The other three patents cover potential therapies for additional inflammatory diseases.
Acebilustat is designed to reduce an overabundance of white blood cells known as neutrophils in CF patients’ lungs. The high levels are associated with inflammation.
The therapy inhibits leukotriene A4 hydrolase, the principal enzyme involved in the production of leukotriene B4, a potent inflammation regulator. CF patients have elevated levels of leukotriene B4.
By reducing neutrophils, acebilustat decreases lung inflammation and dysfunction, without any immunosuppressive effect.
Celtasys is conducting a Phase 2 clinical trial (NCT02443688) of acebilustat’s ability to reduce lung inflammation and preserve lung function over 48 weeks. The ongoing trial is also assessing the once-a-day oral dose’s safety, and patients’ ability to tolerate it.
Researchers are randomly assigning 200 patients to receive either 50 mg or 100 mg of acebilustat or a placebo, in addition to CF standard of care. The standard therapies include the CFTR regulators Orkambi or Kalydeco, both developed by Vertex.
The trial results are expected to be released in mid-2018.
Celtaxsys recently obtained financing for a Phase 3 trial of acebilustat in CF.
“The expansion of our intellectual property platform represents important and continued progress for Celtaxsys, as well as for the 75,000 CF patients who are counting on companies like Celtaxsys to develop a safe and effective treatment for lung inflammation, which is still the leading cause of morbidity and mortality in CF,” Greg Duncan, Celtaxsys’s chief executive officer, said in a press release.
Celtaxsys has obtained other patents for its products before this new round of approvals.
Its three new non-acebilustat patents cover Celtaxsys’ second-generation LTA4H inhibitors, which have the potential to become treatments for other inflammatory diseases. The patents apply to skin-applied, inhaled, and injected formulations of the inhibitors.
“The field of LTA4H inhibitors is a largely untapped arena for treatment of human diseases,” said Andrew Luster, a Harvard Medical School professor who is also chief of Rheumatology, Allergy & Immunology at Massachusetts General Hospital. “Emerging science in the field of LTA4H and LTB4 points to potential applications across many serious inflammatory diseases, including CF, bronchiectasis, bullous dermatoses, NASH [nonalcoholic steatohepatitis] and cancer.”
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