COSCIENS Biopharma Inc. (CSCI) Tuesday said the Phase 3 AEZS-130-P02 study evaluating macimorelin for the diagnosis of Childhood Onset Growth Hormone Deficiency (CGHD) did not meet its primary goal.
In the study, dubbed DETECT-trial, the macimorelin test was compared to current standard growth hormone stimulation tests. Initial review of the results indicated that the comparator tests may have led to a high false positive rate which impacted macimorelin's ability to reach the primary efficacy endpoint.
"It was surprising to see that many subjects, who had been adjudicated as ill (growth hormone deficient) according to the comparator tests arginine and clonidine, showed high growth hormone stimulation following macimorelin. Our team will be further analyzing the detailed data from the DETECT-trial to gain insights into the reasons behind these unexpected results" commented Nicola Ammer, Chief Medical Officer of the Company.
macimorelin is approved in the U.S. and Europe for the diagnosis of patients with adult growth hormone deficiency (AGHD).
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