Duvelisib: Phase IIa data
Top-line data from a double-blind, crossover, German and U.K. Phase IIa trial in 50 patients with mild, allergic asthma undergoing an allergen challenge showed that all 3 doses of oral duvelisib -- twice-daily 1 mg for 14 days, twice-daily 5 mg for 14 days and twice daily 25 mg for 5 days -- missed the primary endpoint of improving maximum early- or late-phase FEV1 response vs. placebo (p=0.052 for the late-phase FEV1 response for the 25 mg dose of duvelisib vs. placebo). On secondary endpoints, 25 mg duvelisib significantly improved FEV1 AUC over the entire assessment period (p=0.013) and significantly reduced patients' sensitivity to methacholine treatment (p=0.036) vs. placebo. The 5 and 25 mg doses of duvelisib also significantly reduced markers of airway inflammation vs. placebo. Infinity will present final data from the trial after all analyses are complete. The company said the data support further development of duvelisib in more severe forms of asthma. Infinity will determine next steps for duvelisib in inflammation after evaluating data from the Phase II ASPIRA trial of duvelisib to treat rheumatoid arthritis (RA), which are expected by year end. ...