Recent Posts

DBVT fails to achieve 95% lower bound confidence interval in PEPITES

Good news and bad news. The bad: DBVT failed to achieve their primary endpoint. They saw a 21.7% improved response rate with a p-value < 0.00001 but their 95% confidence interval (CI) was 12.4%-29.8%. They needed to reach 15% on the lower bound of the confidence interval, and they were just below that. CIs provide […]

Going Nuts for Oral Immunotherapy – AIMT

Peanut allergy is reported to affect ~3 million Americans and there are approximately 210,000 emergency department visits attributed to food anaphylaxis in the USA per year (Sicherer SH, 2010, Clark S, 2013). Given that the only treatment for accidental ingestion of allergens is intramuscular epinephrine, companies have sought other ways to help patients with peanut […]

AXON – Mindset Trial Results

This morning, Axovant announced that Intepirdine failed to meet both primary objectives in the Mindset trial. The press release said, “After 24 weeks of treatment, change from baseline in cognition was non-significantly improved in the intepirdine arm versus the placebo arm (0.36 ADAS-Cog points; p-value = 0.22). In addition, there was essentially no difference between […]