Horizon Pharma plc Initiates Clinical Trial to Evaluate KRYSTEXXA® (pegloticase injection) with Methotrexate to Enhance Response Rates for People Living with Uncontrolled Gout

DUBLIN, Ireland I September 27, 2018 I Horizon Pharma plc (Nasdaq: HZNP) enrolled the first patient in a clinical trial evaluating the use of KRYSTEXXA® (pegloticase injection) with methotrexate to sustain lower serum uric acid (sUA) levels of people living with chronic gout refractory to conventional therapies – also known as uncontrolled gout – and increase persistence of efficacy on therapy. The clinical trial, Methotrexate to Increase Response Rates in Patients With Uncontrolled GOut Receiving KRYSTEXXA (MIRROR), will enroll approximately 30 patients and is an adaptive design study to evaluate the use of methotrexate as an immunomodulator to meaningfully attenuate an immune response to KRYSTEXXA in adults living with uncontrolled gout.

"In the pivotal clinical trials evaluating KRYSTEXXA 42 percent of patients achieved complete response, maintaining a serum uric acid level of less than six mg/dL over six months," said Jeff R. Peterson, M.D., president, Washington Rheumatology Alliance and a director at Northwest Rheumatism Society and Western Washington Medical Group Arthritis Clinic's clinical research department. "Many biologics have an improved response rate when they are co-prescribed with methotrexate, which works to reduce anti-drug antibodies. It is through research that we gain valuable insights for KRYSTEXXA, an important therapy for patients with progressive signs and symptoms of gout despite the use of oral therapies."

“For patients with uncontrolled gout, it is imperative to rapidly reduce serum uric acid level levels in order to address the disease and its effect on joints, tissues and organ systems,” said John K. Botson M.D., R.Ph., C.C.D., president, Alaska Rheumatology Alliance and rheumatologist, Orthopedic Physicians Alaska. “Methotrexate is very familiar to rheumatologists, and it may allow more patients on KRYSTEXXA to continue over the treatment period.”

Those who meet MIRROR (NCT03635957) eligibility criteria will receive methotrexate 15 mg orally once weekly starting four weeks before and continued through 24 weeks of bi-weekly infusions of KRYSTEXXA. The primary endpoint will be sUA responder rate which is defined as maintaining an sUA level of < 6 mg/dL for at least 80 percent of the time during weeks 10, 12 and 14, as well as having at least one sUA level <5 mg/dL between the first KRYSTEXXA infusion and through week 14. In addition, MIRROR will assess several secondary endpoints including sUA responder rate at weeks 20, 22, and 24 as well as proportion of overall sUA responders at weeks 10, 12, 14, 20, 22, and 24 combined.

“Real-world feedback from the medical community informed our selection of methotrexate as the immunomodulator in this study,” said Paul Peloso, M.D., M.Sc., vice president and therapeutic area head, rheumatology, Horizon Pharma plc. “MIRROR complements two ongoing investigator-initiated trials of KRYSTEXXA with other commonly used immunomodulators, azathioprine and mycophenolate mofetil. This trial is part of our comprehensive clinical strategy to address the burden of uncontrolled gout.”

About Uncontrolled Gout

Gout is a chronic, progressive inflammatory form of arthritis that is caused by excess uric acid in the body and needs to be managed aggressively.1 Patients with uncontrolled gout continue to have abnormally high levels of uric acid and continued symptoms of gout despite the use of conventional therapies. KRYSTEXXA is the only biologic approved by the U.S. Food and Drug Administration (FDA) for the treatment of uncontrolled gout in adult patients. For more information, please visit www.KRYSTEXXAHCP.com.

About KRYSTEXXA

INDICATIONS AND USAGE

KRYSTEXXA® (pegloticase injection) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.

Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

About Horizon Pharma plc

Horizon Pharma plc is focused on researching, developing and commercializing innovative medicines that address unmet treatment needs for rare and rheumatic diseases. By fostering a growing pipeline of medicines in development and exploring all potential uses for currently marketed medicines, we strive to make a powerful difference for patients, their caregivers and physicians. For us, it’s personal: by living up to our own potential, we are helping others live up to theirs. For more information, please visit www.horizonpharma.com, follow us @HZNPplc on Twitter, like us on Facebook or explore career opportunities on LinkedIn.

SOURCE: Horizon Pharma

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