Additional data on Radicava (edaravone) and the clinical trial that led to its approval to treat amyotrophic lateral sclerosis (ALS) will be presented in oral and poster presentations at the 28th International Symposium on ALS/MND that opens in Boston on Friday.
Mitsubishi Tanabe Pharma America announced that its one oral presentation, highlighting the importance of patient selection in clinical trials and good trial design in improving a study’s outcomes and speed, will take place on Friday, Dec. 8.
The presentation is titled “Towards More Efficient Clinical Trial Designs in ALS: Lessons from the Edaravone Development Program.”
“In a pooled, post-hoc exploration of individuals who met the inclusion criteria for MCI186-19 [Phase 3 trial] in the overall edaravone development program, advantages versus placebo may be evident as early as the first cycle (28 days) of therapy,” Joseph Palumbo, MD, the company’s vice president who will give the presentation, said in a press release. “We also hope to clearly show the results seen among … individuals with steady linear progression in the edaravone development program are generalizable to the larger population of those diagnosed with ALS.”
Radicava’s pivotal Phase 3 clinical study (NCT01492686), conducted in Japan, assessed the effectiveness of the treatment at six months, using the ALS Functioning Rating Scale Revised (ALSFRS-R), a tool to measure the patients’ ability to perform daily activities.
To better evaluate changes in functional abilities — those clinically and statistically meaningful — with the trial’s 24-week treatment period, researchers wrote inclusion criteria that favored enrollment of patients with higher functional abilities but relatively rapid progression rates. “If patients with limited function had been entered into the trial, it would have been difficult to evaluate change in function,” MT Pharma America states in the release.
An open discussion will follow, the presentation attendees the opportunity to discuss these points and other Phase 3 trial results.
The company will also present three posters — “Edaravone in ALS: An Assessment of Safety, Tolerability, and Treatment Persistence,” “Onset of Detectable Effect of Edaravone: a Post Hoc Analysis,” and “Edaravone in ALS: the effect of potential drug-drug interactions via p450” on Saturday.
Radicava, given as anan intravenous infusion in 14-day treatment cycles, was approved by the U.S. Food and Drug Administration (FDA) on May 5, 2017, to treat ALS patients.