Revolo Biotherapeutics Announces US FDA Approval of IND Application for Phase 2 Trial of ‘1104 in Eosinophilic Esophagitis | Revolo Biotherapeutics

Revolo Biotherapeutics Announces US FDA Approval of IND Application for Phase 2 Trial of ‘1104 in Eosinophilic Esophagitis

NEW ORLEANS and LONDON – June 23, 2021 – Revolo Biotherapeutics (“Revolo Bio” or the “Company”), a company developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic diseases, announced today the approval of an investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA) to evaluate ‘1104, the Company’s first-in-class peptide for the treatment of allergic diseases, in a Phase 2 trial for eosinophilic esophagitis (EoE).

“The unique aspect of ‘1104 is that it works upstream in the biological pathway that drives inflammation in allergic diseases like EoE. Our goal is to prevent the inflammation associated with EoE and do this without suppressing the immune system. This approach is novel and unlike current standard of care or other solutions in development for this patient population,” said Jonathan Rigby, Chief Executive Officer of Revolo Bio. “Our data shows that a single dose of ‘1104 reduces levels of eosinophils, lymphocytes, neutrophils and inflammatory cytokines that control inflammation in allergic disease and can increase the number of regulatory T cells, key immune cells responsible for resetting the immune system. We believe that ‘1104 has the potential to revolutionize the treatment landscape for patients with EoE in need of more effective therapeutic options, and many other allergic diseases, and we look forward to advancing this Phase 2 trial as soon as possible.”


“The mechanism of action of ‘1104 involves a novel pathway to potentially reverse allergic inflammation,” said Marc E. Rothenberg, M.D., Ph.D., Advisor to Revolo Biotherapeutics and Director of Cincinnati Center for Eosinophilic Disorders. “Patients suffering from EoE are very much in need of new therapies that can control their disease, and I am excited to see the results of this upcoming Phase 2 study, a randomized, double blind, placebo controlled trial that will evaluate the safety and efficacy of ‘1104 in adults with EoE.”

About Eosinophilic Esophagitis (EoE)

EoE is a chronic, allergic inflammatory disease that is characterized by the buildup of eosinophils in the lining of the esophagus. Patients with EoE may experience difficulty feeding, poor weight gain and trouble swallowing among other symptoms. In the U.S., about 180,000 children and adults live with EoE. No approved treatments exist and standard of care includes steroids, which require frequent dosing and are associated with several unwanted side effects, such as immune suppression. Roughly one third of patients do not respond to any available treatments.

About ‘1104

‘1104 is a first-in-class peptide derived from a natural immune-regulatory protein, mTB Chaperonin 60.1 that is involved in resetting the immune system. Revolo Bio plans to advance ‘1104 through two Phase 2 trials: one in patients with eosinophilic esophagitis and one in patients with allergen sensitivity, while exploring its potential for other allergic diseases.

About Revolo Biotherapeutics

Revolo Biotherapeutics is developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic disease, without the immune system suppression seen with current therapies. Its two drug candidates, ‘1805 and ‘1104, a protein and a peptide respectively, reset the immune system by preventing the chronic pro-inflammatory immune response that results in autoimmune or allergic disease. ‘1805 is a modified analogue of a key protein in immune function and is entering further clinical development for moderate-to-severe rheumatoid arthritis and non-infectious uveitis. ‘1104 is a peptide derived from a natural immune-regulatory protein and is entering phase 2 clinical trials for patients with eosinophilic esophagitis (EoE) and 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

Marylyn Rigby, VP Investor Relations & Marketing
mrigby@revolobio.com

Media Contact

Monica Rouco Molina, Ph.D.
LifeSci Communications
+1-929-469-3850
mroucomolina@lifescicomms.com

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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.

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.

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.

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.

Team Members

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.

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.

Peter Greenleaf

Chairman

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).

Marylyn Rigby

VP 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.

Nancy Vinh

VP 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.

Team Members

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.

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.

Team Members

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.

Team Members

Jones w (woody) Bryan, ph.d.

Chief Business 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.

Team Members

Perry Calias, ph.d.

Chief Operating Officer

Perry Calias, Ph.D., brings over 25 years of experience in pre-clinical and clinical development, CMC and global regulatory submissions across the drug and device sectors of healthcare. He has held numerous executive positions leading clinical and non-clinical operations, with a strong focus on diseases of the central nervous system and rare diseases.

Team Members

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.

Team Members
  • Carrie Vincent: Director, HR & Senior Executive Administration
  • Dr. Jones W. (Woody) Bryan: Chief Business Officer
  • Dr. Roly Foulkes: Chief Scientific Officer
  • Jonathan Gold: Chief Financial Officer
  • Jeff Myers, MD: Chief Medical Officer
  • Marylyn Rigby: VP Marketing & Investor Relations
  • Dr. Perry Calias: Chief Operating Officer