TheraRadar

Briefs tagged "IBD"

2 briefs

APOLLO-B ATTR amyloidosis ATTR-CM AbbVie Alnylam Amgen Amvuttra Arvinas Attruby BMS Biogen CNS CRISPR Therapeutics Eisai Eli Lilly FDA HELIOS-B IBD IGF-1R J&J Merck Novartis Onpattro Pfizer Regeneron Roche Sandoz Sanofi TL1A TTR Takeda Vertex acoramidis autoimmune biosimilars bispecific cardiovascular clinical trials competitive landscape drug development gene therapy genetics hATTR-PN immunotherapy metabolic oncology ophthalmology patent cliff patisiran protein degradation rare disease regulatory tafamidis trial design vutrisiran
6 min read

When an IBD Trial Is Terminated, the Drug Usually Didn’t Fail

Of 214 industry IBD trials terminated or withdrawn over three decades, only ~23% stopped for efficacy or safety. The rest ran out of patients, money, or corporate priority — the trial failed, not the biology.

We read the sponsor’s stated reason — the ClinicalTrials.gov whyStopped note — on all 214 terminated or withdrawn industry IBD trials. Business and portfolio decisions are the single largest cause (36%); inability to enroll is next (22%). Lack of efficacy (20%) and safety (4%) together are only ~23% — so when an IBD trial is pulled early, ~77% of the time the reason says nothing about whether the drug worked.

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clinical trialstrial designautoimmunedrug development
18 min read

Entyvio: The Only IBD Drug That Stays in the Gut

Eleven years after approval, Entyvio remains the only IBD drug that acts only in the gut — and two large pharma programs have failed trying to replicate it.

Tysabri (natalizumab) blocks α4 integrin broadly — and 541 patients developed fatal brain infections. Entyvio (vedolizumab) blocks only α4β7, which binds MAdCAM-1 on gut endothelium. One Greek letter difference. Over a million patient-years, no REMS, no MRI surveillance. Takeda's $6 billion franchise is built on that subtraction — and on a head-to-head trial where vedolizumab beat Humira directly in ulcerative colitis.

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autoimmunedrug developmentcompetitive landscapeTakedaBiogen

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