United States-based Eli Lilly and Company (NYSE: LLY) has announced new safety and efficacy data for mirikizumab in patients with moderately- to severely active Crohn's disease.
It was reported yesterday that Patients treated with mirikizumab in the SERENITY Phase two study achieved significant decrease in clinical and endoscopic measures of disease activity at 12 weeks compared to placebo. The maintenance phase of this study is ongoing.
In this study, patients with moderately- to severely active Crohn's disease were randomised to receive either placebo or one of three doses of mirikizumab, which is an investigational antibody that targets the p19 subunit of interleukin 23. The primary endpoint evaluated mirikizumab versus placebo on endoscopic response, which was defined as a 50% decrease from baseline in the severity of each patient's disease, as measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD)1. Secondary endpoints included clinical remission as measured by Patient Reported Outcomes (PRO remission), endoscopic remission, and safety.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA