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BELLUS Health announces update on the Phase III trial for KIACTA(tm) in AA amyloidosis presented at the XIII International Symposium on Amyloidosis
- Demographics and baseline characteristics comparable to patient population in first Phase...
About this update from Bluenergies Ltd.
[{"type":"text","content":"\n\n\n\n\n\n- Demographics and baseline characteristics comparable to patient\n population in first Phase III study -\n\n\nLAVAL, QC, May 10, 2012 /CNW/ - BELLUS Health Inc. (TSX: BLU) (\"BELLUS\n Health\" or the \"Company\") today announced a study update and\n preliminary blinded data on patient demographics and baseline\n characteristics for the ongoing Phase III trial to confirm the safety\n and efficacy of KIACTATM (eprodisate) in the treatment of AA amyloidosis. Bellus' strategic\n partner for KIACTA™, Celtic Therapeutics, provided the update as part\n of its participation in the XIII International Symposium on Amyloidosis\n at the University Medical Center of Groningen in The Netherlands.\n\n\n\"Preliminary, blinded data from our ongoing Phase III confirmatory trial\n demonstrates that the baseline characteristics and demographics of the\n 78 patients profiled to date are very similar to the first Phase III\n study we completed,\" said Dr. Denis Garceau, Global Project Leader for\n Celtic Therapeutics for the KIACTA™ Phase III trial, and Senior Vice\n President, Drug Development of Bellus Health. \"These data confirm that\n we constructed an effective trial design based on the strong results of\n our first Phase III study. We have enrolled 90 patients so far and\n expect to complete this process by the second half of next year.\"\n\n\nThe Phase III study is an event-driven trial that is being conducted in\n approximately 28 countries, across 79 sites. The current trial is being\n run to confirm the results of the prior Phase III clinical trial, which\n demonstrated statistically significant primary efficacy endpoints (p\n value = 0.025) and a clean safety profile. The study will conclude when\n 120 events are attained.\n\n\nImprovement in Design of Phase III Confirmatory Trial\n\n\n \n\n\nFirst Phase III Study\n\n\nPhase III Confirmatory Study\n\n\nDuration\n\n\nTwo years\n\n\n120 events\n\n\nNumber of patients\n\n\n183\n\n\n230\n\n\nEntry criteria\n\n\nProteinuria >1g/d or CrCl <60 ml/min\nand\nCrCl >20 ml/min\n\n\nProteinuria >1g/d\nand\nCrCl >25 ml/min\n\n\nP value\n\n\n0.01 (power ~ 80%)\n\n\n0.05 (power ~90%)\n\n\nPrimary Composite Endpoint\n(Time to earliest event)\n\n\n100% increase in SCr; or\n50% decrease in CrCl; or\nESRD/dialysis; or\nDeath\n\n\nPersistent 80% increase in SCr; ...