MN-001, a small molecule inhibitor of inflammatory mechanisms known to be involved in asthma, was evaluated in a randomized, double-blind, placebo-controlled multi-center phase II clinical trial in patients with mild-to-moderate asthma. 147 patients were randomly assigned to receive placebo or MN-001 tablets in one of three oral dosing regimens for 4 weeks.
The primary endpoint of the trial was achieved with a statistically significant improvement after 4 weeks of treatment with 500 mg MN-001 compared to placebo.
MN-001 was well tolerated in this trial with 89% of patients completing the course of treatment. There was no apparent difference between placebo and any of the active treatment groups in adverse events leading to discontinuation or in adverse events attributable to treatment.
“The results of this trial suggest that MN-001 may be an effective oral treatment for asthma that could offer a new approach to treating a complex, multi-modal disease that affects up to 300 million people worldwide,” said Dr Richard Gammans, chief development officer of MediciNova.