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Revolo Biotherapeutics Receives MHRA Approval for Two Phase 2 Clinical Trials of ‘1805 in Autoimmune Diseases in the United Kingdom

Company to initiate one Phase 2 trial in rheumatoid arthritis and a second Phase 2 trial in uveitis

NEW ORLEANS, LA and LONDON, UK, February 4, 2022 – 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, today announced that it has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to commence two Phase 2 clinical trials to evaluate its immune-resetting drug candidate, ‘1805, in patients with autoimmune diseases, one in people with moderate to severe active Rheumatoid Arthritis (RA) and a second trial in people with Noninfectious, Active, Intermediate, or Posterior Uveitis or Panuveitis, in the United Kingdom. Revolo is also enrolling patients in two ongoing Phase 2 studies to evaluate its drug ‘1104 in Eosinophilic Esophagitis (EoE) under a U.S. IND in Allergic Disease.

“Given ‘1805’s mechanism of action that resets the immune system upstream of the inflammatory cascade, versus after inflammation has occurred, we believe this molecule has the potential to truly change the treatment landscape for multiple autoimmune diseases,” said Jonathan Rigby, Chief Executive Officer of Revolo Bio. “We look forward to building on the promising clinical profile from our first Phase 2a trial of ‘1805 in patients with RA and continue to show its clinical potential in other autoimmune diseases with high unmet needs, such as Uveitis, the leading cause of adult blindness in western countries. We plan to begin dosing of patients as soon as possible.”

Data from a previous Phase 2a trial investigating ‘1805 in 24 patients with severe RA nonresponsive to standard of care demonstrated its potential as a safe and effective treatment, including rapid onset (week 3) and sustained remission (12 weeks) following a single intravenous (IV) dose.

Revolo Bio’s Phase 2 trial in RA is a randomized, double-blind, placebo-controlled, dose-escalation study to investigate the effects of ‘1805 in patients with moderate to severe active RA. The study aims to enroll 92 patients and will last 24 weeks split into a 12-week treatment period and a 12-week follow-up period. ’1805’s efficacy in RA will be tested at doses of 15 mg, 50 mg, or 100 mg administered by IV bolus.

The second Phase 2 study is a prospective, open-label, dose-escalation study to evaluate the safety and efficacy of ‘1805 in patients with Noninfectious, Active, Intermediate, or Posterior Uveitis or Panuveitis. The study aims to enroll 25 patients in a 16-week trial with the primary efficacy endpoint of clinical response measured at week 12. ’1805’s safety and efficacy in Uveitis will be tested at doses of 15 mg, 50 mg, or 100 mg administered by IV bolus.

About ‘1805

‘1805 is a modified analogue of the endogenous immune-regulatory binding immunoglobulin protein (BiP), a key player in immune function that resets the immune system for long-term disease remission. Its mechanism of action creates vast optionality across multiple indications and routes of administration.

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 to prevent 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 being evaluated in a second Phase 2 clinical trial for moderate-to-severe rheumatoid arthritis and a Phase 2 clinical trial for non-infectious uveitis. ‘1104 is a peptide derived from a natural immune-regulatory protein and is being evaluated in a Phase 2 clinical trial for patients with eosinophilic esophagitis (EoE) and a Phase 2 clinical trial for 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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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.

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.

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

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

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

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. 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.

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

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).

Beth Alley

VP of Regulatory Affairs

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.

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.

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.

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

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.

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.

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.

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