WebMar 17, 2024 · The study is also designed to have a pre-planned interim analysis at Week 48 evaluating eGFR slope, supported by a percent change from baseline in proteinuria, in the inaxaplin arm versus placebo. If positive, the interim analysis may serve as the basis for Vertex to seek accelerated approval of VX 147 in the U.S. for patients with AMKD. WebApr 9, 2024 · Official Title: A Phase 2a, Open-label, Single-arm, 2-Part Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-147 in Adults With APOL1-mediated Focal …
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WebJun 9, 2024 · Vertex Pharmaceuticals Incorporated VRTX announced that the FDA has granted Breakthrough Therapy Designation (BTD) to its pipeline candidate, inaxaplin (VX-147) for treating APOL1-mediated focal ... churnjeet mahn strathclyde
Vertex Announces Publication in New England Journal of …
WebJun 8, 2024 · Vertex Pharmaceuticals announced on Wednesday that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to its candidate, inaxaplin (VX-147). Inaxaplin was granted the designation for the treatment of APOL1-mediated focal segment glomerulosclerosis (FSGS). WebApr 6, 2024 · Brief Summary: The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of VX-147 in participants aged 12 years and older … WebDec 1, 2024 · VX-147 was well tolerated. These results provide the first clinical evidence and POC that an oral small molecule APOL1 inhibitor can decrease proteinuria in patients with APOL1-mediated kidney disease. Based on these results, Vertex plans to advance VX-147 into pivotal development in APOL1-mediated kidney disease, including FSGS, in Q1 2024. dfkitcar partial build kits