The trials -- ELOWEN-1 and ELOWEN-2 -- are designed to evaluate the drug in people living with lupus who experience active skin manifestations
The first Phase III and second Phase III trials will be multi-centre, randomised, assessor-blind, active-comparator studies to determine the efficacy, safety and tolerability of orally administered Zintrodiazine
The study is being conducted through its Japan-based pharmaceutical arm, Asahi Kasei Therapeutics Corp
The CE Mark builds on the company’s ISO 13485 certification, further strengthening confidence in the platform's safety, quality and performance
The partnership aims to accelerate clinical trial timelines, boost data quality, and improve decision-making for sponsors worldwide
The impact on Phase III trials is particularly significant, as these later-stage studies involve larger, committed patient populations and represent years of investment
High-level results from the Phase III OBERON and TITANIA trials revealed that the first-in-class monoclonal antibody reduced the annual rate of moderate-to-severe COPD exacerbations compared with placebo
The document, published under the Accelerating Clinical Trials in the EU (ACT EU) initiative, sets out how trials should be conducted when health emergencies disrupt normal research operations
The licensed intellectual property covers methods and designs for CAR constructs engineered to function in myeloid cell populations
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