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Cytokinetics terminates Phase III program in ALS
Cytokinetics will discontinue its Phase III program of reldesemtiv in ALS after the COURAGE-ALS study met criteria for futility.
ALS Therapy Development Institute develops clinical trial mapping tool
The ALS Trial Navigator helps patients and researchers find relevant amyotrophic lateral sclerosis (ALS) clinical trials worldwide.
ALS: Clene plans 300-patient Phase III trial of CNM-Au8
CNM-Au8 clinical advisor Matthew Kiernan previews Clene’s planned Phase III ALS trial design, including biomarkers and target population.
NeuroSense makes key progress in Phase II ALS trial
NeuroSense is investigating PrimeC in a Phase IIb trial targeting ALS as the company looks to compete in a crowded drug development field.
Medidata and Project ALS partner to develop new therapeutic strategies
Medidata, a subsidiary of Dassault Systèmes, and Project ALS have entered a research partnership in order to develop new therapeutic strategies for the treatment of Amyotrophic lateral sclerosis (ALS).
AI Therapeutics reports promising Phase II data in ALS
AI Therapeutics reported positive data in a small trial targeting a genetic form of ALS, setting the stage for possible further development.
New biomarker data supports NeuroSense’s ALS drug
NeuroSense’s ALS drug Prime C regulated iron levels, which are thought to be associated with improved survival rates and disease mitigation.
FDA AdCom overwhelmingly supports accelerated approval for Biogen’s tofersen in ALS
AdCom panelists backed an accelerated approval for Biogen’s tofersen in a rare form of ALS based on a new surrogate biomarker.
NeuroSense previews Phase IIb trial plans for oral ALS drug
NeuroSense CEO Alon Ben-Noon reveals the target patient population and outcome measures of a planned Phase IIb ALS trial to Clinical Trials Arena.
ALS iNVOLVE/eNGAGE app to track ALS progression in clinical trials
The ALS Never Surrender Foundation has received a $300,000 grant from the ALS Association to support the iNVOLVE/eNGAGE app for the condition.
Health Canada approves third stage of ProJenX’s ALS trial
The health authority has given the go-ahead for Part 1c of the PRO-101 trial investigating the use of prosetin in participants with ALS.
Results of HEALEY ALS trials show progress in the field
There are seven regimens in HEALEY ALS Platform Trials, with five completed and two trials recruiting patients at Phase III.
Ionis begins clinical trial of antisense medicine for ALS treatment
Ionis Pharmaceuticals has initiated a Phase III clinical trial of antisense medicine ION363 in patients with amyotrophic lateral sclerosis (ALS) with mutations in the fused in sarcoma gene (FUS).
Spinogenix receives HREC approval to initiate human trials of ALS drug
SPG302 showed improvements in cognition and motor behaviors in several animal models of neurodegenerative disorders.
Mapping Endpoints: How to build an ALS clinical trial
Differing endpoint and efficacy expectations can make designing an ALS clinical trial challenging. Clinical Trials Arena looks at ways to dampen drug development obstacles.
Prilenia envisions Phase III trial despite ALS drug missing primary endpoint
Prilenia has announced plans to initiate a Phase III trial in H2 2024 after presenting results at the Annual California ALS Research Summit in Los Angeles, US.
FDA to hold Advisory Committee meeting for BrainStorm’s NurOwn in ALS
In a surprising about-face, the FDA will convene an Advisory Committee to review BrainStorm Cell Therapeutics’s stem cell therapy NurOwn for ALS.
Biogen reports positive data from Phase I/II study of tofersen
Biogen has reported positive results from interim results of phase I/II trial of tofersen which is being studied to treat amyotrophic lateral sclerosis (ALS) in adults with a confirmed superoxide dismutase 1 (SOD1) mutation.
ProJenX doses first subject in Phase I ALS trial
The trial will assess prosetin’ safety, tolerability, pharmacokinetics and pharmacodynamics in healthy subjects and ALS patients.
ALS clinical trials: How stem cells could fuel biomarker development
BrainStorm Cell Therapeutics is generating stem cells to test its ALS drug in a genetic subpopulation after missing the mark in a Phase III trial.