FX006 Pivotal Ph 2b Data September , 2015

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Presentation transcript:

FX006 Pivotal Ph 2b Data September , 2015

Pivotal Phase 2b Study Design Pain measured on 0 – 10 Numeric Rating Scale 0 = no pain; 10 = pain as bad as you can imagine Baseline index knee pain between 5 and 9 Primary outcome measure - weekly mean of average daily pain intensity score Primary endpoint: 12 week landmark analysis vs. placebo Patients were evaluated for a total of 24 weeks Secondary outcome measures Pain by WOMAC A (pain), B (stiffness), C (function) Time to onset of pain relief Responder status Patient and clinical global impression of change Rescue medication consumption Completed enrollment February 2015 Ph 2b Pivotal Study (n=300) 5ml IA single-dose knee injection Location: US and Canada - 45 Centers -100 OA patients on FX006 (40mg) -100 OA patients on FX006 (20mg) -100 OA patients on Placebo (saline) FX006 40mg (100) FX006 20mg (100) Placebo Saline (100) Study Objective Identify a safe and well tolerated dose of FX006 which demonstrates superiority to placebo in magnitude of pain relief at 12 weeks 2

Durable Pain Relief with Substantial Separation from Placebo