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

Mundipharma acquires all assets and rights related to REZZAYO ® (rezafungin) , reinforcing continued commitment to management of infectious diseases and specialty care therapeutic area24.4.2024 22:01:00 CEST | Press release

Mundipharma* today announced the acquisition of all assets and rights related to rezafungin globally from Cidara Therapeutics. This provides Mundipharma with global ownership of rezafungin including ongoing development and distribution. Rezafunginis a novel once-weekly echinocandin indicated for the treatment of invasive candidiasis in adults.1 Invasive candidiasis, is a severe, life-threatening infection of the bloodstream and/or deep/visceral tissues.2,3 It affects seriously ill people, especially those with a weakened immune systemand the mortality rate can be 40%4 or more.5,6 It can place a large burden on the healthcare system, with the potential for extended treatment regimens and long hospital stays.6 Over the last 15 years, there have been no new treatments and morbidity and mortality rates remain largely the same, indicating the need for alternative treatment options.7,8 “This acquisition places Mundipharma in the best position to realise the full potential of rezafungin inclu

Global Oncology Innovator BeiGene Highlights New Data across Hematology and Solid Tumor Portfolio at 2024 ASCO Annual Meeting24.4.2024 22:01:00 CEST | Press release

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced it will share research outcomes from its broad hematology and solid tumor portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, May 31 - June 4, 2024. “Our presentations at this year’s ASCO highlight the strength of our growing oncology portfolio and our commitment to developing treatments that address the unmet needs of patients with B-cell malignancies and solid tumors,” Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “The exciting data we will share during ASCO showcase BRUKINSA’s uniquely differentiated clinical profile and add to the growing body of evidence supporting its role across the blood cancer treatment paradigm.” BeiGene will share new data for BRUKINSA (zanubrutinib), which add to the robust efficacy and safety evidence differentiating it within the BTK class. Key highlights include: A network meta-analysis co

TSMC Celebrates 30 th North America Technology Symposium with Innovations Powering AI with Silicon Leadership24.4.2024 21:30:00 CEST | Press release

TSMC (TWSE: 2330, NYSE: TSM) today unveiled its newest semiconductor process, advanced packaging, and 3D IC technologies for powering the next generation of AI innovations with silicon leadership at the Company’s 2024 North America Technology Symposium. TSMC debuted the TSMC A16TM technology, featuring leading nanosheet transistors with innovative backside power rail solution for production in 2026, bringing greatly improved logic density and performance. TSMC also introduced its System-on-Wafer (TSMC-SoW™) technology, an innovative solution to bring revolutionary performance to the wafer level in addressing the future AI requirements for hyperscaler datacenters. This year marks the 30th anniversary of TSMC’s North America Technology Symposium, and more than 2,000 attended the event, growing from less than 100 attendees 30 years ago. The North America Technology Symposium in Santa Clara, California kicks off TSMC Technology Symposiums around the world in the coming months. The symposiu

Rimini Street Appoints Steve Hershkowitz as Chief Revenue Officer24.4.2024 18:50:00 CEST | Press release

Rimini Street, Inc. (Nasdaq: RMNI), a global provider of end-to-end enterprise software support, products, and services, the leading third-party support provider for Oracle and SAP software, and a Salesforce and AWS partner, today announced the appointment of Steve Hershkowitz as its new Chief Revenue Officer (CRO). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240424061249/en/ Rimini Street Appoints Steve Hershkowitz as Chief Revenue Officer (Photo: Business Wire) “Steve’s leadership and extensive experience scaling businesses to deliver top-line growth will expand our sales reach to capture new logos and increase our opportunity to provide even greater value to our clients,” said Rimini Street president and CEO Seth Ravin. “The global revenue team and I are excited to work closely together with Steve to drive growth and broader capabilities for our company.” Leading the Next Chapter of Sales Growth and Continued Success f

Hithium Hosts Roundtable at the BNEF Summit New York, Discussing Next Generation Battery Energy Storage System24.4.2024 18:00:00 CEST | Press release

From April 16th to 17th, the BloombergNEF (BNEF) Summit was held in New York, USA. The BNEF Summit brings together energy, finance, and technology professionals to facilitate the exchange of ideas, insights, and connections. This was Hithium's first time attending after its global launch in 2023. Hithium was also invited to host a roundtable discussion on the topic of "Next Generation Battery Energy Storage System: Latest Technology Trends and Impact on Project Economics," led by Hithium Director of Global Applications Engineering, Neil Bradshaw. The discussion focused on the future development trends of energy storage and included insights on Hithium's technology innovations, global application practices, and international development for global energy green transformation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240423336349/en/ BNEF summit roundtable hosted by HiTHIUM (Photo: Business Wire) Hithium’s advantages on

HiddenA line styled icon from Orion Icon Library.Eye