EPIENDO-PHARMACEUTICALS

EpiEndo Pharmaceuticals (www.epiendo.com ), a clinical-stage biopharmaceutical company developing novel non-antibiotic macrolide therapeutics for the treatment of inflammatory disorders, announced today that the first subjects have been dosed in the Company's first-in-human phase I clinical trial of its lead candidate, EP395, at the Medicines Evaluation Unit (MEU) in Manchester, UK (clinicaltrials.gov identification number NCT04819854). The trial is led by Professor Dave Singh, Professor of Respiratory Pharmacology at the University of Manchester and Medical Director at MEU.

“I am delighted to say that our single ascending dose study has started and that the first six healthy subjects have been given a dose of EP395,” commented Dr. Ginny Norris, EpiEndo’s Chief Medical Officer. “The study will now continue with further single dosing and, later, multiple dosing. Dosing of our first subjects with EP395 is an important milestone for EpiEndo, as it brings us one step closer to offering a potentially meaningful therapeutic option to patients with COPD. This study will produce important early clinical data to guide our future development plans and continues to demonstrate EpiEndo’s leadership in development of non-antibiotic macrolides.”

EP395 is an orally active non-antibiotic macrolide therapeutic with potential to become a first-in-class treatment of chronic airway diseases, including chronic obstructive pulmonary disorder (COPD), asthma, bronchiectasis (BE), diffuse pan-bronchiolitis (DPB), as well as other inflammatory disorders. COPD is a chronic inflammatory disorder of the airway caused primarily by exposure to smoke and environmental pollution. EpiEndo is uniquely focused on restoration of epithelial barrier integrity as a causal underlying driver of disease pathophysiology, common across a range of inflammatory conditions.

"The successful treatment of chronic inflammatory airway diseases remains a challenge facing pulmonologists and a major opportunity exists for a safe, disease modifying, orally-available therapeutic,” said Professor Clive Page, OBE, Chairman of EpiEndo. “COPD has risen in incidence to become the third leading cause of death globally, while still today the standard of care provides only temporary, symptomatic relief. After a substantial pre-clinical programme demonstrating the potential of EP395, I am delighted to announce the start of the phase I clinical trial.”

The Company's distinguished scientific team is led by Chief Scientific Officer, Prof. Dr. Michael J. Parnham, a field-leading expert and a former Director of Preclinical Drug Development at GSK, and is supported by global key opinion leaders in the respiratory field.

“Independent of their valuable antibiotic properties, macrolides have potent, multimodal immunomodulatory properties, that have been well-known since their discovery in the 1950s, but their use for chronic conditions remains limited due to antimicrobial resistance concerns,” commented Prof. Dr. Parnham. “Importantly macrolides promote integrity of the lung epithelium as well as suppressing the neutrophilic inflammation that is clinically relevant to COPD, and which is generally resistant to the corticosteroid component of the current "triple therapy" standard of care. Our lead candidate, EP395, has been specifically optimised to eliminate antibiotic properties while accentuating anti-inflammatory effects of macrolides so that it can be widely deployed for long term respiratory conditions while avoiding antimicrobial resistance concerns.”

About EpiEndo Pharmaceuticals (www.epiendo.com )

EpiEndo is a clinical-stage biopharmaceutical company with a unique approach to inflammatory disorders that focuses on the 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. Compromised 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 and other inflammatory airway diseases.

For more information, please visit www.epiendo.com

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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