Business Wire

EpiEndo Pharmaceuticals Announces Launch of First-in-Human Clinical Trial of a Non-Antibiotic Macrolide for the Treatment of Chronic Inflammatory Airway Diseases

Share

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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

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

EpiEndo Pharmaceuticals
E-mail: info@epiendo.com
Tel: [+354] 454 0090

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

H.I.G. Capital Announces the Sale of DGS S.p.A.11.6.2024 12:00:00 CEST | Press release

H.I.G. Capital (“H.I.G.”), a leading global alternative investment firm with $62 billion of capital under management, is pleased to announce that an affiliate has signed a definitive agreement to sell its portfolio company, DGS S.p.A. (“DGS” or the “Group”), a leading firm in the Italian Information Technology market, to DGS Co-Founders and management team in partnership with ICG, a global alternative asset manager. Since its inception in 1997, DGShas supported blue-chip customers in the design, integration, and maintenance of complex IT systems, with a specialization in digital transformation and cybersecurity services. The Group currently has over 1,900 employees, revenues of approximately €300 million, and maintains a group of highly loyal clientele. During H.I.G.’s ownership, DGS has tripled in size and consolidated its position as a leading Italian firm in cybersecurity services and digital transformation. DGS offers its clients sophisticated and proprietary digital transformation

Evertas Names Nick Selby Head of European Underwriting11.6.2024 12:00:00 CEST | Press release

Evertas, the world’s first crypto insurance company, has named Nick Selby as its new Head of European Underwriting. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240611141887/en/ Nick Selby, Executive Vice President and Head of European Underwriting at Evertas (Photo: Business Wire) Selby, an accomplished information and physical security professional, brings two decades of expertise in public and private sector information security, physical security, and complex incident handling, as well as seven years of experience leading teams securing billions of dollars in cryptoassets. Previously, his roles included VP of the Software Assurance Practice at Trail of Bits, Chief Security Officer at Paxos Trust Company, and Director of Cyber Intelligence and Investigations at the NYPD Intelligence Bureau. “Nick is an extremely valuable addition to our European team,” said Evertas CEO and Co-Founder J. Gdanski. “His public and private

Owlet utvider globalt fotavtrykk med lanseringen av medisinsk-sertifisert Dream Sock™ i Storbritannia og over hele Europa11.6.2024 11:00:00 CEST | Pressemelding

Owlet, Inc. («Owlet» or the «Company») (NYSE:OWLT), pioneren innen smart spedbarnsovervåking, kunngjør i dag den britiske og europeiske lanseringen av Dream Sock. Dette er en smart babymonitor med levende helseavlesninger og varsler for friske spedbarn mellom 0-18 måneder og 2,5-13,6 kg. Dette innovative medisinske utstyret gir foreldre helse og viktig informasjon i sanntid, noe som gir uovertruffen trygghet. Denne pressemeldingen inneholder multimedia. Se hele pressemeldingen her: https://www.businesswire.com/news/home/20240611820341/no/ (Photo: Business Wire) «Vi er svært stolte over å lansere Dream Sock til omsorgspersoner over hele Storbritannia og Europa og gi millioner av foreldre mer trygghet mens babyen sover,» sa Kurt Workman, Owlets administrerende direktør og medgründer. «Dream Sock er nå et globalt produkt som er anerkjent som medisinsk nøyaktig og trygt, etter å ha gjennomgått regulatoriske autorisasjoner og sertifiseringer innenfor flere geografier. I dag er misjonen vår

V-Nova Surpasses 1000 Patent Milestone in Media Technology Innovation11.6.2024 10:00:00 CEST | Press release

V-Nova, a leading provider of data compression solutions, video compression technology, XR technology, AI acceleration and parallel processing for a multitude of industries including media and entertainment, today announced its milestone achievement of 1000 active technology patents. This accomplishment underscores V-Nova’s dedication to research and development and its commitment to protecting its intellectual property globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240611724561/en/ V-Nova’s patent portfolio spans more than 50 different jurisdictions. Including over 400 patents in Europe, over 200 in the Americas, over 100 in the United States specifically, and over 200 in Asia. V-Nova forged new directions in data processing to enhance digital experiences, maximize efficiency, reduce costs, and increase sustainability. The company leads the way with key international data compression standards for the video indust

Alipay+ Reveals Top Scorer Trophy Design for UEFA EURO 2024™11.6.2024 09:24:00 CEST | Press release

Alipay+, a suite of cross-border mobile payment and digitalization technology solutions operated by Ant International and an Official Partner of UEFA EURO 2024™, today revealed the trophy that will be awarded to the most prolific marksman at the UEFA EURO 2024™ finale on July 14 in Berlin, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240610328619/en/ The UEFA Top Scorer Trophy presented by Alipay+ is unveiled for UEFA EURO 2024™ (Photo: Business Wire) Sculpted in the shape of the Chinese character “支” (pronounced zhi, and meaning payment as well as support), the trophy reflects Alipay+’s dedication to supporting consumers to enjoy seamless payment and a broad choice of deals using their preferred payment methods while traveling abroad. The character also resembles the fleeting moment of a barefooted striker poised to shoot, evoking the original beauty and power of football – a game that united people across the wo

World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye