- BioCryst Pharmaceuticals Inc BCRX has announced 96-week data from the Phase 3 APeX-2 trial for Orladeyo (berotralstat), showing a sustained reduction in hereditary angioedema (HAE) attacks patients.
- The HAE patients who were randomized to receive 150 mg of oral, once-daily Orladeyo at the start of the trial had an 80% average reduction in their mean attack rate per month during weeks 25-96 of the trial, compared to baseline.
- Median attack rates also decreased from 2.7 attacks/month at baseline to 0.0 attacks per month in 16 of 17 months through the same period.
- Orladeyo was generally well-tolerated during the treatment period, with fewer drug-related adverse events reported in part 3 (weeks 49-96) as compared to part 1 (weeks 0-24) and part 2 (weeks 25-48). 81% of the patients who entered part 3 completed the trial.
- The new data also showed a reduction in on-demand medication use in HAE patients treated with Orladeyo.
- Orladeyo demonstrated consistently low attack rates in adolescent patients (ages 12-17), with the mean attack rate at week 4 was 0.4 attacks/month, which was generally sustained through week 48.
- Median attack rates in these adolescents were 0.0 attacks/month throughout the 48 weeks of treatment.
- Over 70% of patients were attack-free in weeks 4 to 48.
- Price Action: BCRX shares are up 0.85% at $16.50 premarket on the last check Monday.
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