Double Whammy For ALS As AbbVie/Calico And Denali Drugs Fail

Two treatments that target elF2B, a regulator of the integrated stress response that appears to be overactive in the progressive motor neurone disease, have missed their primary and secondary endpoints in a landmark platform trial.

Physiotherapist assisting a patient with Amyotrophic Lateral Sclerosis
• Source: Alamy

The amyotrophic lateral sclerosis (ALS) pipeline has suffered a series of setbacks recently and two separate candidates from AbbVie/Calico Life Sciences and Denali Therapeutics that have the same of mechanism of action are the latest to fall by the wayside.

More from Clinical Trials

Novo Scores Cardio Wins But Lilly Still Tipped To Take GLP-1 Crown

 

Novo’s semaglutide has shown its benefits as an injectable in patients with peripheral arterial disease and as an oral agent in cardiovascular outcomes, but stronger results are expected soon from Lilly’s tirzepatide.

Pipeline Watch: Seventeen Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

RemeGen Fast-Tracks Potential World-First BLys/APRIL Agent For gMG In Global Phase III Trial

 

RemeGen is planning to complete enrolment in the global Phase III RemeMG study with telitacicept in generalized myasthenia gravis by the end of 2025 or early 2026. The Chinese firm has already sidelined two other global Phase III trials with the molecule to prioritize the indication.

Equillium Seeks Accelerated Approval For GVHD Drug Despite Primary Endpoint Miss

 

The biotech is banking on itolizumab’s longer-term efficacy as well as unmet need in frontline acute graft-versus-host disease as it prepares to meet with the FDA.

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Equillium Seeks Accelerated Approval For GVHD Drug Despite Primary Endpoint Miss

 

The biotech is banking on itolizumab’s longer-term efficacy as well as unmet need in frontline acute graft-versus-host disease as it prepares to meet with the FDA.

Unicycive Approaches Its First Approval, But In A Competitive Space

 

The company is planning to launch oxylanthanum carbonate for chronic kidney disease patients on dialysis with hyperphosphatemia.

Soleno’s Vykat Gains First Prader-Willi Syndrome Approval, Rivals To Follow

 

After a long wait for patients, Vykat has become the first drug approved for Prader-Willi syndrome symptoms, opening the market up for Soleno and future challengers.