Genaera Corporation and Cystic Fibrosis Foundation Therapeutics (CFFT) announced Phase II clinical trial results for the mucoregulator drug, Lomucin. The trial demonstrated a strong safety profile for the drug, and maintenance of existing lung function in people with cystic fibrosis (CF). It is hoped that the administration of Lomucin will lead to a reduction in the over production of mucus in the respiratory tracts of patients and therefore, lead to improved lung function.

The results are being presented by Professor Gerry McElvaney, department chair and chief of medicine at the Royal College of Surgeons, Ireland, based at Beaumont Hospital, Dublin. The Phase II clinical trial, supported by a grant from CFFT, the nonprofit drug discovery and development affiliate of the CF Foundation, was a randomized, double-blind study conducted in Ireland in 55 individuals with CF. Patients were treated with the study dose, 740 milligrams of Lomucin (talniflumate) three times daily for four weeks, or matching placebo. In the trial, 36 individuals were randomized to Lomucin and 19 to placebo.

"CFFT will work closely with Genaera to evaluate the Phase II trial results and to plan further clinical evaluation of Lomucin in CF. The potential therapeutic benefit of a mucoregulator approach in CF could be very significant for our patients and therefore deserves an intense and dedicated follow-up effort to determine next steps," said Robert J. Beall, president and CEO of the Cystic Fibrosis Foundation and CFFT. "As always, our focus remains on pursuing the most promising therapies to improve and extend the lives of those with CF."

"Lomucin was well tolerated by people with CF, and we believe that larger and longer term trials might be considered for demonstrating potentially beneficial effects on pulmonary function. We plan to complete our detailed evaluation of these results and to work with CFFT to determine the most appropriate path forward for Lomucin in CF," said Roy C. Levitt, Genaera's president and CEO. "We believe we have a strong intellectual property position developing for the target hCLCA1. We are also eager to explore all strategies for modulating hCLCA1 function, including antibody approaches, based on program specific funding for these opportunities."