08:13 AM EDT, 08/27/2024 (MT Newswires) -- Cosciens Biopharma ( CSCI ) on Tuesday said that top-line results of its Phase 3 DETECT-trial evaluating macimorelin to diagnose Childhood Onset Growth Hormone Deficiency (CGHD) show that the primary efficacy endpoint has not been met.

The macimorelin test was compared to current standard growth hormone stimulation tests (arginine and clonidine). Top-line data presented an 'optimal' growth hormone (GH) cut-off point of 25.59 ng/mL, which is "substantially higher" than the standard cut-off points of 7-10 ng/mL as defined in current guidelines with existing tests.

"This surprisingly high cut-off point leads to a failure in the sensitivity and specificity assessments," the company said. "Sensitivity as well as specificity are important parameters characterizing the performance of a diagnostic test, as they show a test's capabilities to identify ill subjects as being ill (sensitivity) and to identify healthy subjects as being healthy (specificity), respectively."

The completed study enrolled 102 subjects aged three to 17 years at clinical sites in the U.S., Europe and Turkey. Full trial result are slated to be published later this year.

"While we expect the top-line data of our DETECT-trial to be further analyzed and discussed with health authorities, macimorelin is approved in the USA and continues to be marketed in Europe for AGHD," said CEO Gilles Gagnon. "As we get the results of further analysis of the DETECT-trial we will be considering our action plan for macimorelin"In addition, we will continue our ongoing review and prioritization process for Cosciens' pipeline."