GRANIT Study Compares Velsecorat Versus Placebo in Asthma

Treatment with velsecorat, an inhaled nonsteroidal, selective glucocorticoid receptor modulator (SGRM), improved lung function in patients with poorly controlled asthma, according to results from the phase IIb GRANIT trial.

These findings were shared at the American Thoracic Society 2021 International Conference by Geoffrey Chupp, MD, from Yale School of Medicine.

The multicenter, placebo-controlled, double-blind trial enrolled 805 adults with asthma that was inadequately controlled following run-in on low-dose budesonide. A total of 661 patients had completed the study protocol, which included a high percentage of early discontinuations in the placebo group.

Participants were randomized to receive a 12-week regimen of once-daily velsecorat (50, 90, 180, 360, 720 µg) or placebo.

The study’s primary efficacy endpoint was change from baseline in trough FEV1 versus placebo. Researchers also evaluated a composite endpoint of diary variables captured in CompEx (which tracks clinically relevant deteriorations and severe exacerbations through tracking asthma symptoms, night-time awakenings, rescue inhaler use, etc.).

Over the entire treatment period, velsecorat demonstrated a dose-dependent improvement in trough FEV1 from baseline, compared with placebo. However, the change was not significant at week 12.

For velsecorat dose levels of 360 µg and 720 µg, sensitivity analysis showed significant differences in overall treatment trough FEV1 change from baseline, compared with placebo. Velsecorat 360 µg and 720 µg also significantly delayed time to first CompEx event and reduced CompEx annual event rate (hazard ratio = 0.60 with 360 µg; 0.48 with 720 µg).

The researchers added that velsecorat appeared to be safe and well-tolerated.