WebNov 4, 2024 · The primary efficacy outcome of the 48-week, randomized placebo-controlled PHOENIX Phase 3 trial will be a joint assessment of Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total score progression over … WebMar 30, 2024 · "The PHOENIX trial builds on the success of the CENTAUR trial, which was designed and conducted at US sites of Northeast ALS Consortium (NEALS), a network of 140 trial-ready research centers primarily based in North America,” principal investigator of the CENTAUR study, Sabrina Paganoni, MD, PhD, investigator, Healey & AMG Center for …
Global Phase 3 Trial of AMX0035 to Enroll 600 ALS Patients, …
WebFeb 2, 2024 · Amylyx anticipates topline results in 2024. The study enrolled 664 participants living with ALS. “The Phase 3 PHOENIX trial was an excellent collaboration between … WebThis clinical trial is designed to demonstrate that treatment is safe, tolerable, and able to slow decline in function as measured by the ALSFRS-R and survival over 48 week. The … high km affinity
FDA Panel Votes Against AMX0035 for ALS, Citing Doubt in Its …
WebSep 8, 2024 · The PHOENIX trial will enroll up to 600 ALS patients at 55 sites across the U.S. and Europe. AMX0035 is made of two small molecules, tauroursodeoxycholic acid and sodium phenylbutyrate, that protect nerve cells. Both compounds are in clinical use, and known to be generally safe and well-tolerated. WebApr 14, 2024 · The exploratory open-label proof of biology trial will evaluate the safety and tolerability along with various measures of endocrinological, neurological and ophthalmologic function of AMX0035. ... Amylyx announced the completion of subject enrolment in the Phase III PHOENIX trial of AMX0035 in amyotrophic lateral sclerosis … WebJan 4, 2024 · Dosing has begun in the PHOENIX trial, which is expected to include up to 600 participants whose symptoms started in the past two years — a less-stringent criteria than required for the CENTAUR trial. Participants will be assigned randomly to take a placebo or AMX0035 for 48 weeks (about 11 months). how is asthma investigated