Alteon Inc. will discontinue the SPECTRA trial, a Phase 2b clinical trial for alagebrium, following an interim evaluation of data indicating that the drug has not demonstrated efficacy against uncontrolled systolic hypertension.

While the drug has been observed to be safe and well-tolerated in clinical trials to date, the independent efficacy review committee conducting the interim analysis of SPECTRA found that the data did not indicate a treatment effect of alagebrium against systolic hypertension and that there was a low probability of meeting clinical endpoints by the planned conclusion of the study.

Separately, the Company announced that it had submitted preclinical toxicity data on alagebrium to two divisions of the Food and Drug Administration's (FDA) Centre for Drug Evaluation and Research (CDER). The preclinical toxicity information submitted by the Company was in support of its view that liver alterations previously observed in rats, which led to the Company's voluntary suspension of enrolling new patients into its clinical trials, were related to the male rat metabolism and not to genotoxic pathways.

The Company has been notified by the CDER's Division of Reproductive & Urologic Drug Products that further enrolment in the EMERALD trial, the Phase 2a study of alagebrium in erectile dysfunction, has been placed on clinical hold pending the submission of additional data. The Company said it is actively continuing to develop data to support resumption of the EMERALD trial. The Company's clinical protocols in cardiovascular diseases, which come under the jurisdiction of CDER's Division of Cardio-Renal Drug Products, remain open, according to a company release.