Novartis Announces Failure of Fevipiprant (QAW039) in Phase III LUSTER-1 and LUSTER-2 Asthma Trials

December 17, 2019 /BioonBIOON/ --Novartis(Novartis) recently announced the latest results from the pivotal global Phase III LUSTER-1 and LUSTER-2 studies of fevipiprant (QAW039), a novel asthma medication. These studies investigated the efficacy and safety of fevipiprant, a DP2 receptor antagonist. Pooled analyses showed that during the 52-week treatment period, neither dose of fevipiprant (150 mg/450 mg) met the clinically relevant threshold for reducing the rate of moderate-to-severe exacerbations compared with placebo. The studies included patients with moderate-to-severe asthma whose condition remained inadequately controlled despite treatment with medium-to-high doses of inhaled corticosteroids (ICS) and at least one additional controller medication.AsthmaPatients (GINA Step 4 or Step 5).

Fevipiprant is an investigational, novel, non-steroidal, once-daily medication that blocks the DP2 pathway, which isAsthmaPotential Key Regulators of the Inflammatory Cascade.

Novartis stated that the overall results from the aforementioned two studies do not support fevipiprant inAsthmaFurther clinical development in terms of treatment. In these studies, fevipiprant was generally well tolerated, and treatment-inducedAdverse ReactionsGenerally balanced across groups, comparable to placebo.NovartisDetailed efficacy and safety data from the LUSTER-1 and LUSTER-2 studies are currently being analyzed and will be submitted to upcoming medical congresses.

NovartisJohn Tsai, Global Head of Drug Development and Chief Medical Officer, stated:“Although the results of the aforementioned LUSTER studies evaluating fevipiprant for the treatment of asthma were disappointing, they help us understand”Asthmathe DP2 pathway. We are deeply grateful to all the patients, their families, and investigators who participated in these studies and made significant contributions to them.”

Fevipiprant molecular structure (drugbank.ca)

LUSTER-1 and LUSTER-2 are two replicate studies that are part of the VIBRANT Phase III program. This program also includes the SPIRIT safety study and the supplementary replicate ZEAL-1 and ZEAL-2 studies. In October this year,NovartisThe latest results of ZEAL-1 and ZEAL-2 were announced.

NovartisThe Company will continue to invest in assets in the field of respiratory diseases, including marketed products Xolair® (for severe allergic asthma [SAA] and chronic spontaneous urticaria [CSU]) and Ultibro® Breezhaler®8 (for COPD), as well as investigational drugs QVM1499 (for moderate-to-severe asthma) and QMF14910 (for moderate-to-severe asthma) that are in Phase III clinical development, while continuing to advance includingAsthma, research projects on chronic obstructive pulmonary disease and other high-need areas (such as idiopathic pulmonary fibrosis and sarcoidosis).

Original Source:Novartis provides update on LUSTER Phase III studies in patients with uncontrolled GINA 4/5 asthma