Novartis has announced that a recent pooled analysis from its Phase III LUSTER-1 and LUSTER-2 studies does not support further development of its fevipiprant (formerly QAW039).
The pharma giant announced that the intended asthma treatment did not meet its clinically relevant threshold for reduction in rate of moderate-to-severe exacerbation compared to placebo, when evaluated over a 52-week treatment period, for either of the doses.
Because of this, the company has decided to ditch the trial despite the drug being generally well tolerated, with treatment-emergent adverse events generally balanced across groups and comparable to placebo.
While the results are “disappointing”, John Tsai, head global drug development and chief medical officer explained that the data “meaningfully contribute to our understanding of the DP2 pathway in asthma.”
He went on to say the company is “incredibly grateful to all the patients, their families and the investigators who participated in the studies and contributed greatly to this research,” and that it continues to invest into respiratory medicines with in-market products Xolair (omalizumab) and other Phase III investigational products, QVM149 and QMF149.
Detailed efficacy and safety data from the LUSTER-1 and LUSTER-2 studies are still being analysed according to Novartis, and will be submitted for presentation at an upcoming medical congress.
The severity of asthma ranges between mild, moderate and severe, with more severe asthma requiring more treatment to control symptoms and exacerbations, and despite the availability of standard-of-care asthma treatments for the moderate-to-severe asthma patients, over 45% at GINA Step four and five patients - severe versions of the condition - remain uncontrolled.