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NEWS
COSCIENS Biopharma Inc. Announces Top-Line Results of Phase 3 DETECT-Trial for the Diagnosis of Childhood-Onset Growth Hormone Deficiency
COSCIENS Biopharma Inc. (NASDAQ: CSCI) announced top-line results for its Phase 3 DETECT-trial evaluating macimorelin for diagnosing Childhood Onset Growth Hormone Deficiency (CGHD).
The study did not meet its primary efficacy endpoint as defined in the protocol, despite macimorelin demonstrating its ability to stimulate growth hormone release. The trial enrolled 102 subjects aged 3 to 17 yearsacross multiple countries.
Key findings include:
An unexpectedly high 'optimal' growth hormone cut-off point of 25.59 ng/mL
Potential high false positive rate from comparator tests (arginine and clonidine)
Confirmation of macimorelin's safety in the pediatric population
The company plans further analysis of the results and discussions with health authorities to determine the next steps for macimorelin in CGHD diagnosis.
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Trytosaveabit : Not looking to great right now?
Jaguar8 OP Trytosaveabit : Looks like it. Didn’t meet primary endpoint. It could have been a very good study.
Trytosaveabit Jaguar8 OP : Well it looks like they will continue with it for now at least and make some adjustments
Jaguar8 OP Trytosaveabit : Yes. Too high of the cut-off point. They can tweak it for macimorelin. Usually before this study, they use either the insulin tolerance test, the glucose stimulation test, or the clonidine or arginine stimulation test.
Trytosaveabit Jaguar8 OP : Knew I could count on you!
Jaguar8 OP Trytosaveabit : You know i love pediatrics- kids like me![[undefined]](https://static.moomoo.com/nnq/emoji/static/image/default/default-black.png?imageMogr2/thumbnail/36x36 "undefined")
![[undefined]](https://static.moomoo.com/nnq/emoji/static/image/default/default-black.png?imageMogr2/thumbnail/36x36 "undefined")