CHAPEL HILL, N.C. … MoliChem Medicines (OTC: MLCM) has completed a Phase IB safety study of its lead product candidate, Moli1901, in 16 cystic fibrosis patients.
CF is characterized by the chronic formation of mucus plugs in a patient’s airways, caused by abnormal chloride and water transport. Moli1901 may normalize the mucus composition in the lung by activating an alternative chloride channel that is present in the surface cells of CF patients’ airways.
An initial study in CF patients found Moli1901 to be safe and well tolerated in nasal passages exposed to the drug. The latest study, conducted at Children’s Hospital Boston, Children’s Hospital Columbus and John Hopkins Children’s Hospital, further supports the safety of Moli1901 administered by aerosol inhalation in CF patients. No significant airway irritation nor serious adverse events were reported in the study.
“These data will support additional studies to characterize the residence time of the drug in the lung and the duration of action of Moli1901 in the CF lung,” MoliChem President and Chief Executive Luis Molina says in a statement. “The successful completion of this clinical trial in CF patients is an important milestone as we progress to Phase II studies.”