Flexion’s strategy is to build a robust pipeline of locally administered therapies to address musculoskeletal conditions, with an initial focus on osteoarthritis.
(helper-dependent adenovirus [HDAd] vector with Interleukin-1 Receptor antagonist gene)
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 osteoarthritis. 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 first-in-human clinical trials in 2019.
FX301 is a locally administered NaV1.7 inhibitor formulated for extended-release from a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of post-operative pain. FX301 has the potential to provide effective pain relief while preserving motor function. The company anticipates initiating FX301 clinical trials in 2021.