Egetis announces site activation in the pivotal ReTRIACt trial for Emcitate® and updates timeline for the US NDA submission

Stockholm, Sweden, June 28, 2023. Egetis Therapeutics AB (publ) (Nasdaq Stockholm: EGTX) today 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 Emcitate ReTRIACt study and the upcoming EU submission. Therefore, the in-house development of Aladote will be parked, until Emcitate submissions have been completed.
 
The ReTRIACt clinical trial is a pivotal, 16 patients, randomized, placebo-controlled trial for the US NDA for Emcitate, which is 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 Emcitate for submission in the early autumn of 2023.
 
Nicklas Westerholm, CEO of Egetis, commented: “I look forward to the start of the ReTRIACt trial for Emcitate, but I recognize it has taken a long time to initiate the trial, caused by multiple administrative delays over the past six months. We remain focused on working diligently with the three trial sites to now facilitate a smooth and efficient execution of the trial with our resources directed to the Emcitate ReTRIACt study and the upcoming EU submissions. Our disease awareness activities are bearing fruit and we have identified a large number of treatment naïve patients, primarily in the USA, that could now be eligible for this trial. While positive long-term, both for the patients and for the Company, in the shorter perspective this implies a longer trial duration per patient, which extends the timeline to completion of the study and subsequent submission in the US. For the EU, I look forward to our progress towards submitting the MAA for Emcitate in the early autumn of 2023 as previously communicated.”
 
 
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About the ReTRIACt trial
The ReTRIACt trial (clinicaltrials.gov identifier NCT05579327) is a double-blind, randomized Phase 3 multicenter placebo-controlled study in 16 evaluable male participants diagnosed with MCT8 deficiency. Participants, from 4 years of age and having demonstrated stable maintenance treatment with Emcitate, will be randomized to receive placebo or Emcitate for 30 days or until reaching rescue criterion (serum total triiodothyronine [T3] above upper limit of normal [ULN] of the participant's normal range, for a sample collected during the 30-day Randomized Treatment Period). The research hypothesis to be tested is that, for participants in the placebo group, removal of Emcitate will lead to an increase of serum total T3 concentration above the ULN and requirement of rescue treatment with Emcitate, compared to those who continue to receive tiratricol.