Yesterday, MediciNova, Inc. announced that the U.S. Food and Drug Administration (FDA) relayed positive feedback regarding its phase III clinical trial plan to test MN-166 (ibudilast) in a broad population of people with ALS. No safety issues were raised by the FDA and safety will be revisited when results are available in the phase III trial.
The ALS Association helped support the phase II trial through funding the PBR28 PET (positron emission tomography) imaging biomarker study that was conducted by Dr. Nazem Atassi at Massachusetts General Hospital in parallel to the trial. PBR28 is a biomarker that measures inflammation in the brain, which can track inflammation over time and evaluate the effects of ibudilast on brain inflammation.
MN-166 is an oral pill aimed at reducing inflammation in the brain and spinal cord. There is evidence that neuroinflammation accompanies motor neuron death in ALS. Over 20 years ago, ibudilast was approved in Japan to treat post-stroke complications and asthma.
Leadership at MediciNova plan to move the phase III trial forward based on the FDA’s feedback.
Read more about this announcement and the FDA’s feedback here.