COSCIENS Biopharma Inc T.CSCI

Perplexity Ai:

[prophetoffactz]

Based on the press release, it appears that the Phase 3 DETECT trial of macimorelin for diagnosing childhood-onset growth hormone deficiency (CGHD) did not meet its primary efficacy endpoint as defined in the study protocol. However, there are some important points to note:

1. Macimorelin demonstrated its ability to stimulate growth hormone release, which is necessary for a growth hormone stimulation test.
2. The primary endpoint was not met due to unexpected results with the comparator tests (arginine and clonidine), which may have led to a high false positive rate.
3. The optimal growth hormone cut-off point for macimorelin was found to be 25.59 ng/mL, which is much higher than the 7-10 ng/mL cut-off used for existing tests.
4. This unexpectedly high cut-off resulted in failure to meet sensitivity and specificity assessments.
5. The company plans to conduct further analysis of the detailed data to understand these unexpected results.
6. Macimorelin's safety profile in children was confirmed to be excellent, similar to its profile in adults.

While the trial did not meet its primary endpoint as defined, the results suggest that macimorelin may actually be more accurate than the existing tests at identifying true growth hormone deficiency. The high cut-off point and potent growth hormone stimulation seen with macimorelin could indicate that the comparator tests (arginine and clonidine) are over-diagnosing CGHD.The company will need to conduct additional analyses and likely discuss these results with regulatory authorities to determine the next steps. It's possible that with a revised protocol or endpoint definition, macimorelin could still prove to be a superior test for diagnosing CGHD.