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Disappointing phase 3 trial results of a drug approved for the treatment of amyotrophic lateral sclerosis (ALS) may prompt the manufacturer to voluntarily pull it from the market, the company announced today.
After 48 weeks, sodium phenylbutyrate-taurursodiol (Relyvrio) offered no significant improvements compared to placebo, failing to meet the randomized controlled trial’s primary or secondary endpoints, Amylyx Pharmaceuticals announced in a statement.
“We are surprised and deeply disappointed by the PHOENIX results following the positive data from the CENTAUR trial,” co-CEOs Justin Klee and Joshua Cohen said in the statement. “Over the next 8 weeks, our team will continue to engage with regulatory authorities and the ALS community to discuss the results from PHOENIX.”
As reported by Medscape Medical News, Amylyx Pharmaceuticals received approval for Relyvrio in September 2022 following an initial rejection by a US Food and Drug Administration expert panel that was later reversed in a rare second panel review.
The agency based its approval largely on results from the multicenter, phase 2, 24-week CENTAUR trial. In that study, treatment with Relyvrio was associated with a 25% slower decline in function and statistically significant median difference of 4.8 months in time to death, first hospitalization, or tracheostomy/permanent assisted ventilation compared with placebo.
Those findings, along with testimony submitted by more than 1300 ALS patients, advocates, and clinicians, were enough to sway the advisory panel to reverse its earlier decision.
At the time of the second hearing, the PHOENIX trial had enrolled about half of its target of 600 participants. Klee told committee members then that if the phase 3 trial didn’t meet its endpoints, “we will do what is right for patients, which includes voluntarily removing the product from the market.”
Topline results from PHOENIX released today showed no significant difference between the treatment or placebo in total score change in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale from baseline to week 48 (P=.667). There were also no significant differences observed across secondary endpoints and no new safety concerns.
The drug is also approved for ALS in Canada under the name Albrioza.
“Amylyx will continue to engage with regulatory authorities and the broader ALS community, including ALS specialists and other multidisciplinary experts, people living with ALS, and advocates, to discuss the results from PHOENIX within the next 8 weeks and make informed decisions,” the company’s statement said. “Amylyx intends to share plans for Relyvrio/Albrioza in ALS, which may include voluntarily withdrawing Relyvrio/Albrioza from the market. At this time, Relyvrio/Albrioza and its related patient support program will continue to be available for people living with ALS. Amylyx has voluntarily decided to pause promotion of the medication during this time.”
Clinical trials of the drug currently underway for the treatment of Wolfram syndrome and progressive supranuclear palsy will continue, the company said.
Kelli Whitlock Burton is a reporter for Medscape who covers neurology and psychiatry.
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