KalVista reports positive Phase III data for sebetralstat

KalVista Pharmaceuticals (Nasdaq: KALV) shares, which closed Monday at $16.04, were up 37% to $22 in pre-market activity, but fell back almost 13% to $14.01 by late morning today, after it released new research data.

USA and UK-based KalVista announced positive results from the Phase III KONFIDENT clinical trial demonstrating statistically- and clinically-significant efficacy of sebetralstat as oral on-demand therapy for hereditary angioedema (HAE). KONFIDENT was the largest and most representative trial ever conducted in HAE, and included adolescents, patients using long-term prophylaxis, and all attack severities and locations.

The clinical trial met all primary and key secondary endpoints and demonstrated a favorable safety profile. HAE attacks treated with both 300mg and 600mg of sebetralstat achieved the primary endpoint of beginning of symptom relief significantly faster than placebo (p<0.0001 for 300mg, p=0.0013 for 600mg). The median time to beginning of symptom relief was 1.61 hours with sebetralstat 300mg (CI 1.28, 2.27), 1.79 hours with sebetralstat 600mg (CI 1.33, 2.27) and 6.72 hours with placebo (CI 2.33, >12).