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The US FDA has cleared Eloxx Pharmaceuticals’ IND for exaluren, an oral small-molecule ribosomal modulator, to treat nonsense-mutation autosomal dominant polycystic kidney disease (ADPKD), enabling the P-II EXPRESS trial to open US sites
The global P-II EXPRESS trial will randomize ~60 adults with PKD1 or PKD2 nonsense mutations (1:1) to exaluren or PBO for 52wks, assessing annualized change in htTKV as its 1EP; first dosing is expected in Q3’27 with topline data in H1’29
Exaluren holds ODD for ADPKD & Alport syndrome in the US & EU
Ref: PR Newswire | Image: Eloxx Pharmaceuticals | Press Release
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The post Eloxx Pharmaceuticals Receives the US FDA’s IND Clearance for Exaluren to Treat Nonsense-Mutation ADPKD appeared first on PharmaShots.