Ironwood Pharma (IRWD) Announces Presentation of Additional Data from ZURAMPIC Phase 3s

November 14, 2016 7:09 AM EST

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Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD) presented efficacy and safety data from two Phase III extension studies of ZURAMPIC (lesinurad), as well as pooled analyses from the two extension studies and from the three pivotal Phase III ZURAMPIC clinical trials, in four poster presentations at the American College of Rheumatology (ACR) Annual Meeting in Washington, D.C.

ZURAMPIC is FDA-approved as a once-daily oral tablet to be taken in combination with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with an XOI alone. ZURAMPIC is not recommended for the treatment of asymptomatic hyperuricemia and should not be used as monotherapy.

The FDA approval of lesinurad was based upon three pivotal Phase III trials: the CLEAR 1 and CLEAR 2 trials, in which patients were randomized to receive either 200 mg lesinurad plus the XOI allopurinol, 400 mg lesinurad plus allopurinol, or placebo plus allopurinol for 12 months, and the CRYSTAL trial, in which patients were randomized to receive 200 mg lesinurad plus the XOI febuxostat, 400 mg lesinurad plus febuxostat, or placebo plus febuxostat for 12 months. The two lesinurad extension studies, which were open-label, further evaluated the safety and efficacy of lesinurad plus an XOI over a 12-month extension period. The CLEAR extension study enrolled patients from the CLEAR 1 and CLEAR 2 trials, with patients who received lesinurad plus allopurinol in those trials continuing their treatment, while patients who previously received placebo were randomized to a lesinurad plus allopurinol treatment arm. The CRYSTAL extension study enrolled patients from the CRYSTAL trial, with patients who received lesinurad plus febuxostat in that trial continuing their treatment, while patients who previously received placebo were randomized to a lesinurad plus febuxostat treatment arm.

Data are to be presented on Sunday, November 13, from 9:00 a.m. to 11:00 a.m. Eastern Time as follows:

  • Examination of Serum Uric Acid (sUA) Lowering and Safety With Extended Lesinurad + Allopurinol Treatment in Subjects With Gout (abstract #208), to be presented by Kenneth G. Saag, M.D., M.Sc., University of Alabama at Birmingham, during the Metabolic and Crystal Arthropathies Poster Session I: Clinical Practice. This analysis found that patients treated with lesinurad plus allopurinol in the CLEAR 1 and CLEAR 2 trials who continued treatment in the CLEAR extension study maintained target sUA levels over the full two years. Additionally, an increased proportion of patients who received placebo in CLEAR 1 and CLEAR 2 reached target sUA levels after crossing into the CLEAR extension study and receiving treatment with lesinurad plus allopurinol. The data from this extension study identified no new safety signals in patients continuing lesinurad plus allopurinol treatment in the CLEAR extension study relative to the safety profile observed for those receiving lesinurad plus allopurinol in CLEAR 1 and CLEAR 2.
  • Clinical Response of Tophus and Flares to Extended Use of Lesinurad in Combination With a Xanthine Oxidase Inhibitor in Patients With Gout (abstract #209), to be presented by Thomas Bardin, M.D., Lariboisière Hospital, Paris, France, during the Metabolic and Crystal Arthropathies Poster Session I: Clinical Practice. This analysis of pooled data from patients receiving lesinurad plus XOI in the CLEAR 1, CLEAR 2 or CRYSTAL trials who continued treatment in the CLEAR and CRYSTAL extension studies examined the impact of treatment of lesinurad plus XOI on tophi and flares. The pooled analysis found that patients treated with lesinurad plus an XOI for up to two years exhibited continued increases in the rate of complete resolution of tophi and reduction in tophus area, as well as decreased rates of gout flares.
  • Renal Safety of Lesinurad: A Pooled Analysis of Phase III and Extension Studies (abstract #206), to be presented by Robert Terkeltaub, M.D., University of California, San Diego, during the Metabolic and Crystal Arthropathies Poster Session I: Clinical Practice. In this study, renal-related and kidney stone safety data were pooled from patients enrolled in the CLEAR 1, CLEAR 2 and CRYSTAL trials taking either lesinurad 200 mg plus XOI or lesinurad 400 mg plus XOI as well as patients enrolled in the CLEAR and CRYSTAL extension studies. These pooled safety data were compared against patients taking XOI alone in the three pivotal Phase III trials, to evaluate the impact on renal safety of extended lesinurad plus XOI treatment. The study concluded that, except for a higher rate of serum creatinine elevations, the majority of which resolved during the study period, lesinurad at the approved dose of 200 mg once-daily combined with an XOI demonstrated a comparable rate of renal adverse events to XOI alone. There was no clinically relevant increase in these adverse events with the extension of treatment beyond one year.
  • Integrated Safety of Lesinurad, A Novel Uric Acid Reabsorption Inhibitor for the Treatment of Gout (abstract #207), to be presented by Michael A. Becker, M.D., University of Chicago, during the Metabolic and Crystal Arthropathies Poster Session I: Clinical Practice. This study integrated safety data for lesinurad based on patients who completed the CLEAR 1, CLEAR 2 and CRYSTAL trials taking either lesinurad 200 mg plus XOI or lesinurad 400 mg plus XOI, as well as the CLEAR and CRYSTAL extension studies. The integrated study concluded that lesinurad at the FDA-approved dose of 200 mg once-daily combined with an XOI demonstrated a consistent, acceptable safety profile, with rates of treatment-emergent adverse events comparable to XOI alone and lower than with lesinurad 400 mg once-daily plus XOI. There were no new safety concerns identified in the extension studies.


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