Phase II results for Repligen's secretin
RGEN said that preliminary analysis of a U.S. Phase II trial of synthetic secretin in 136 children with autism, the product missed its primary end point of improvement in the Childhood Autism Rating Scale (CARS) score. RGEN said that CARS scores varied widely between baseline and week eight, suggesting that day-to-day variations were captured by the score, and noted that there was a statistically significant improvement in treated patients as measured by the Clinical Global Assessment Score (CGAS), which is performed by the parent. RGEN said that 18% of patients treated with secretin received a score of 1 (very much improved) compared to 5% of placebo patients (p=0.02). Analysis of patients who were given a score of 1 or 2 (much improved) showed a non-significant trend towards improvement for secretin patients (p=0.09). ...