ARTICLE | Clinical News

Macimorelin: Interim Phase III data

October 11, 2010 7:00 AM UTC

Interim data from an open-label, crossover, U.S. Phase III trial in 42 patients with confirmed AGHD or multiple pituitary hormone deficiencies and 10 healthy volunteers showed that growth hormone stimulation with oral AEZS-130 had 95% sensitivity and 90% specificity for identifying patients who should receive therapy for AGHD vs. 86% sensitivity and 90% specificity with the previous standard diagnostic test consisting of IV growth hormone releasing hormone ( GHRH) plus arginine. Data were presented at the Growth Hormone Research Society and the Insulin-like Growth Factors Society meeting in New York.

The company said it plans to recruit an additional 32 control subjects to be matched to the 32 AGHD patients who were not previously matched. Subjects will receive 1 oral dose of AEZS-130 with no crossover due to the unavailability of GHRH in the U.S., which was withdrawn from the market in 2008 by Merck Serono S.A., a unit of Merck KGaA (Xetra:MRK, Darmstadt, Germany). Aeterna Zentaris said Merck Serono did not disclose the reason for withdrawing GNRH. ...