A game-changing week ahead?While AEZS guided for release of top-line and full data from its pediatric diagnostic trial in Q3, based on the release adult top-line data it could happen this coming week. Could it be a game-changer for the diagnostic which has had a difficult launch in the adult market. Gilles was in the catbird seat at AEZS as a Director and AEZS said it expects a new licensing deal based on its outreach last July. The pediatric market is about the same size as the adult market but some areas of the world only really test for pediatric growth hormone deficiency like China. A higher price could also be charged in the pediatric market given it is an unmet need. With approval for the pediatric market AEZS would be able to market the test to all age categories for the first time and the tests most compelling advantages are in the pediatric market. It can be a challenge to control a child for multiple blood tests and an infusion and AEZS may have the only oral drug and be a standalone test eliminating the need for a second test all together.
Perplexity Ai:
The key points are:
- The DETECT-trial is designed to support the potential for macimorelin to be used as a standalone diagnostic test for CGHD, without the need for additional testing.
- Macimorelin is an oral drug, unlike other growth hormone stimulation tests that require intravenous infusion. This makes macimorelin a more convenient and patient-friendly option.
- Macimorelin is currently the only FDA and EMA approved oral test for the diagnosis of AGHD. If approved for CGHD as well, it would be the industry's first standalone oral diagnostic test for both adult and childhood growth hormone deficiency.
In summary, Aeterna Zentaris is leveraging the clinical success and favorable safety profile of macimorelin to develop it as a potential standalone oral diagnostic test for both AGHD and CGHD, which would be a significant advancement over the current standard of care requiring multiple tests.