SAN DIEGO, Jan. 3, 2013 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on the NASDAQ Global Market (Nasdaq:MNOV) and the Jasdaq Market of the Osaka Securities Exchange (Code Number: 4875), 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 MN-221 for the treatment of AEA. With MN-166, we are very encouraged to now have grant funding supporting Phase 2 clinical trials in drug dependence scheduled to provide significant data readouts over the next two years."
MN-221 Development PlanMediciNova plans to conduct the MN-221 program according to the feedback from FDA following the end-of-phase 2 meeting in October 2012. The FDA identified the risk/benefit profile of MN-221 as a focal point for further development and advised that a clinical outcome, such as a reduction in hospitalizations, would need to be a pivotal trial primary endpoint. Previously completed Phase 2 studies have evaluated the potential for MN-221 to reduce hospitalizations due to AEA.