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Diabetic Kidney Disease

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May 5, 2014

Concert Pharmaceuticals issued results of a phase II trial of CTP-499 in patients with diabetic kidney disease. The placebo-controlled, multi-center trial involved three parts: a double-blind, randomized, parallel, two-arm, placebocontrolled study evaluating urinary albumin to creatinine ratio (UACR) of 600mg CTP-499 twice daily for 24 weeks (151 of 182 patients enrolled completed part 1); an optional blinded extension study in which all patients who completed part 1 were eligible to continue receiving 600mg of CTP-499 or placebo twice daily for an additional 24 weeks (123 of 143 patients enrolled completed part 2); up to 48 weeks of open-label treatment and receive 600mg of CTP-499 twice daily, currently ongoing. The mean serum creatinine level in the 65 patients receiving CTP-499 increased by 0.13mg/dL compared to an increase of 0.21mg/dL in the 58 patients receiving placebo through the 48 weeks of treatment (p = 0.057), reflecting a 38% improvement. At 48 weeks, UACR in patients receiving CTP-499 increased 24mg/g from baseline compared to 223mg/g increase in patients receiving placebo (p = 0.097). Treatment with CTP-499 resulted in 52% less urinary fibronectin (p = 0.0081) and 18% less plasma collagen IV (p = 0.022) after 48 weeks compared to placebo. An end-of-phase II meeting request has been submitted to the FDA, and the company intends to discuss a possible phase III.

November 21, 2005

Speedel reported positive results of a phase IIb trial of SPP301 for the treatment of diabetic nephropathy. Study data indicated that the drug significantly reduced urinary albumin excretion rate at all trial doses compared to placebo (p<0.001), with the greatest reductions noted in the two highest trial doses. Total cholesterol scores were also significantly reduced at all doses (p<0.001). Rates of proteinuria were reduced by 30% on top of standard therapy. This randomized, placebo- controlled, double-blind, parallel design study enrolled 286 patients, who received one of 4 doses of SPP301 (5 mg, 10 mg, 25 mg or 50 mg) or placebo once daily for 12 weeks, in addition to standard therapy.

March 7, 2005

Speedel Pharma has reported results of both a phase IIa and phase IIb trial of their investigational endothelin A receptor antagonist SPP301, for the treatment of diabetic nephropathy. Results from the exploratory phase IIa trial yielded evidence of efficacy after 4 weeks of treatment, with clinically relevant 24 hour decreases in proteinuria. Results from the phase IIb trial met their primary endpoint, with the drug producing a statistically significant decrease in albumin excretion rate at 12 weeks, vs. placebo (p<0.05). Proteinuria was also reduced by 30% on top of standard treatment for 55% of patients. This double-blind, randomized, placebo-controlled trial enrolled 286 with diabetic nephropathy, who received one of 4 doses of SPP301 (5 mg, 10 mg, 25 mg or 50mg) or placebo once daily in addition to standard treatment. Based on these results, the company announced plans to initiate a phase III trial of the drug in the second half of 2005.