BioCentury
ARTICLE | Clinical News

Solorel macimorelin: Phase III

September 5, 2011 7:00 AM UTC

Top-line data from an open-label, U.S. Phase III trial in about 100 subjects showed that a single dose of 0.5 mg/kg oral AEZS-130 met the primary endpoint of >90% sensitivity and specificity for diagnosing AGHD. Additionally, the study met the secondary endpoint of correctly classifying 8 of 10 AGHD patients by an undisclosed pre-specified peak GH threshold level set by FDA. AEZS-130 was well tolerated. The study enrolled about 50 patients with confirmed AGHD and about 50 healthy subjects matched to patients for age, gender, body mass index, and estrogen status for females. Aeterna received an SPA from FDA for the trial late last year (see BioCentury, Jan. 3). AEZS-130 has Orphan Drug designation in the U.S. to diagnose GHD.

The company reported interim data from the trial last October showing that AEZS-130 had a higher sensitivity and specificity vs. the previous standard diagnostic test of IV Geref, a growth hormone releasing hormone ( GHRH) plus arginine (see BioCentury, Oct. 11, 2010). Geref was withdrawn from the market in 2008 by Merck Serono S.A., a unit of Merck KGaA (Xetra:MRK, Darmstadt, Germany). ...