CENTAUR

Treatment with AMX0035 significantly prolonged the time that people with amyotrophic lateral sclerosis (ALS) in the CENTAUR clinical trial did not require permanent ventilation or tracheostomy by over seven months, a new study shows. “People living with ALS often require medical interventions like mechanical ventilation as the disease…

A U.S. Food and Drug Administration (FDA) advisory committee has scheduled a virtual meeting with Amylyx Pharmaceuticals to review its application for the approval of AMX0035 to treat amyotrophic lateral sclerosis (ALS), the company announced. The online meeting to discuss data supporting the approval request is set for March 30.

The Canadian Neuromuscular Disease Registry (CNDR) and Amylyx Pharmaceuticals are collaborating on an initiative that could produce the first real-world evidence on AMX0035, Amylyx’s investigational therapy to slow functional decline in amyotrophic lateral sclerosis (ALS) patients. The two, in partnership with neuromuscular centers across Canada, will collect…

Amylyx Pharmaceuticals‘ global Phase 3 clinical trial investigating AMX0035 as an oral treatment for amyotrophic lateral sclerosis (ALS) has begun dosing participants. The PHOENIX trial (NCT05021536) is expected to include 600 participants whose symptoms began in the past two years, which is a less-stringent criteria than was required for…

A global Phase 3 trial of AMX0035 as an oral treatment for amyotrophic lateral sclerosis (ALS)  intends to enroll up to 600 patients, the therapy’s developer, Amylyx Pharmaceuticals, announced in a press release. Likely to begin in the coming months, the trial — to be called PHOENIX…

The final amyotrophic lateral sclerosis (ALS) patient treated with oral AMX0035 in the CENTAUR study has completed all scheduled follow-up visits and researchers will now evaluate data collected on the potential treatment’s safety and efficacy, Amylyx Pharmaceuticals, its developer, announced. Final results of the Phase 2 study (NCT03127514), which…

Amylyx has completed patient recruitment for the Phase 2 clinical trial CENTAUR, which addresses the safety and effectiveness of AMX0035 as an oral treatment for amyotrophic lateral sclerosis (ALS). In 2017, Amylyx launched…

Amylyx Pharmaceuticals has dosed the first patient in a Phase 2 clinical trial that will assess AMX0035’s ability to treat amyotrophic lateral sclerosis. Researchers are seeking 132 participants for the CENTAUR study (NCT03127514). A unique feature of the trial is that Amylyx designed it in collaboration with patients and caregivers…