Genaera stops Ph II Lomucin trial

Pennsylvania, USA-based drugmaker Genaera Corp and development partner Cystic Fibrosis Foundation Therapeutics have agreed to discontinue a Phase II study of the anti-inflammatory agent Lomucin (talniflumate) in the treatment of cystic fibrosis. The data monitoring committee overseeing the trial advised, after conducting a planned interim review, that the program be closed on grounds of "futility."

Michael Gast, executive vice president of R&D at Genaera, explained, "Genaera and the Data Monitoring Committee planned a joint evaluation of the midpoint data from the Lomucin study to determine if the enrollment of final subjects...would allow a better understanding of the drug on respiratory function." He added that the committee found that there was no additional benefit to further enrollment, leading to closure of the program.

The joint termination decision triggers a final $100,000 payment from CFFT to Genaera, which is not required to refund any part of previous contributions that the CFFT has made. In addition, Genaera will, as a result of the agreement, recognize revenue of $2.1 million, of which some $2.0 million was previously recorded as a long-term liability.