Cosciens Biopharma says primary efficacy endpoint of DETECT-trial not met

Cosciens Biopharma announced the top-line results of its Phase 3 safety and efficacy study AEZS-130-P02, “the “DETECT-trial” evaluating macimorelin for the diagnosis of Childhood Onset Growth Hormone Deficiency or “CGHD” . While top-line data show that macimorelin repeatedly demonstrated its capacity to stimulate growth hormone release as required to perform a growth hormone stimulation test, the primary efficacy endpoint for the DETECT-trial has not been met according to the definitions in the study protocol. In the study, the macimorelin test was compared to current standard growth hormone stimulation tests, arginine and clonidine .Although further analysis of the study results is required, initial review of the results indicates that the comparator tests may have led to a high false positive rate which impacted macimorelin’s ability to reach the primary efficacy endpoint. These unexpected results require further clarification and some re-analyses with the aim to consider the trial outcome and the strategy moving forward…”The top-line results confirm the excellent safety of macimorelin, similar to what was demonstrated in our clinical and commercial experience with the use of macimorelin to diagnose adult growth hormone deficiency AGHD . However, it was surprising to see that many subjects, who had been adjudicated as ill or 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.