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Oct 2, 2012

Phase III Results Promising for Diabetes, Gaucher, Atrial Fibrillation Drugs

  • Researchers over the past 24 hours published positive data for Phase III clinical trials of three separate drug candidates:

    Johnson & Johnson’s Janssen Research & Development unit presented results of its CANVAS (CANagliflozin cardioVascular Assessment Study), also known as DIA3008, showing canagliflozin substantially lowered blood glucose levels when used as add-on therapy in patients on insulin therapy for type 2 diabetes and considered at greater risk for cardiovascular disease.

    Reductions in fasting plasma glucose were consistent with the primary endpoint for the 100 mg and 300 mg doses of canagliflozin relative to placebo, showing respective glucose reductions of -1.25 and -1.61 millimoles/liter.

    Among secondary efficacy endpoint measures, both the 100 mg and 300 mg doses of canagliflozin reduced patients’ body weight relative to placebo by 1.9% and -2.4%, respectively. Both doses also met secondary endpoints that included reductions in systolic blood pressure and reductions in diastolic blood pressure.

    CANVAS evaluated the efficacy, tolerability, and cardiovascular safety of canagliflozin in 4,330 adult patients with type 2 diabetes considered at elevated risk for cardiovascular disease. Janssen presented results from an 18-week sub-study of 1,718 patients receiving insulin for an average of 7.1 years. Patients randomized to treatment with daily 100 mg or 300 mg canagliflozin, in addition to their usual insulin regimen, had statistically greater A1C reductions at 18 weeks relative to placebo, Janssen said.

    At 300 mg, canagliflozin saw greater incidence of adverse events leading to discontinuation (5.3%) compared to canagliflozin 100 mg or placebo (1.9% each). However, most adverse events were assessed as bring of mild to moderate in intensity, and overall incidence of AEs was balanced across treatment arms.

    The company disclosed results from the CANVAS sub-study at the 48th European Association for the Study of Diabetes (EASD) Annual Meeting. Also disclosed were results from a second Phase III study showing canagliflozin significantly reduced A1C levels compared to placebo when added to ongoing antihyperglycemic therapy in older patients with type 2 diabetes not having adequate glycemic control. In the DIA3010 study, 714 patients with a mean age of 63.6 years were given once-daily doses of canagliflozin (100 mg or 300 mg), or placebo.

    Also today, Sanofi and its Genzyme subsidiary reported that the first Phase III trial of its eliglustat tartrate in previously untreated patients with Gaucher disease type 1 met its primary endpoint of improvement in spleen size. Patients treated with the investigational oral capsule therapy showed an average 28% decrease in spleen volumes compared with a mean increase of 2% in placebo patients, for an absolute difference of 30%.

    All secondary endpoints were also met, including improvements in hemoglobin levels and platelet levels, as well as liver volumes compared with placebo-treated individuals. No serious adverse events were reported in the primary analysis period, and no clinically meaningful differences in related adverse events were reported between the two treatment groups, Sanofi said.

    The trial evaluated the efficacy, safety, and pharmacokinetics of twice-daily dosing of eliglustat tartrate in 40 patients untreated for at least six months. All but one of the 40 completed at least nine months of treatment; the non-finisher discontinued at six months for personal reasons. After the primary analysis period, the 39 finishers all chose to remain on treatment.

    Sanofi and Genzyme released partial results from the Engage clinical trial, with full results planned for presentation at the Lysosomal Disease Network WORLD meeting on Feb. 12–15, 2013, in Orlando, Fla. Eliglustat tartare is designed to provide type 1 Gaucher patients a broader range of treatment options since the current standard of care calls for intravenous infusions of Genzyme’s Cerezyme® (imiglucerase for injection). Genzyme is completing its second Phase 3 registration study, Encore, designed to compare eliglustat tartrate to Cerezyme in type 1 Gaucher adult patients.

    In the third Phase III study, announced yesterday, patients with nonvalvular atrial fibrillation treated with Eliquis® (apixaban) saw consistent reductions in stroke or systemic embolism, major bleeding, and mortality across a wide range of stroke and bleeding risk scores compared to warfarin in the Aristotle trial, according to a study published yesterday in The Lancet.

    The trial evaluated the efficacy and safety of the investigational oral anticoagulant compared with warfarin in preventing stroke or systemic embolism in patients with irregular heartbeat. The subanalysis evaluated data from 18,201 patients in the Aristotle trial, based on their risk of stroke or risk of bleeding. The subanalysis also showed that the reduction in intracranial bleeding with Eliquis compared to warfarin tended to be greater in patients with the highest risk of bleeding than the reduction seen in patients with the smallest risk of bleeding.

    Bristol-Myers Squibb, which discovered Eliquis, and partner Pfizer have sought to develop and commercialize the drug since 2007.


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