MediciNova (NASDAQ: MNOV) provides a development update on its two lead programs, MN-221 and MN-166.
End-of-phase 2 guidance from the FDA and the newly extended patent protection (to expire no earlier than 2030) for use of MN-221 in the treatment of acute exacerbations of asthma (AEA) provide a clear development path for MN-221. Additional manufacturing and clinical development, which will be partner-dependent, will be undertaken prior to initiation of a pivotal trial program.
MediciNova will leverage its MN-166 neurological program with grant-aided Phase 2 studies to advance MN-166 towards regulatory approval, initially in drug dependence. A phase 2 trial in methamphetamine dependence is scheduled to start in first half 2013 and could lead to MN-166 becoming the first FDA-approved product for treatment of methamphetamine dependence.
“During the past several months MediciNova has been refining the development strategy for our lead product candidates,” Dr. Yuichi Iwaki, President and CEO of MediciNova commented. “With the guidance of the FDA, we are planning further MN-221 development towards our ultimate goal of obtaining regulatory approval of
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