The combination of pirfenidone and nintedanib can offer patients significant efficacy advantages over either product alone. A combination of oral medications has not been feasible due to their additive side effect profiles. AP03 is a fixed-dose combination that we intend to develop for inhaled delivery.
Our data indicate that as stand-alone therapies, Avalyn’s product candidates may substantially reduce or eliminate the adverse effects of oral pirfenidone and oral nintedanib. Further, direct drug delivery to the lungs may increase their efficacy by delivering an optimized dose. Moreover, as safe and well-tolerated medicines, inhalation may improve compliance and enable use in otherwise poorly tolerated add-on combination regimens.