Egetis Therapeutics AB (publ) announced that the first site has been activated in the pivotal ReTRIACt clinical trial for the new drug application (NDA) in the USA for Emcitate. The Company further announced that it now expects topline results from the ReTRIACt study during the first half of 2024 and estimates subsequent NDA submission in the USA in mid-2024, under the fast-track designation. The updated timelines are due to the substantial delay in the study start, and an anticipated higher number of treatment naive patients, which implies a longer trial duration per patient, expected to be recruited in the trial, compared to the original assumptions.

As a consequence of the delay, the build-up of the commercial infrastructure in the US will be aligned with the updated NDA submission timelines and all resources will be focused on the ReTRIACt Study and the upcoming EU submission. Therefore, the in-house Emcitate development of Aladote will be parked, until Emcitate submissions have been completed. The ReTRIACt clinical trials is a pivotal, 16 patients, randomized, placebo-controlled trial for the US NDA for which is Emcitate, being developed for the treatment of monocarboxylate transporter 8 (MCT8) deficiency.

The trial will be conducted across three centers at the Erasmus Medical Center, Rotterdam, the Netherlands, Children's Hospital of Philadelphia, Philadelphia, PA, USA, and Addenbrooke's Hospital, Cambridge, UK. The Company is working diligently with the trial sites to facilitate a smooth and efficient execution of the trial and more than 30 eligible patients have been identified across the three participating sites. In the meantime, the Company continues to finalize the dossier for the MAA in the EU for submission in the early autumn of 2023.