects to initiate a confirmatory Phase 2b clinical trial in the second quarter of 2014 to further identify a safe and well-tolerated dose of FX006 that demonstrates superior pain relief to placebo. It is also currently conducting a synovial fluid pharmacokinetic clinical trial to measure the duration that FX006 remains in the joint, which will inform it on the dosing regimen for a planned repeat dose safety clinical trial to assess when repeat dosing of FX006 can be safely administered.

Flexion is developing two additional product candidates, FX007 for post-operative pain and FX005 to treat end-stage OA patients. FX007 is a locally administered TrkA receptor antagonist for persistent relief of post-operative pain, including in patients who have received total joint replacement, also referred to as total joint arthroplasty, or TJA. The company plans to file an Investigational New Drug application for FX007 in the first half of 2014. FX005 is an intra-articular, sustained-release p38 MAP kinase inhibitor which has both analgesic and anti-inflammatory effects, and has successfully completed a placebo-controlled Phase 2a proof of concept clinical trial demonstrating significant pain relief in OA patients.

The company has worldwide commercialization rights to all of its product candidates. It intends to market its products in the United States through its own sales force that will target specialty physicians, including orthopedists and rheumatologists. Outside of the United States, it is exploring selective partnerships with third parties for the development and commercialization of its product candidates.