Patricia Inácio, PhD,  science writer—

Amyotrophic lateral sclerosis (ALS) patients who completed the expanded access protocol (EAP) for NurOwn may soon be eligible for three additional doses of the cell-based therapy, BrainStorm Cell Therapeutics reported. EAPs, also known as compassionate use programs, are intended to make investigational therapies available outside of a clinical trial…

Amydis announced plans to launch a first clinical trial next year into the ability of its small molecule tracer to detect toxic TDP-43 clumps — a hallmark of amyotrophic lateral sclerosis (ALS) — in the eye’s retina. Its announcement follows a preliminary meeting with U.S. Food and Drug Administration…

A Phase 2 trial of ZZ Biotech’s investigational therapy 3K3A-APC in people with amyotrophic lateral sclerosis (ALS) has started dosing patients at its single site in Australia, the company announced in a press release. The open-label trial (NCT05039268), underway at the Macquarie University in Sydney, aims to evaluate…

CNM-Au8, an investigational disease-modifying therapy for people with early amyotrophic lateral sclerosis (ALS), showed consistent clinical benefits in patients with both limb and bulbar onset disease, according to new analyses of RESCUE-ALS Phase 2 clinical trial data. In particular, the treatment significantly extended the time to disease progression —…

Brainstorm Cell Therapeutics‘ investigational cell-based therapy, NurOwn, might be able to slow disease progression and be of “meaningful” benefit to  people with less severe amyotrophic lateral sclerosis (ALS), according to new analyses of Phase 3 trial data. The company announced last year that its Phase 3 trial…

Prilenia Therapeutics has raised $43 million to support potential regulatory submissions and marketing of its lead candidate, pridopidine, for the treatment of amyotrophic lateral sclerosis (ALS). The funding, obtained through a Series B financing round, also will be used to support the potential marketing of the candidate therapy for…

A first patient has been enrolled in a Phase 3 clinical trial investigating FNP122, an oral formulation of edaravone being developed by Ferrer to treat amyotrophic lateral sclerosis (ALS). The ADORE trial aims to enroll 300 patients across Europe to assess the safety and efficacy of FNP122, as well as its…

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…

AC Immune has extended its research collaboration with scientists at the University of Pennsylvania (UPenn) working to uncover how TDP-43 protein clumps contribute to different disease manifestations in amyotrophic lateral sclerosis (ALS). In the partnership’s first two years, researchers with the Perelman School of Medicine at UPenn received…

New early clinical study results support the potential of GN-K01, an investigational antibody being developed by GeNeuro, as a treatment for amyotrophic lateral sclerosis (ALS). The therapy may enter clinical trials as early as 2022, according to the company. The antibody targets a viral protein, called HERV-K ENV,…