Flexion Therapeutics (FLXN) Announces Presentation of Statistically Significant Zilretta Phase 3 Data in OA of the Knee

November 11, 2016 9:05 AM EST

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Flexion Therapeutics, Inc. (Nasdaq: FLXN) announced that its lead investigational product candidate Zilretta (also known as FX006) demonstrated clinically and statistically significant improvements in an analysis of Phase 3 trial data conducted in patients with osteoarthritis (OA) of the knee. The analysis evaluating the clinical relevance of Zilretta treatment was presented during the 26th American Association of Hip and Knee Surgeons Annual Meeting, taking place November 10-13, 2016.

OA is a type of degenerative arthritis that is caused by the progressive breakdown and eventual loss of cartilage in one or more joints, characterized by pain, swelling, stiffness and decreased mobility of the affected joint. Many current treatment options provide sub-optimal pain control or carry serious side effects. Approximately 40 percent of OA patients are treated with opioid pain medications and about half ultimately require total joint replacement due to disease progression.

“These results demonstrate that FX006 significantly improved pain, stiffness and function in patients with OA of the knee compared to placebo and an immediate-release steroid,” said Andrew Spitzer, M.D., Director of the Joint Replacement Program at Cedars-Sinai Orthopaedic Center. “The persistence of pain relief and functional benefits at 12 weeks, along with data from previous studies showing persistent therapeutic concentrations of steroid in the joint with low systemic exposure, highlight the potential for FX006 to represent a meaningful new treatment option for OA patients.”

  • The Phase 3, randomized, double blind, placebo-controlled, active-comparator trial enrolled 484 patients at 37 centers worldwide. Efficacy was assessed at four week intervals over 24 weeks by:
    • Weekly mean of the average daily pain (ADP) score
    • OA specific measures - WOMAC A (pain), B (stiffness) and C (function)
    • Knee Injury and Osteoarthritis Outcome Score (KOOS) quality of life (QoL) at four-week intervals over 24 weeks
  • As previously reported, Zilretta achieved the primary endpoint of this trial, significantly reducing pain as measured by the weekly mean of the ADP score at week 12 compared to placebo (P<0.0001).
  • Zilretta also achieved statistically significant improvements in WOMAC A, B, and C at Weeks 4, 8, and 12 compared to placebo and immediate-release triamcinolone acetonide (TCA) (P<0.05).
  • In a new post-hoc analysis, Zilretta, but not TCA, consistently demonstrated clinically meaningful effects in pain, stiffness and function by exceeding the Minimum Clinically Important Improvement (MCII) thresholds through 12 weeks as established in the 2013 American Academy of Orthopedic Surgeons (AAOS) Guidelines.
  • No serious drug-related AEs occurred. AEs were balanced across arms and were generally mild.

“We are excited by these data which, we believe, demonstrate that pain relief and functional improvement with Zilretta are rapid, substantial and durable and that the safety profile is comparable to placebo. These attributes support the potential for Zilretta, if approved, to be an important addition to the OA treatment armamentarium,” said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. “We remain on track to submit an NDA to the FDA in December and look forward to providing additional updates on our commercialization objectives in the future.”

About Osteoarthritis of the Knee

While OA is currently being diagnosed at increasingly younger ages, prevalence rises after age 45. In 2015, more than 14 million Americans were diagnosed with OA of the knee. OA represents an enormous burden on the U.S. healthcare system, affecting more than 27 million individuals and accounting for more than $185 billion in annual expenditures. These costs are expected to rise with a predicted increase in OA prevalence, which is expected to affect 67 million Americans by 2030.

Each year, more than five million OA patients in the U.S. receive immediate-release corticosteroid and hyaluronic acid IA injections for knee pain, but these injections generally provide limited relief, and no alternative injectable therapy has been approved in more than a decade.

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