MediciNova gearing up for FDA meeting
Calling results of its Phase 2b clinical trial with MN-221 encouraging, MediciNova (NASDAQ:MNOV; OSE:4875) figures it has the efficacy and safety data, and trial design “necessary for a productive discussion” with the FDA at a planned end-of-Phase 2 meeting.
The FDA’s Division of Pulmonary, Allergy, and Rheumatology Products has reviewed MediciNova’s meeting request submission and granted an end-of-Phase 2 meeting for Oct. 22.
“If all goes well, we anticipate moving our program into pivotal development in the first half of 2013,” CEO Dr. Yuichi Iwaki said in the second quarter report. MN-221 is being developed for the treatment of acute exacerbations of asthma.
In addition, Dr. Iwaki said the company is committed to exploring opportunities to allow for the continued clinical development of ibudilast in a proof-of-concept Phase 2 trial in drug addiction and/or progressive multiple sclerosis.
MediciNova management plans to host a corporate update conference call later in the quarter to focus on the clinical development of MN-221 and MN-166 and the strategy moving forward.