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EpiEndo Receives CTA Approval from UK MHRA for First-in-Man Trials of Lead Compound EP395

Updated: Feb 24

REYKJAVIK, ICELAND - 5 January 2021 - EpiEndo Pharmaceuticals (www.epiendo.com) announced today that the Company has received approval of its Clinical Trial Application (CTA) from the UK Medicines & Healthcare Products Regulatory Agency (MHRA) to commence phase 1 clinical trials of EP395, the Company's lead compound. EP395 is a non-antibiotic 15-membered macrolide in development for the treatment of respiratory diseases. EpiEndo Pharmaceuticals is a privately held biopharmaceutical company currently developing a next-generation therapeutic platform for the treatment of inflammatory disorders through addressing underlying causal pathways of disease.


"This is a major milestone for EpiEndo Pharmaceuticals allowing us to initiate our phase 1 clinical trial of EP395 with Professor Dave Singh at the Medicines Evaluation Unit in the University of Manchester as Principal Investigator," commented Professor Clive Page OBE, Chairman of the Board of EpiEndo Pharma, "Prof. Singh is internationally recognized for his work on both early and late clinical trials with novel drugs for the treatment of respiratory diseases."


Professor Dave Singh holds the position of Professor of Clinical Pharmacology & Respiratory medicine at the University of Manchester and is a member of the GOLD Science Committee, as well as the Chair of the ERS Airway Pharmacology Group.


EpiEndo Pharmaceuticals will be the first Icelandic drug development company to take a novel drug product into clinical trials, which therefore also marks a major milestone in the history of medical research in Iceland. EpiEndo is a pharmaceutical company developing a proprietary portfolio of drugs to address the huge global burden of chronic respiratory diseases based on research carried out at the University of Iceland over more than a decade.


About EpiEndo Pharmaceuticals (www.epiendo.com)

EpiEndo is a clinical-stage biopharmaceutical company with a unique approach to inflammatory disorders through focusing on enhancement of epithelial barrier integrity as a causal pathophysiological factor underlying the etiology of a number of major diseases. Epithelial cells are a key component of the barrier that makes up human skin and lung tissue, as well as the intestinal tract and genitalia. Comprise of the integrity of this barrier is implicated in the progression and non-resolution of inflammation. EpiEndo is developing a proprietary portfolio of orally available macrolide drug candidates with promise as first-in-class disease-modifying therapeutics, to address the huge global burden of chronic respiratory diseases and other significant unmet medical needs. EpiEndo’s lead drug candidate, EP395, aims to be the first on-market oral, disease modifying, non-antibiotic, barrier strengthening and anti-inflammatory macrolide for COPD. For more information, please visit www.epiendo.com

Contact Maria Bech

CEO E-mail: maria.bech@epiendo.com

Tel: [+44] 208 133 8664


Forward-Looking Statements

This press release may contain certain forward-looking statements concerning the financial condition, results of operations and businesses of the Company. All statements other than statements of historical fact are, or may be deemed to be, forward-looking statements. Forward-looking statements are statements of future expectations that are based on management’s current expectations and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in these statements. All forward-looking statements contained in this press release are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. You should not place undue reliance on forward-looking statements. Each forward-looking statement speaks only as of the date of this presentation. The information in this presentation is subject to updating, completion, revision, further verification, and amendment without notice and the Company does not undertake any obligation to publicly update or revise any forward-looking statement as a result of new information, future events or other information.

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