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Sanofi has stopped a pivotal clinical trial of venglustat in autosomal dominant polycystic kidney disease (ADPKD) for futility. The setback comes months after venglustat failed a phase 2 Parkinson’s disease trial but still leaves Sanofi with shots on goal.
Shares in NGM fell 47% in premarket trading. (Getty Images) A phase 2b trial of NGM Biopharmaceuticals’ aldafermin in nonalcoholic steatohepatitis (NASH) has missed its primary endpoint, sending shares in the biotech tumbling. NGM has pulled plans to enter phase 3 in light of the midstage failure of the FGF19 analog. California-based NGM ramped up expectations for aldafermin last year when it delivered midphase data linking the drug to a significant reduction in absolute liver fat content and improvements on a clutch of other measures. Yet, like other NASH drug developers before i...
The inner ear (Public Domain) A phase 3 clinical trial of Otonomy’s Otividex in inner ear condition Ménière's disease has missed its primary endpoint. The setback comes almost four years after the generation of mixed data from two earlier phase 3 studies persuaded Otonomy to roll the dice on another pivotal clinical trial. Investigators randomized 148 patients with Ménière's, an inner ear disease that causes symptoms including vertigo, to receive a single intratympanic injection of a sustained-release formulation of the steroid dexamethasone or placebo. The primary endpoint ass...
(GlaxoSmithKline) A drug that Pfizer passed over but saw a revitalized cancer R&D-focused GlaxoSmithKline jump on for $4.2 billion has come up as a dud in a key trial pitting it against U.S. Merck’s blockbuster Keytruda. That drug, originally known as M7824, now bintrafusp alfa, works as a bifunctional fusion protein immunotherapy. It is designed to combine a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein and to combine co-localized blocking of the two immuno-suppressive pathways: Targeting both pathways aims to control tumor growth by potentially restoring and en...