Benzinga - by Vandana Singh, Benzinga Editor.
KalVista Pharmaceuticals Inc (NASDAQ:KALV) released results from the phase 3 KONFIDENT trial demonstrating statistically and clinically significant efficacy of sebetralstat as an oral on-demand therapy for hereditary angioedema (HAE), a disorder characterized by recurrent episodes of severe swelling (angioedema).
KalVista Pharmaceuticals says KONFIDENT trial 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 trial met all primary and key secondary endpoints and demonstrated a favorable safety profile.
HAE attacks treated with 300 mg and 600 mg of sebetralstat achieved the primary endpoint of beginning symptom relief significantly faster than placebo.
Attacks treated with sebetralstat 300 mg or 600 mg achieved a significantly faster time to a reduction in attack severity from baseline, compared to placebo (p=0.0036 for 300 mg and p=0.0032 for 600 mg).
Attacks treated with sebetralstat 300 mg or 600 mg demonstrated a significantly faster time to complete attack resolution than placebo (p=0.0022 for 300 mg and p
The median time to the beginning of symptom relief was 1.61 hours with sebetralstat 300 mg, 1.79 hours with sebetralstat 600 mg, and 6.72 hours with placebo.
Consistent with previous studies, sebetralstat was well-tolerated, with a safety profile similar to placebo. There were no patient withdrawals due to any adverse event, and no treatment-related serious adverse events (SAEs) were observed.
Treatment-related adverse event rates were 2.3% for 300 mg sebetralstat, 2.2% for 600 mg sebetralstat, and 4.8% for placebo.
The company says it looks forward to submitting a new drug application for sebetralstat to the FDA in the first half of 2024 and the EU and Japan later this year.
Price Action: KALV shares are trading 6.61% lower at $14.98 on the last check Tuesday. The stock hit $22.28 during Tuesday’s premarket trading.
Photo: Darko Stojanovic from Pixabay
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