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Person living with ALS in a motorized chair and their caregiver smiling

Building on early successes

PHOENIX (NCT05021536) is a Phase 3, randomized, placebo-controlled trial in more than 70 sites across the U.S. and Europe evaluating the safety and efficacy for AMX0035 (sodium phenylbutyrate/taurursodiol) in people living with amyotrophic lateral sclerosis (ALS). Recruiting for this trial is ongoing.

The primary objectives of the trial will be to further assess the safety and efficacy of AMX0035 as well as the impact of AMX0035 compared to placebo on disease progression over 48 weeks based on change from baseline of ALSFRS-R and survival. Additional measures that are critical to people with ALS, including change in slow vital capacity (SVC), serial assessments of patient reported outcomes, ventilation-free survival rates, and other outcomes, will also be assessed in PHOENIX.

Enrolling approximately 600 participants with definite or clinically probable ALS within 24 months of symptom onset, and with broader inclusion criteria than CENTAUR (NCT03127514), PHOENIX will be the first trial to include a global partnership between the Treatment Research Initiative to Cure ALS (TRICALS) and Northeast ALS (NEALS) consortium. Participants who complete the 48-week trial will have the option to receive AMX0035 after the trial if permitted by each regions’ regulatory guidance. This post-trial access to AMX0035 will also be dependent on regulatory and reimbursement milestones.

Looking ahead

Recruiting for the PHOENIX trial is ongoing. Learn more about the trial and enrollment information on ClinicalTrials.gov.

AMX0035

Zoomed in microscopic view of motor neuron

AMX0035

We are currently exploring the potential of our investigational therapy, AMX0035 (sodium phenylbutyrate/taurursodiol), for the treatment of ALS, Alzheimer’s disease, and Wolfram syndrome. Our aim is to expand upon this innovation to address other neurodegenerative diseases.

Our commitment

At Amylyx, we are relentlessly driven by a commitment to those living with neurodegenerative diseases. We dedicate every passing minute to developing potential therapies that will give them more quality time with friends, family, and loved ones.

Clinical trials

Our innovative approach to developing transformative therapeutics has far-reaching potential to improve the management of multiple neurodegenerative diseases. Learn more about our clinical trials.

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