MTPA Announces Initiation of Open-Label Extension Study of Oral Edaravone in ALS

Mitsubishi Tanabe Pharma America (MTPA) announced the initiation of a long-term safety extension study (MT-1186-A03) to the ongoing Phase 3 trial evaluating an investigational oral formulation of edaravone in patients with amyotrophic lateral sclerosis (ALS). The studies are sponsored by Mitsubishi Tanabe Pharma Development America, Inc. (MTDA).

"As a company, we strive to always put patients first in our efforts to understand this debilitating disease," said Atsushi Fujimoto, President, MTPA. "We hope this extension study will help provide important information to the ALS community."

The global, open-label, multi-center extension study will continue the evaluation of safety and tolerability of the investigational oral formulation of edaravone in patients who have completed 48 weeks of treatment in the initial Phase 3 study (MT-1186-A01). Extension study participants will continue to receive oral edaravone for up to 96-weeks, at a dose that is bioequivalent to the IV formulation of RADICAVA® (edaravone) approved by the U.S. Food and Drug Administration in 2017.

The primary outcome measures include safety and tolerability as measured by incidence of adverse events (AEs), adverse drug reactions (ADRs), and treatment-emergent adverse events (TEAEs) from baseline to Week 96. Other outcome measures include a change from baseline to Week 96 in the ALS Functional Rating Scale-Revised (ALSFRS-R), time (days) to death, tracheostomy, or permanent assisted mechanical ventilation (≥ 23 hours/day).

MT-1186 is an investigational oral formulation of edaravone being studied in patients with amyotrophic lateral sclerosis (ALS). Edaravone was discovered and developed by researchers together with Mitsubishi Tanabe Pharma Corporation (MTPC), headquartered in Osaka, Japan. In May 2019, MTP group companies completed a series of Phase 1 studies administering the oral suspension and intravenous formulations of edaravone in healthy volunteers.