MediciNova and the Hercules Market of the Osaka Securities Exchange have reported the proposed final protocol for phase II clinical trial (MN-221-CL-007). The trial will evaluate the safety and efficacy of MN-221 in patients with acute exacerbations of asthma.
Following a more comprehensive pharmacokinetic/pharmacodynamic analysis and model of data from previous phase II clinical trials, the study determined that the dose of 1,200mg of MN-221 may provide greater potential efficacy without conferring additional risk to patients.
MediciNova has submitted an amendment to the clinical trial protocol for MN-221-CL-007 to the FDA which reflects new dosing regimen, and plans to submit the same information to the relevant regulatory authorities outside of the US.
Yuichi Iwaki, President and CEO of MediciNova, said: After completing the more comprehensive PK/PD analysis, we concluded that the dose of 1,200 micrograms of MN-221 given over one hour had the best chance of proving the effectiveness of this promising new potential product for acute exacerbations of asthma. Most importantly, by going to this dose, we do not believe we are conferring additional risks to patients. Our safety analysis also included, in a blinded fashion, the safety data from the limited number of patients who already completed dosing in MN-221-CL-007 at the proposed dosing regimen.
We look forward to resuming the study and anticipate that patient enrollment will accelerate as we approach the peak asthma season in North America, he added.