MediciNova believes the appropriate clinical development for MN-221 will involve conducting dose regimen and AEA trial design optimization studies prior to commencing pivotal trials. Currently, MediciNova is working with licensor and API supplier, Kissei Pharmaceutical Co., Ltd. to address the manufacturing requirements before further clinical development is commenced. MediciNova has determined that any additional future MN-221 clinical trial development will be partner-dependent from a funding perspective.
"We believe the recently-allowed patent for MN-221 for use in the treatment of AEA can significantly increase the length of marketing exclusivity and hence the potential value of MN-221," said Dr. Kazuko Matsuda, patent inventor and Chief Medical Officer of MediciNova. "We look forward to keeping our shareholders updated on our MN-221 progress."
MN-166 Development Plan
The company has been very successful in facilitating investigator-led, development funding to advance the diverse MN-166 (ibudilast) program. The recent grants from the National Institute on Drug Abuse (NIDA) have accelerated the development of MN-166 in drug dependence. Currently ongoing are a Phase 2a clinical trial in opioid dependence led by investigators at Columbia University and the New York State Psychiatric Institute and a Phase 1b clinical trial in methamphetamine dependence that will lead to an already-funded Phase 2 trial in methamphetamine dependence, led by investigators at UCLA. The Phase 2 trial is expected to begin in the first half of 2013. These clinical trials are conducted by some of the country's leading experts in opioid and methamphetamine addiction. MediciNova's method-of-use patent for MN-166 in drug addiction expires no earlier than 2030 in the US."We are excited about the positive developments of the MN-166 program and the continuing grant support. Going forward, MediciNova will focus our resources on accelerating and optimizing MN-166 development in collaboration with the investigators conducting multiple grant-funded, proof-of-concept clinical trials," said Dr. Iwaki. "In addition to the potential to address a large unmet medical need in opioid dependence, MN-166 also has the potential to become the first approved product for the treatment of methamphetamine dependence."