Each of Flexion's compounds is directed against a distinct, validated target, and all have been formulated for prolonged release within the joint. Individually, they provide unique benefits; together, they address the spectrum of unmet medical need in OA, from an anti-inflammatory for the treatment of early disease (FX006), to an anti-inflammatory that incorporates analgesic effects for the treatment of more advanced disease (FX005), to a powerful non-narcotic analgesic for the treatment of refractory end-stage pain (FX007).
Flexion's current pipeline of best-in-class intra-articular (IA) therapies addresses the full spectrum of unmet medical need in OA.
FX006
Development Stage: In Phase 2b dose ranging (224 patients)
- Proven anti-inflammatory
- Disease-modifying potential
- Prolonged efficacy
- Absence of systemic steroid side effects
FX006 is Flexion's novel, proprietary, sustained-release formulation of triamcinolone acetonide for the treatment of mild to moderate OA of the knee. It is designed to provide prolonged pain relief while avoiding untoward systemic effects associated with steroids as front-line therapy. In preclinical models of OA, FX006 demonstrates superior efficacy to immediate release steroids and demonstrates beneficial effect on structural progression. FX006 is entering a phase 2b dose ranging study and is poised to move rapidly to commercialization.
FX005
Development Stage: Completed a Phase 2a (PoC) study (PDF)
- Anti-inflammatory, analgesic
- Disease-modifying potential
- Novel mechanism of action
FX005, Flexion's novel, proprietary inhibitor of p38-MAPK (a clinically validated target in pain and inflammation) is positioned as second line therapy (following IA steroids) for the treatment of moderate OA of the knee. In the Phase 2a study FX005, demonstrated significant pain relief over placebo at four weeks. Top-line data showed FX005, delivered intra-articularly to the knee, was well-tolerated and resulted in prolonged improvement in joint pain and function throughout the 12-week duration of the study. These are the first-ever clinical results demonstrating the efficacy of a p38 MAP kinase inhibitor in osteoarthritis patients.
FX007
Development Stage: Pre-clinical
- Powerful non-narcotic analgesic
- Novel mechanism of action
FX007 is Flexion's novel, proprietary antagonist of TrkA, a neuronal receptor resident in the articular tissues. In the pathophysiology of osteoarthritis, the binding of Nerve Growth Factor (NGF) to TrkA is associated with neuronal sensitization and pain, and in clinical studies, systemic blockade of NGF has demonstrated a profound effect on the pain of OA — in fact the largest effect seen in any clinical study of OA. FX007 prevents the activation of TrkA by NGF and local delivery of FX007 has the potential to safely address the intractable pain associated with end stage OA, including the pain experienced by patients awaiting joint replacement.