Egetis to participate at upcoming medical conferences

Stockholm, Sweden, August 30, 2022. Egetis Therapeutics AB (publ) (Nasdaq Stockholm: EGTX) today announced that the Company will participate at the following upcoming medical conferences:

Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium
August 30 – September 2, 2022 in Freiburg, Germany

44th Annual Meeting of the European Thyroid Association (ETA)
September 10-13, 2022 in Brussels, Belgium

60th Annual Meeting of the European Society of Paediatric Endocrinology (ESPE)
September 15-17, 2022 in Rome, Italy

17th International Child Neurology Congress (ICNC)
October 3-7, 2022 in Antalya, Turkey

91st Annual Meeting of the American Thyroid Association (ATA)
October 19-23, 2022 in Montreal, Canada

Nicklas Westerholm, CEO, commented: “As we are progressing towards our marketing applications for Emcitate for treatment of MCT8 deficiency in Europe and the US in 2023 it is important we further increase disease awareness of MCT8 deficiency among those doctors who might come across patients suffering from this rare and severe disease.”

About Egetis Therapeutics

Egetis Therapeutics is an innovative and integrated pharmaceutical company, focusing on projects in late-stage development for commercialization for treatments of serious diseases with significant unmet medical needs in the orphan drug segment.
The Company’s lead candidate Emcitate is under development for the treatment of patients with monocarboxylate transporter 8 (MCT8) deficiency, a highly debilitating rare disease with no available treatment. In previous studies (Triac Trial I and a long-term real-life study) Emcitate has shown highly significant and clinically relevant results on serum T3 levels and secondary clinical endpoints. As a result of fruitful regulatory interaction Egetis intends to submit a marketing authorisation application (MAA) for Emcitate to the European Medicines Agency (EMA) in the first half of 2023 based on existing clinical data.
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 is currently being investigated in the Triac Trial II, a Phase II/III study in very young MCT8 deficiency patients (<30 months of age) exploring potential disease modifying effects of early intervention from a neurocognitive and neurodevelopmental perspective. The recruitment target was achieved in the second quarter 2022 and 22 patients have been included in the study. Results are expected in the first half of 2024 and are expected to be submitted post-approval to regulatory authorities shortly thereafter.
Emcitate holds Orphan Drug Designation (ODD) for MCT8 deficiency and resistance to thyroid hormone type beta (RTH-beta) in the US and the EU. MCT8 deficiency and RTH-beta are two distinct indications, with no overlap in patient populations. Emcitate has been granted Rare Pediatric Disease Designation (RPDD) which gives Egetis the opportunity to receive a Priority Review Voucher (PRV) in the US, after approval.
The drug candidate Aladote is a first in class drug candidate developed to reduce the risk of acute liver injury associated with paracetamol (acetaminophen) poisoning. A proof of principle study has been successfully completed and the design of the upcoming pivotal Phase IIb/III study with the purpose of applying for market approval in the US and Europe for Aladote has been finalized after completed interactions with FDA, EMA and MHRA and study start is planned for later in 2022. Aladote has been granted ODD in the US and has received a positive opinion for ODD in the EU.
Egetis Therapeutics (STO: EGTX) is listed on the Nasdaq Stockholm main market. For more information, see www.egetis.com