JERSEY CITY, N.J., October 15, 2021 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that two abstracts on amyotrophic lateral sclerosis (ALS) will be presented during the 146th Annual Meeting of the American Neurological Association (ANA2021), being held virtually October 17-19.
“We are pleased to share the design for the first global Phase 3 study of investigational oral edaravone as an exciting step forward in evaluating the use of this formulation in patients with ALS,” said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. “Our commitment to the ALS community goes beyond investigating treatments and includes our determination to understand the real-world impact of this devastating disease on patients and caregivers. We hope the real-world findings presented at ANA2021 will provide insight on the significant impact that ALS may have on close family members, and in turn help inform the development of appropriate and necessary support services.”
MTPA posters will be available for viewing throughout the ANA2021 meeting. Key data to be presented include:
Oral Edaravone Development Program
An overview of the study design and baseline characteristics for the global Phase 3, open-label, multicenter study (MT-1186-A01) assessing the long-term safety and tolerability of an investigational oral suspension of edaravone will be presented. The study, which is sponsored by Mitsubishi Tanabe Pharma Development America, Inc. (MTDA), is evaluating 213 ALS patients across approximately 50 sites in the U.S., Canada, Europe and Japan over the course of 48 weeks of treatment.
- Phase 3, Open-Label, Multicenter Safety Study of Oral Edaravone Administered Over 48 Weeks in Subjects With Amyotrophic Lateral Sclerosis: Study Design and Baseline Characteristics (MT-1186-A01) (Poster #LB-449; Manabu Hirai, Mitsubishi Tanabe Pharma Corporation)
An analysis examining the humanistic and economic burden experienced by caregivers of patients with ALS will be presented based on data drawn from the Adelphi ALS Disease Specific Programme™, a point-in-time survey of neurologists and their consulting patients with ALS, between July 2020 and March 2021.
- Burden Among Caregivers of Patients with Amyotrophic Lateral Sclerosis in the United States (Poster #234; Melissa Hagan, Ph.D., M.P.H., MTPA)
MT-1186 is an investigational oral suspension 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. More information on the oral edaravone development program is available at ClinicalTrials.gov (NCT04165824 and NCT04577404).
About Mitsubishi Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation’s (MTPC) 100 percent owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. It was established by MTPC to commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on Twitter, Facebook and LinkedIn.
About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), founded in 1678, is one of the oldest pharmaceutical companies in the world. Focused on ethical pharmaceuticals, MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan’s pharmaceutical industry. In light of the anticipated changes in healthcare needs in the future, MTPC is advancing business activities under the mission of “Creating hope for all facing illness,” and has set the corporate vision for 2030 (VISION 30) to “Be a healthcare company that delivers optimal therapy to each individual.” As part of the vision for 2030, MTPC is prioritizing work on “precision medicine” to create effective therapies and preventive methods by identifying patient populations with high potential for efficacy and safety, focusing on the disease areas of central nervous system and immuno-inflammation. In addition, MTPC is working to develop “around the pill solutions” to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. MTPC is a member of Mitsubishi Chemical Holdings Group. For more information, go to https://www.mt-pharma.co.jp/e/.