Australian biotech CSL Limited (OTCQX:CSLLY) fell ~4% on Monday, marking its biggest intraday loss in more than four months after its Phase 3 AEGIS-II trial, one of its key clinical programs, failed.
The overall trial was designed to evaluate serum CSL112 protein versus placebo to reduce the risk of major adverse cardiovascular events, such as stroke, in patients after a heart attack (acute myocardial infarction).
AEGIS-II did not meet the primary efficacy goal of MACE reduction at 90 days, CSL Limited (OTCQX:CMXHF) said, adding that there were no safety or tolerability issues. In the wake of the setback, the company has no plans to make regulatory filings in the near term.
“AEGIS-II is the most ambitious study in our company's history, and we are proud of the quality of the study we conducted and the enhanced capabilities we developed to do it,” said Bill Mezzanotte, director of R&D at CSL (OTCQX :CSLLY). .