Map reports positive results of Phase IIa asthma trial

This randomized, open-label, active-controlled, crossover, safety and dose response study investigated the pharmacokinetics (PK) and pharmacodynamics of MAP0005 in 15 adult asthmatics. The trial assessed the ability of MAP0005 to deliver budesonide to the lungs, as measured by PK, and formoterol to conducting airways in amounts sufficient to provide bronchodilation, both compared to the leading currently approved budesonide/formoterol combination product. The study also examined the consistency and efficiency of the Tempo inhaler in asthmatic patients.

The trial compared two different emitted doses of MAP0005, 104/5.4mcg and 312/16.2mcg of budesonide/formoterol with the 160/9mcg dose of the commercially marketed combination product. Maximum change in forced expiratory volume in one second (FEV1) was similar for all three treatments, as was time to maximum change in FEV1. Plasma levels of budesonide were dose proportional for MAP0005. No serious or unexpected adverse events were reported in the study, and MAP0005 was well tolerated.

MAP0005 is a single-particle combination of budesonide, a corticosteroid, and formoterol, a long-acting beta2-agonist, delivered to the respiratory tract using the company’s Tempo inhaler.

Timothy Nelson, president and CEO of Map Pharmaceuticals, said: “The results of our Phase IIa trial with MAP0005 demonstrate our ability to apply our proprietary technologies to combine two drugs within a single particle in a pre-specified ratio and deliver them to the lung.”