Altair Therapeutics reports successful Phase I study of inhaled AIR645
Altair Therapeutics, Inc. announced positive results from a phase I multiple dose safety and pharmacokinetic study of its lead product, once-weekly inhaled AIR645 in healthy adults and mild asthmatics. The results were presented by Dr. Michael Hodges, M.D., Chief Medical Officer for Altair Therapeutics at the European Respiratory Society Annual Congress in Vienna.
AIR645 is a non-steroidal dual inhibitor of cellular responses to interleukin (IL)-4 and IL-13. These pro-inflammatory cytokines orchestrate the adaptive immune response to inhaled allergens and viruses and the development of chronic inflammation in asthma, rhinitis and other respiratory disorders. The randomized, placebo-controlled trial evaluated the safety, tolerability, bioavailability and pharmacodynamic activity of nebulized AIR645 at multiple dose levels in 32 healthy adult subjects (0.3, 3, 10, and 20 mg/dose) and eight mild asthma subjects (20mg/dose). Subjects were sequentially randomized (six active: two placebo) and received six doses on study days 1, 3, 5, 8, 15 and 22.
AIR645 was safe and well tolerated. No dose-limiting toxicities or safety signals were detected in this clinical study. Adverse effects were mostly mild and none were considered severe, significant, or serious and no subjects were discontinued due to adverse events.
AIR645 exposure in sputum was found to be dose-dependent, and no accumulation of drug was evident. AIR645 half-life in sputum was calculated to be approximately 5 days. AIR645 concentration was >1000-fold higher in sputum than in plasma, indicating very low systemic bioavailability of the drug.
Following repeated inhalation of AIR645 evidence of anti-inflammatory biomarker activity was seen in subjects with mild asthma (those that had baseline elevations of biomarkers), including reductions in serum total IgE, sputum eosinophils or level of 15-HETE in sputum.
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