Lomucin Trial Ends Due to Lack of Efficacy

July 9, 2007

Cystic Fibrosis Foundation Therapeutics, Inc. and Genaera Corporation have agreed to discontinue the Phase 2 clinical evaluation of Lomucin for CF because it was deemed unlikely that continued enrollment of patients into the study would ever result in the drug being proven effective.

The study was terminated based on a recommendation by Genaera to the study’s Data Monitoring Committee. The committee identified no safety concerns in their review of the data and agreed that the study should end.

About two-thirds of the drugs that make it past Phase 1 testing continue on to Phase 2 trials. Safety and effectiveness are examined in these trials. In most Phase 2 trials, one group of volunteers may be given the experimental drug while another “control” group will receive a placebo. A Phase 2 trial does not give a final assessment of whether or not a particular drug will successfully treat an illness, although many patients may report experiencing some therapeutic benefits.

Currently, there are nearly 30 potential therapies in the CF Foundation's drug development pipeline. It is estimated that only one in five new drugs that enter clinical trials will become an approved therapy for patients. This is why the Foundation must continuously feed the drug development pipeline to better the success for all people with CF.