Alteon misses Phase IIb endpoint

ALT said its ALT-711 advanced glycosylation endproduct (AGE) cross-link breaker failed to significantly lower systolic hypertension compared to placebo in two Phase IIb trials. The double-blind, U.S. SAPPHIRE and SILVER trials enrolled a total of 768 patients with systolic hypertension with or without left ventricular hypertrophy (LVH). The primary endpoint of both trials was a reduction of systolic blood pressure by office cuff pressure measurement at 210 mg/day -- the highest of four active dose levels of ALT-711.

ALT said the data were "confounded" by a 6-10 mmHg drop in systolic blood pressure across all groups, including placebo, during the two weeks following randomization. In a conference call, ALT said such a drop was "unprecedented" in any other hypertension trials. All patients in the trial received concomitant hypertension medications, and ALT said that increased patient compliance for these drugs in the placebo arm may have contributed to the blood pressure drop in that group. ...