Avant's TP10 fails to meet primary endpoint in phase 2b study of cardiac surgery

By Lisa Kerner

Erie, Pa., Feb. 27 - Avant Immunotherapeutics, Inc. said its lead complement inhibitor, TP10, did not meet the primary endpoint in a double-blind, placebo-controlled phase 2b study in female subjects undergoing high-risk cardiac surgery using cardiopulmonary bypass, confirming results for female subjects in a previous TP10 trial.

The primary efficacy endpoint of the study was the comparison of TP10-treated patients versus a placebo in the composite incidence of death and myocardial infarction, or heart attack.

The objective of the female-only study was to assess the safety and ability of TP10 to reduce the incidence of death and heart attack that occurs after cardiac surgery in female patients on cardiopulmonary bypass, according to a company news release.

A total of 309 female patients were screened with 297 patients randomized into the study to receive a 5 mg/kg dose of TP10, or a placebo, as a 30-minute intravenous infusion. The patients were followed for 28 days post surgery.

Avant said TP10 was well tolerated with no apparent differences in the safety profiles of the treatment groups.

A previous phase 2 study with TP10 in patients on cardiopulmonary bypass had demonstrated statistically significant efficacy in males but not in females, the company said.

"These data confirm the results in females from our previous TP10 trial," president and chief executive officer Una S. Ryan said in the release. "Therefore, given the strong efficacy data in males shown in this previous study, there is a clear clinical development pathway for a males-only indication for TP10 in cardiac bypass surgery."

Avant said males represent 75% of the U.S. market opportunity in cardiac bypass surgery.

Avant, based in Needham, Mass., discovers and develops vaccines and therapeutics that harness the human immune system to prevent and treat disease.

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