Actelion falls on Veletri failure

Actelion (SWX:ATLN) was down CHF37.50 (25%) to CHF115.50 on Monday after announcing that it halted its Phase III VERITAS 1 and 2 trials of Veletri tezosentan to treat acute heart failure (AHF). ATLN stopped the trials and said it would end development of Veletri for AHF after an independent data safety and monitoring board (DSMB) told the company that a second interim analysis of VERITAS indicated that the trial would not meet either primary endpoint. The co-primary endpoints in the double-blind international trial in about 1,400 patients were improvement in dyspnea and morbidity/mortality. Patients in the trial received the standard of care plus Veletri or placebo. In June, with about 900 patients enrolled, the DSMB recommended that ATLN continue the trial (see BioCentury Extra, Monday June 7, 2004).

In 2001, the compound failed to improve dyspnea in the Phase III RITZ-1 study in AHF. Following RITZ-1, ATLN found that dose-related side effects in RITZ-1, such as hypotension, nausea and vomiting, might have masked clinical improvement on the RITZ-1 dyspnea endpoint. As a result, the company decided to undertake VERITAS. Veletri is an intravenous mixed antagonist of endothelin A and B receptors. Genentech (DNA) held U.S. co-promotion rights for Veletri. ...