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news.Biotech firm Exelixis has presented disappointing data from its randomized, double-blind, placebo-controlled Phase II clinical trial of XL784 in subjects with albuminuria due to diabetic nephropathy.
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A total of 125 subjects were enrolled into this study. XL784 (200mg once daily for 12 weeks) was compared to placebo in subjects with macro-albuminuria who were being treated concurrently with an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB). The primary endpoint was the reduction from baseline in the urinary albumin to creatinine ratio (ACR) at Week 12.
After 12 weeks of treatment with XL784 the baseline normalized ACR (end of treatment/baseline ACR) in the XL784 group was 9.9% lower than that in the placebo group (not significant). There was a clinically relevant mean ACR reduction from baseline of 23% (p=0.0027) in subjects randomized to XL784. The change in glomerular filtration rate (GFR) at Week 12 was -2.5 ml/min/1.73m2 in the XL784 group and -6.2 ml/min/1.73m2 in the placebo group (p=0.077).
XL784 was generally well-tolerated, with fewer subjects reporting adverse events in the XL784 group (77%) than in the placebo group (85%). Serious adverse events (SAEs) were reported by 9.5% of subjects in the XL784 group and by 11% of subjects in the placebo group. No SAEs in the XL784 group were considered to be related to study drug.