Fulfilling Unmet Medical Needs

Flexion's current pipeline includes three clinical-stage compounds for osteoarthritis (OA) which were selected based on their promise to progress to Phase 3 testing and commercialization and become first-in-class and best-in-class drugs.

The compounds, FX005, FX006 and FX007, each represent an innovative OA drug candidate, directed against validated inflammatory or pain pathways and formulated for sustained release within the joint after intra-articular (IA) injection.

  • FX005 is a second-line anti-inflammatory IA therapy with potential disease modification capability; an option for patients transitioning from steroids.
  • FX006 is a first-line intra-articular therapy for pain management with preliminary data demonstrating superiority to existing first-line treatments.
  • FX007 is a non-narcotic analgesic for refractory pain in end-stage disease/joint replacement.
Product Preclinical Phase 1 Phase 2 Phase 3 Market
FX005
  • Mechanism: antagonist of a key regulator controlling pain and inflammation cascades
  • Anticipated Utility: anti-inflammatory with disease-modifying capability
 x x x    
FX006
  • Mechanism: proven pain management compound directed at highly validated molecular target
  • Anticipated Utility: potential to become preferred front-line therapy for OA
 x        
FX007
  • Mechanism: antagonist of key target in highly validated, non-narcotic pain pathway
  • Anticipated Utility: provide relief to patients with refractory pain
 x        

Today's standard OA treatments have several limitations. Oral anti-inflammatory drugs have been associated with significant side effects, including gastrointestinal bleeding and cardiovascular risks. Existing classes of IA therapy, while generally well-tolerated, provide limited duration of therapy and/or limited pain relief.

Flexion's IA treatments are designed to address important unmet medical needs in treating osteoarthritis, with initial applications in the knee. Flexion's sustained-release platform enables the delivery of high, local concentrations of therapy at the site of disease while minimizing systemic drug exposures and attendant side effects. This is a significant advantage in the aging OA patient population, with pre-existing co-morbidities such as obesity, diabetes and hypertension.

Flexion's approach has the potential to extend beyond OA. There are many musculoskeletal conditions which are well-suited for sustained-release and targeted therapy. Flexion continues to explore new opportunities to expand the company's pipeline and develop new safer, more effective treatment options.