Flexion’s strategy is to build a robust pipeline of locally administered therapies to address musculoskeletal conditions, with an initial focus on osteoarthritis (OA).
FX101 (fluticasone ER)
FX101 utilizes Flexion’s proprietary microsphere technology to create an extended-release formulation of fluticasone within a poly lactic-co-glycolic acid (PLGA) matrix. The approach builds on the company’s deep experience and expertise in developing and commercializing microsphere-based, extended-release therapies. The company is assessing whether FX101 holds the potential to deliver active OA pain relief for at least six months. FX101 has been designed with the goal to provide extended, locally administered analgesia, while potentially avoiding systemic side effects. Pending successful results from our ongoing preclinical studies, we intend to initiate Good Lab Practice (GLP) toxicology studies in 2018.
FX201 is a locally administered gene therapy which is designed to stimulate the production of an anti-inflammatory protein, interleukin-1 receptor antagonist (IL-1Ra), whenever inflammation is present within the joint. Inflammation is a known cause of pain, and chronic inflammation is thought to play a major role in the progression of OA. By persistently suppressing inflammation, FX201 may both reduce pain and modify the disease. Based on strong preclinical data, a single injection of FX201 could potentially enable expression of IL-1Ra in an osteoarthritic joint for at least a year, and it may hold the potential to be disease modifying. Pending successful results from preclinical studies, Flexion aims to initiate a Phase 1 clinical trial in 2019.