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news.Medicinova, a biopharmaceutical company, has announced its plans to modify phase II placebo controlled clinical trial intended to evaluate mn-221 in patients with severe, acute exacerbations of asthma.
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The modification is based on the analysis of data from the recently completed Phase II clinical trial (MN-221-CL-006), which evaluated MN-221 at planned escalating doses in patients with severe, acute exacerbations of asthma and two earlier phase II clinical trials (MN-221-CL-004 and MN-221-CL-005), which evaluated MN-221 in patients with stable asthma.
In MN-221-CL-006 clinical trial, patients who received MN-221 at 240 micrograms over 15 minutes in combination with standard care demonstrated the best efficacy based on improvements in forced expiratory volume in 1 second (FEV1) and in hospitalization rate.
The company has submitted an amendment to the clinical trial protocol for MN-221-CL-007 to FDA, which reflects the modified dosing regimen, and plans to submit the same information to the relevant regulatory authorities outside the US.
MediciNova has communicated this modification to the participating study investigators and clinical sites and will wait to further enroll patients in this study, pending review and approval of the amended clinical trial protocol by the relevant regulatory authorities.
Yuichi Iwaki, President and CEO, MediciNova, said:these clinical results from our three completed phase II clinical trials support the potential efficacy of lower doses of MN-221 plus standard treatment in patients with acute exacerbations of asthma based on improvements in FEV1 and in rates of hospitalizations.”
We believe that testing a lower potentially effective dose will maximize the benefit of MN-221’s safety profile and offer a more convenient 15 minute dosing regimen,” he added.