Phase 3 Trial of Ibudilast Planned for SPMS Patients with Inactive Disease, MediciNova Says

Source Medical News Toady: A Phase 3 trial is planned to confirm the safety and efficacy of oral ibudilast (MN-166) in treating people with secondary progressive multiple sclerosis (SPMS) without relapses or those whose disease is not active, MediciNova announced.

Data from this single Phase 3 study may be used to request marketing approval for ibudilast with the U.S. Food and Drug Administration (FDA), the company said in a press release.

Ibudilast, a first-in-class small molecule, works to suppress three cytokines (small signalling proteins) that promote inflammation: IL-1ß, TNF-a, and IL-6. It may also increase the activity of the anti-inflammatory cytokine IL-10, and help block the signals of toll-like receptor 4 (TLR4) that is involved in inflammation. All these activities are thought to contribute to ibudilast’s ability to ease neuroinflammation.  Read on.