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news.Vascular products developer Angiogenix has revealed that Acclaim, its product candidate for the prevention of nitrate tolerance in chronic stable angina patients, failed to meet its primary endpoint in a phase II trial.
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Patients in the study were randomized to receive either Acclaim, a proprietary combination of isosorbide mononitrate plus L-arginine, or conventional standard of care – nitrate alone therapy.
Both groups were tested against the primary endpoint of treadmill walking time (TWT) until moderate angina occurred. Secondary endpoints included time to ST-segment depression and time to first onset of angina. Other endpoints included the need for rescue medication and number of anginal episodes.
Results demonstrated that Acclaim did not meet its primary endpoint of increased TWT with statistical significance.
Although the primary endpoint was not met, the analysis of the data revealed positive, non-statistically significant trends in time to onset of angina and ST-segment depression.
“Angiogenix continues to believe Acclaim has potential for solving this important problem, thus providing significant benefits for angina patients,” said Ed Jennings, CEO at Angiogenix. “We will use these data as we design our next study to ensure that the L-arginine plasma concentrations required to prevent tolerance are achieved and maintained.”