Egetis Therapeutics provides status update of the pivotal study with Emcitate

June 30, 2021

Egetis Therapeutics AB (publ) (ticker: EGTX) today provided a status update of its leading candidate drug Emcitate where patient recruitment to the Phase IIb/III study TRIAC II is progressing according to plan.

Patient recruitment to the TRIAC II study with Emcitate is progressing well, and the recruitment is expected to be completed in Q4 2021, in line with previous communication.

“I am happy to announce that we continue to recruit patients to the study according to plan. Interim results are targeted to be available in H2 2022 and will be an important step towards regulatory approvals and commercial launch”, said Nicklas Westerholm, CEO of Egetis Therapeutics.

Emcitate, which has Orphan Drug Designation (ODD) in both EU and the US and received a US Rare Pediatric Disease designation (RPD) in November 2020, is developed for the treatment of MCT8 deficiency, a rare congenital disorder of thyroid hormone trafficking with detrimental natural history and no currently available therapy. Approximately 1 in 70,000 males are affected.

About Egetis Therapeutics

Egetis Therapeutics is an innovative, unique, and integrated pharmaceutical drug development company, focusing on projects in late-stage development for treatment of serious rare/niche diseases with significant unmet medical needs in the orphan drug segment. The drug candidate Emcitate is developed as the first potential treatment for patients with MCT8 deficiency, a rare disease with high unmet medical need and no available treatment. A Phase IIb clinical trial has been completed with significant and clinically relevant effects. A pivotal Phase IIb/III early intervention study has been initiated with the first patient dosed in Dec 2020 and interim results are expected in 2022. Emcitate holds Orphan Drug Designation (ODD) in the US and EU and was granted Rare Pediatric Disease Designation by the US FDA in November 2020. The drug candidate Aladote is a first in class drug candidate developed to reduce the risk of acute liver injury associated with paracetamol poisoning. A proof of principle study has been successfully completed and the design of the upcoming pivotal Phase IIb/III study for Aladote has been finalized after completed interactions with FDA, EMA and MHRA. Aladote has been granted Orphan Drug Designation in the US and an application for ODD was submitted in Europe in Q1 2021.

Egetis Therapeutics (STO: EGTX) is listed on the Nasdaq Stockholm main market. For more information, see http:// www.egetis.com/

Egetis Therapeutics provides status update of the pivotal study with Emcitate

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