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www.fdanews.com/articles/81077-genaera-initiates-phase-ii-clinical-trial-of-lomucin

GENAERA INITIATES PHASE II CLINICAL TRIAL OF LOMUCIN

September 21, 2005

Genaera has launched a pivotal Phase II clinical trial for the mucoregulator drug, Lomucin, in people with cystic fibrosis (CF). Cystic Fibrosis Foundation Therapeutics (CFFT), the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation, is supporting this trial, with study-specific funding of up to $2.35 million.

This study, which will be initiated in Ireland, will evaluate the use of Lomucin in 200 individuals with CF through a multicenter, randomized, double-blind, placebo-controlled trial. The study will assess the safety and efficacy of Lomucin oral tablets on pulmonary function and related symptoms. A previous exploratory Phase II study demonstrated a trend toward better lung function in people with CF who took Lomucin compared to those receiving placebo tablets and found that Lomucin was well-tolerated in the study.

This study will administer Lomucin oral tablets three times per day for 52 weeks to 100 individuals with CF. Placebo tablets will be administered to an additional 100 people with the disease.