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Revolo Announces New Preclinical Data Further Validating Atopic Dermatitis as a Target Indication for ‘1104

  • Data continues to differentiate ‘1104 as a potential allergic disease treatment that acts upstream in the immune cascade
  • ‘1104 reduces key indices of skin inflammation and inflammatory mediators in a chronic allergen-driven model of atopic dermatitis (AD)

GAITHERSBURG, MD and CAMBRIDGE, UK, September 18, 2024 /GlobeNewswire/ — Revolo Biotherapeutics Limited (“Revolo”) today announced new data from preclinical studies that validate atopic dermatitis (AD) as a target indication for the Company’s lead clinical asset, ‘1104. The data reinforces the broad clinical applicability of ‘1104, through a novel upstream mechanism of action (MOA), demonstrating its impact across skin disease measures and a wide range of inflammatory cytokines and chemokines associated with AD pathology.

Key results include:

  • In a chronic allergen-driven murine model of atopic dermatitis, ‘1104 significantly reduced skin pathology indicators and serum biomarkers of AD to levels close to naïve control individuals and comparable to positive control individuals treated with the anti-inflammatory dexamethasone.
    • This includes a reduction in skin thickness and a reduction of skin pathology indicators such as erythema and skin erosion.
  • ‘1104 reduced allergen-specific immunoglobulin E (IgE) levels and key T helper 2 (Th2) cytokines in serum, such as interleukin 4 (IL-4), IL-5 and IL-13, in addition to non-Th2 cytokines like tumor necrosis factor (TNF) alpha, IL-1 beta, interferon (IFN) gamma, and IL-17.
  • ‘1104 also reduced key serum biomarkers classically associated with AD pathology such as chemokine ligand 17 (CCL-17), CCL-22, and Th2 cytokine IL-31, which is associated with pruritus and disruption of the skin barrier.

“The ability of ‘1104 to affect a broad range of inflammatory mediators associated with allergic disease, while also impacting disease pathology, is both unique and impressive,” said Kari Brown, M.D., Chief Medical Officer at Revolo. “These new data support the initiation of a clinical trial evaluating ‘1104 in patients with atopic dermatitis. ‘1104 has the potential to offer patients a treatment that addresses the underlying inflammatory response, rather than just targeting inflammation after it occurs, which differentiates it from current treatments.”

Woody Bryan, Ph.D., President and Chief Executive Officer of Revolo, added, “At Revolo, our priority has been to develop a product for patients with allergic diseases that can offer increased efficacy and dosing convenience. This compelling dataset in a preclinical model of atopic dermatitis is yet another convincing validation of the potential that ’1104 has across an array of allergic diseases, including Th-2 and non-Th2 conditions. We look forward to evaluating ‘1104 in a new clinical trial in AD and continuing to build on the positive data shown in the completed Phase 2 study of ‘1104 in eosinophilic esophagitis.”

About ‘1104
‘1104 is a first-in-class peptide that is involved in restoring immune homeostasis, impacting both the regulatory and effector arms of the immune system. Revolo has recently advanced ‘1104 through two Phase 2a trials: one in patients with eosinophilic esophagitis (EoE) and one in patients with allergen sensitivity while exploring its potential for other allergic diseases. Revolo is planning to advance a commercially differentiated subcutaneous dosage form into clinical studies for EoE and other type 2 allergic conditions.

About Revolo Biotherapeutics
Revolo is developing therapies that work upstream in the immune cascade for the treatment of autoimmune and allergic diseases, without the immune system suppression seen with current therapies. Its two drug candidates, ‘1805 and ‘1104, a protein and a peptide respectively, restore immune homeostasis to prevent the chronic pro-inflammatory immune response that results in autoimmune or allergic disease. The disease-agnostic mechanism of action of Revolo Biotherapeutic’s assets provides a potential platform for the development of treatments for multiple autoimmune and allergic diseases.

For further information, please visit www.revolobio.com.

Company Contact
Woody Bryan, Ph.D.
President and CEO
wbryan@revolobio.com

Media Contact
Michael Rubenstein
LifeSci Communications
+1 561-289-7981
mrubenstein@lifescicomms.com

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Jorge De Alba, ph.d.

Vice President, Discovery and Translational Science

Dr Jorge De Alba is an accomplished scientist that brings over 25 years of experience in drug discovery successfully leading preclinical and translational research in the immunology and inflammation space across different biopharmaceutical organizations.

Paul Eggleton, ph.d.

Vice President, Immunology

Professor Paul Eggleton has 30 years of experience working on the immune regulatory function of chaperone proteins in autoimmune, neurodegenerative and inflammatory diseases.  He has work extensively in the field of immunopathology in North America and Europe in medical institutions and the pharmaceutical industry.

Maria Pittaras, pmp

Vice President, Portfolio and Program Management

Maria has over 25 years of experience in the biopharmaceutical industry. She has a successful track record of new product planning, as well as facilitation of cross-functional, high-performing project teams across all phases of drug development from preclinical through commercialization.

David Southwell

Chairman

In addition to his role as Chairman of Revolo, David Southwell serves on the Board of Directors for Rocket Pharmaceuticals and PTC Therapeutics. David is the former CEO of TScan Therapeutics. Before that, he served as President and CEO of Inotek Pharmaceuticals until its merger with Rocket Pharmaceuticals in 2018. David has held other senior leadership roles and Board of Director positions at companies including Human Genome Sciences, Sepracor, Spero Therapeutics, inVentiv Health, and THL Credit.

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Kari Brown, M.D.

Chief Medical Officer

Kari Brown, a board-certified allergist and immunologist, brings 10 years of experience in clinical treatment deployment, development and strategy to Revolo. In her various roles, Kari has played an integral part in advancing pipelines across allergy and immunology disease indications.

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Femi Oluboyede

Vice President, Technical Operations, CMC

Femi Oluboyede has over 20 years of experience within the bio-pharma industry, with a proven track record of achieving strategic corporate objectives. Through his roles, Femi has excelled in fostering alignment across functional teams, including Process Development, Tech-transfers, cGMP Manufacturing in Biologics, Small molecules, Proteins and Synthetic Peptides. He has succeeded in delivering investigational products and providing support across different phases of clinical trials.

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Tunde Otulana, M.D.

Non-Executive Director

Tunde is currently the Chief Medical Officer of Veloxis Pharmaceuticals in North Carolina, USA since August 2020. Prior to Veloxis he was Senior Vice President and Chief Medical Officer at Mallinckrodt Pharmaceuticals. His career, which spans about 30 years in industry, government and academia, includes leadership roles at Boehringer Ingelheim Pharmaceutical Inc. and the US Food and Drug Administration (“FDA”). Tunde is a physician trained in Pulmonary and Critical Care Medicine.

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Beth Alley

Senior Vice President, Regulatory Affairs and Pipeline Planning

Beth Alley has over 20 years of experience within the biopharmaceutical industry in regulatory affairs, commercial strategy, and medical writing throughout all phases of drug development. Her primary areas of focus have been in development of biologics for treatment of autoimmune, inflammatory, and infectious diseases.

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Glen Giovanetti

Non-Executive Director

Glen Giovanetti has more than 35 years of experience in strategy and operational leadership in the life science industry as well as in financial governance, risk and reporting as EY’s Global Biotechnology Sector Leader and Life Sciences Sector Leader. He currently serves on the Board of Directors of Life Science Cares, Teon Therapeutics and XW Pharma.

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Marla S. Persky

Non-Executive Director

Marla S. Persky currently serves as the chief executive officer and president of WOMN LLC. She has more than 25 years of international senior business and legal experience in the pharmaceutical industry having held numerous business and legal positions at Boehringer Ingelheim and Baxter International. She currently serves on the Boards of Directors of Xeris Pharmaceuticals, YGEIA Consulting Group, Primary Stages, World Neighbors and A Better Chance in Ridgefield.

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Dora Rau

Senior Vice President, Quality

Dora Rau brings 25 years of experience in development and commercial operations for drugs, biologics, devices and combination products to the team. She has held numerous executive-level quality positions, with expertise in building quality systems and in leading teams to attain successful regulatory authority inspection outcomes and product approvals.

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Jonathan Gold

Chief Financial Officer

Over the last 25 years, Jonathan Gold has been an institutional venture capitalist, a public fund manager, a founder, an operating executive, and a board member for companies across sectors including life sciences. In those roles, he was active in the development, financing and mergers and acquisitions for numerous public and private companies.

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Michael Albisser

Non-Executive Director​

Michael is a partner of Metellus, a Zurich and London-based venture capital firm investing in technology and life sciences with ground-breaking potential. Having more than 25 years of experience in the finance area he is responsible for finance, tax, and deal structures. He serves on the board of various venture-backed companies.

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Dr. Isaac Cheng, m.d.

Non-Executive Director

Dr. Isaac Cheng is currently an investment professional at Morningside, a venture capital and private equity institution based in Boston USA, and Shanghai China. Dr. Cheng focuses primarily on biopharmaceutical and healthcare investments. He has served on numerous public and private company boards.

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Peter Greenleaf

Non-Executive Director

Peter Greenleaf currently serves as the chief executive officer (CEO) and member of the Board of Directors of Aurinia, (NASDAQ: AUPH / TSX: AUP), an autoimmune therapeutics company. He has held several other CEO and chairman roles. He is also currently a member of the Board of Directors of Antares Pharmaceuticals, Inc. (NASDAQ: ATRS) and Chairman of the Board of Directors of Biodelivery Sciences International, Inc. (NASDAQ: BDSI).

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Marylyn Rigby

SVP of Marketing and Investor Relations

Marylyn Rigby is an experienced pharmaceutical, biotech, and drug delivery professional. In addition to her expertise in marketing, public and investor relations, she has a successful track record with business development, licensing, public and private equity financing, strategy and other key corporate functions.

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Nancy Vinh

SVP of Clinical Operations

Nancy Vinh brings over 20 years of experience in managing early and late phase, international clinical trials for drugs, biologics, cell therapy and combination products across a wide range of therapeutic areas to the team. She has served as head of clinical operations and led registrational and label expansion trials execution.

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Dr. Clare Burgess

Chief Development Officer

Dr. Clare Burgess has 24 years of experience in clinical drug development as a pharmacologist and has worked across a wide range of therapeutic areas within the pharmaceutical industry. She has held multiple leadership roles and has led multidisciplinary teams across the world.

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Jeff Myers, m.d., ph.d

Chief Medical Officer

Jeff Myers, M.D., Ph.D., has 20 years of experience in medical affairs, regulatory and clinical development within the biopharmaceutical industry, with focuses on cardiovascular, pulmonary, oncology, and inflammatory diseases.

Before entering the industry, he practiced as a congenital cardiac surgeon and served as the chief of pediatric cardiac surgery at Massachusetts General Hospital and as Associate Professor of Surgery at Harvard Medical School.

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Dr. Roly Foulkes

Chief Scientific Officer

A true drug discoverer, Dr. Roly Foulkes has 25 years of experience building and delivering innovative therapeutic portfolios within the immunology and inflammatory disease space. He has a strong record advising small and medium sized immunology biopharma companies in developing competitive therapeutic strategies and bringing new innovative molecules to the clinic.

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Jones w (woody) Bryan, ph.d.

President & Chief Executive Officer

Jones (Woody) Bryan, Ph.D., brings almost 30 years of experience in the healthcare industry to the team, having led successful business development operations in both private and public pharma and biotech companies.

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Jonathan Rigby, mba

Group Chief Executive Officer

As employee #1 of Revolo Biotherapeutics in the US, Jonathan Rigby has led the company through substantial and rapid growth. He brings three decades of experience creating value and opportunities for companies in the pharmaceutical, biotech and drug delivery technology industry.

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