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AMX0035 reduces the risk of death in ALS patients by almost half

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October 16, 2020

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Disclosure:
Paganoni received grants from the ALS Association, ALS Finding a Cure Initiative, and Amylyx Pharmaceuticals during the course of the study, and received grants from Biohaven, Clene Nanomedicine, Prilenia, Ra Pharma, and Revalesio Corporation in addition to the work submitted. I am reporting. See the survey for relevant financial disclosures of all other authors.

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AMX0035, a neuroprotective therapy in clinical trials, reduced the risk of death in patients with amyotrophic lateral sclerosis by almost half, according to the results of the CENTAUR trial overall survival analysis.

The life-prolonging effect of AMX0035 occurred either alone or in combination, regardless of baseline use of riluzole or edaravone.

Sabrina Paganoni

“There are many reasons to be encouraged today.” Sabrina Paganoni, MD, PhD, Principal investigators for the CENTAUR trial, Sean M. Healy & AMG Center for ALS researchers at Massachusetts General Hospital, and assistant professors at Harvard Medical School and Spalding Rehabilitation Hospital said in a press release. “This trial showed promising functional and survival benefits …. I am very excited about the potential of this drug for people living with ALS.”

A 24-week randomized, double-blind, placebo-controlled, phase 2/3 CENTAUR study examined the safety and tolerability of AMX0035 and its efficacy. Disease progression According to ALS Function Evaluation Scale-Revised. The study also analyzed the effects of drugs on other ALS disease markers, such as muscle strength, vital capacity, and biomarkers of neurodegeneration.

The survival analysis compared the time to death (mortality from all causes) between the participants first assigned to treatment with AMX0035 and the participants first assigned to the placebo group. The longest follow-up period was 35 months.

Researchers observed a 44% reduction in mortality risk during follow-up of patients initially assigned to AMX0035 compared to patients originally assigned to placebo (HR = 0.56; 95%). CI, 0.34-0.92). Patients initially assigned to aggressive treatment with AMX0035 were 25 months compared to patients initially assigned to placebo who survived a median of 18.5 months (95% CI, 13.5-23.2 months). Survived the median (95% CI, 19-33.6 months). .. According to the results of a study on AMX0035 published in, this represents a 6.5-month difference in survival. muscle & Nervous..

According to the results published in, the aggressive treatment group and the placebo group experienced similar proportions of death-equivalent events. muscle & Nervous.. Six participants (6.7%) originally assigned to AMX0035 and four participants (8.3%) originally assigned to placebo experienced these types of events.

Previous results from the CENTAUR study Was announced in The· New England Journal of Medicine AMX0035 has also been demonstrated to reduce the rate of functional decline compared to placebo in ALS patients.

These results support the “functional and long-term survival benefits” of AMX0035. Worth Cudkowicz, MD, Sean M. Healy & AMG Center for ALS Director, Massachusetts General Hospital Neurology Director, ALS Finding a Cure Chief Medical Officer, and Julian Dawn Neurology Professor, Harvard Medical School, said in a press release. “These results show that AMX0035 may provide patients with hope, better functioning and the opportunity to live longer.”

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