Triac Trial II (clinicaltrials.gov identifier NCT02396459) is an ongoing international, open label, multi-center study in children with MCT8 deficiency, conducted in both
The recruitment target of 16 patients has been met in the Triac Trial II clinical study but to include additional patients who has already been identified but not yet screened, the trial will remain open for recruitment a few additional weeks. Results of Triac Trial II are expected in the first quarter of 2024 and are expected to be submitted post-approval to regulatory authorities.
Data from preclinical studies suggest that Emcitate restores abnormal neuronal development and myelination in animal models of MCT8 deficiency if given in early postnatal life. In the Triac Trial I study, effects on neurocognitive development were included as exploratory endpoints (in a subset of patients) andthe results indicate a potential for Emcitate to positively influence neurocognitive development when treatment is introduced early, with the largest increase in gross motor function seen in patients where treatment was started before the age of 4 years.
As a result of fruitful regulatory interactions, Egetis intends to submit a marketing authorisation application (MAA) for Emcitate to the
In the US, after discussions with the FDA, Egetis will conduct a small randomized, placebo-controlled study in 16 patients to verify the results on T3 levels seen in previous clinical trials and publications. Egetis intends to submit a new drug application (NDA) in the US for Emcitate in mid-2023 under the Fast-Track Designation granted by FDA. Emcitate has been granted Rare Pediatric Disease Designation (RPD) which gives Egetis the opportunity to receive a Priority Review Voucher (PRV) in the US.
For further information, please contact:
Tel. +46 (0) 733 542 062
nicklas.westerholm@egetis.com
Karl Hård, Head of Investor Relations and Communications
Tel. +46 (0) 733 011 944
karl.hard@egetis.com
The information was submitted for publication, through the agency of the contact persons set out above, on
© Modular Finance, source