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Diabetic Kidney Disease

Patient Medical Areas

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.

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