Acebilustat, a once-daily oral drug candidate, is currently being evaluated for the treatment of inflammatory diseases. The drug is a new small molecule inhibitor of Leukotriene A4 Hydrolase (LTA4H), the key enzyme in the production of the potent inflammatory mediator Leukotriene B4 (LTB4).
Designed in consultation with Cystic Fibrosis Foundation Therapeutics (CFFT), the trial will evaluate the lung function preservation effects of once-daily oral acebilustat treatment over 48 weeks.
Earlier this year, the CFFT awarded a $5m research grant to Celtaxsys to partially fund the trial.
Celtaxsys chief medical officer Sanjeev Ahuja said: "The interplay between infection and inflammation is the main driver for lung function decline in CF.
"Finding a proper balance in immune modulation is key to treating the inflammation and resultant decline in lung function without increasing risk of infection.
"In a previous clinical trial in CF patients, acebilustat reduced important biomarkers of lung and systemic inflammation without apparent increased susceptibility to infection."
Celtaxsys CEO Greg Duncan said: "Once-daily oral acebilustat treatment can potentially address the underlying inflammation that results in irreversible lung function decline and occurs in all CF patients, independent of CFTR genotype."
The Phase II CF trial of acebilustat is scheduled to be initiated in the US by October this year. The company noted that regulatory submissions to the health authorities in Europe will be filed soon after.