Local biopharmaceutical company MediciNova Inc. received enough positive news from a phase 2b clinical trial evaluating its MN-221 asthma compound to pursue planning for phase 3 trials.
In announcing preliminary results from a hospital emergency department-based clinical trial May 23, MediciNova reported that its MN-221 used to treat patients with acute exacerbations of asthma did not statistically meet the primary endpoint compared to a placebo.
“Unfortunately it was not able to meet its primary endpoint, however, we were able to see significant improvement (in patients) at one hours and two hours,” said Dr. Yuichi Iwaki, president and CEO of MediciNova. “It makes sense from a pharmacological analysis.”
Iwaki added that no safety or tolerability issues of clinical significance were observed during the trial, which was conducted with 175 patients at 24 hospitals including UC San Diego and UCLA. Iwaki said only three patients had an adverse reaction caused by bronchitis or other condition not related to the drug.
In another positive sign, the hospitalization rate among patients taking MN-221 was reduced by 17 percent, which Iwaki described as “substantial.”
Having filed an end-of-phase 2 meeting request with the division of Pulmonary, Allergy and Rheumatology Products at the Food and Drug Administration, Iwaki said he’s confident the FDA will accept the improved responses at one hour and two hours and allow the company to enter phase 3 trials sometime this year.