Fevipiprant, ZEAL 1 and 2 phase III trials, did not meet the primary efficacy endpoint of FEV1 improvement in moderate asthmatic patients. Novartis

Novartis reported in its financials for Q3 2019 :Fevipiprant (QAW 039) ZEAL 1 and 2 trials did not meet the primary efficacy endpoint of FEV1 improvement in moderate asthmatic patients. The safety profile was confirmed as clean and placebo like.

LUSTER 1 and 2 exacerbation trials in moderate to severe asthmatic patients are the core registration trials and are on track to read out in Q1 2020. The trials each enrolled around 700 patients with uncontrolled asthma and randomized them to take either fevipiprant or placebo once a day on top of standard of care treatment. The primary endpoint looked at change in FEV1 after 12 weeks. Novartis is yet to comment on the secondary endpoints, which tracked metrics including daytime asthma symptom score and quality of life. Fevipiprant improved FEV1 at 12 weeks over placebo in the phase IIb, but details of the data, such as the lack of dose response, left scope to doubt whether it would succeed in phase III.