PIN-201104

GAITHERSBURG, Md. and CAMBRIDGE, United Kingdom, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Revolo Biotherapeutics (“Revolo” 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 the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ‘1104, a first-in-class immune-resetting peptide being developed as a potential treatment for eosinophilic esophagitis (EoE). Revolo submitted its original request prior to the initiation of its Phase 2a EoE study (RVLO 121-04) and submitted an amended request following positive results from an additional Phase 2 study. The FDA grants ODD status to support the development and evaluation of potential new medicines intended for the treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Revolo believes that this ODD reflects the potential for ‘1104 to address a critical unmet need for people living with EoE. “We are excited that the FDA has granted ODD for ‘1104 in EoE, as there remains a significant unmet need for new treatment innovations for people living with this disease,” said Woody Bryan, President and Chief Executive Officer of Revolo Biotherapeutics. “We look forward to initiating a Phase 2b study of ‘1104 in EoE later this year.” Evan Dellon, M.D., MPH, Gastroenterologist, Professor of Medicine and Adjunct Professor of Epidemiology at the University of North Carolina Chapel Hill, and Principal Investigator for the Phase 2a clinical trial, added, “’1104 is a promising EoE therapeutic with a novel mechanism of action. Based on the proof-of-concept data from the Phase 2a study, I am eager to see this molecule move forward into the next stage of development.” Revolo previously announced data from RVLO 121-04, a proof of concept, two-week, three-dose, Phase 2a clinical trial evaluating the efficacy, safety, and tolerability of ‘1104, in adults with active EoE. The following key observations were made: Patient-reported dysphagia median symptom scores (DSQ) showed a statistically significant improvement from baseline vs. placebo that was sustained for four weeks after the last dose. A statistically significant reduction in eosinophils, CD4+, and CD8+ cells from baseline as measured in esophageal tissue by flow cytometry. A statistically significant increase in T regulatory cells in esophageal tissue and B regulatory cells in the blood, respectively. Based on the results from RVLO 121-04, Revolo plans to initiate a Phase 2b trial of ‘1104 in adults with active EoE in 2024. The trial will evaluate higher dose levels of ‘1104 and a longer duration of therapy. About Eosinophilic Esophagitis (EoE) EoE is a chronic, allergic inflammatory disease that is characterized by the accumulation of eosinophils in the lining of the esophagus. Inflammation caused by immune cells such as T-cells and mast cells results in progressive tissue injury. If not effectively treated, patients with EoE may have difficulty swallowing, chronic pain, malnutrition, and weight loss. About ‘1104 ‘1104 is a first-in-class peptide that is involved in resetting the immune system. Revolo Bio 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 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. 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. ‘1805 is a modified analogue of a key protein in immune function nearing initiation of Phase 2 clinical trial in patients with moderate-to-severe rheumatoid arthritis and a Phase 2a clinical trial for an additional autoimmune indication. 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 . Company Contact Woody Bryan, Ph.D. President and CEO wbryan@revolobio.com Media Contact Monica Rouco Molina, Ph.D. LifeSci Communications +1-929-469-3850 mroucomolina@lifescicomms.com

- New preclinical data further elucidate ‘1805’s mechanism of action in rheumatoid arthritis (RA) - NEW ORLEANS and CAMBRIDGE, United Kingdom, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Revolo Biotherapeutics (“Revolo” 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 new preclinical data on ‘1805 will be presented via two posters at the American College of Rheumatology Convergence 2023 Annual Conference, which is being held November 10–15 at the San Diego Convention Center in San Diego, CA. “These preclinical data provide further insights into ‘1805’s differentiated mechanism of action,” said Jonathan Rigby, Revolo’s Chief Executive Officer. “While current RA treatments can in part ameliorate joint destruction, they are limited in the ability to prevent osteoclast-induced bone destruction. These results highlight the capacity of ‘1805 to ‘reset’ a number of metabolic pathways involved in bone resorption, thus addressing the progressive bone and joint destruction that is a hallmark symptom of RA. In addition, ‘1805 normalizes the expression of genes abnormally activated in cells from RA patients, such as those associated with inflammation. Altogether, the data support the clinical potential of ‘1805 and its further clinical evaluation. We look forward to initiating the Phase 2b clinical trial in the future.” The principal investigator of the preclinical translational studies, Carl Goodyear, Professor of Translational Immunology at the University of Glasgow, UK, said, “The insights we have generated from this work, emphasize how powerful it is to harness physiological pathways aimed at regulating the immune system. Not only can ‘1805 fundamentally alter cell fate decisions within the innate immune compartment, but it has a unique ability to modulate cells from individuals whose compartment has been perturbed by systemic inflammation. We now need to take these studies to the next step and clearly demonstrate ‘1805’s clinical potential.” Poster details: Title:Biologic IRL201805 Drives Differential Cell-contact and Metabolism Transcriptional Profiles in Monocytes from RA Patients Compared to Healthy DonorsPresenter:Yuriko Yamamura, Research Associate (Immunology & Infection), University of GlasgowAbstract #:2149Date/Time:November 14, 2023, 9:00 a.m. to 11:00 a.m. PTSession:Poster Session C Presentation highlights: Preclinical and clinical studies to date have demonstrated that ‘1805 interacts directly with monocytes, cells which play a key role in the initiation of inflammation and bone erosion in RA patients.Gene expression data from RA-derived monocytes and those from healthy donors indicate that ‘1805 upregulates the expression of genes that are downregulated in RA while simultaneously downregulating the expression of genes that are upregulated in RA, such as those involved in inflammatory pathways.The effect of ‘1805 is selective towards “diseased” monocytes, as large gene expression changes were not observed in monocytes from healthy donors. Title:Novel Biologic IRL201805 Inhibits Osteoclastogenesis in Monocytic Cells from RA PatientsPresenter:Yuriko Yamamura, Research Associate (Immunology & Infection), University of GlasgowAbstract #:2150Date/Time:November 14, 2023, 9:00 a.m. to 11:00 a.m. PTSession:Poster Session C Presentation highlights: In RA patients, osteoclasts derived from CD14+CD monocytes (pre-osteoclasts) are associated with a risk of progressive bone and joint destruction, which fundamentally impacts quality of life and often requires subsequent orthopedic surgery.Data from this study suggest that ‘1805 inhibits osteoclast differentiation and activation via modulation of the RANK/RANKL signaling pathway, a key pathway that regulates osteoclast maturation.Evaluation of gene expression showed that exposure of pre-osteoclasts to ‘1805 influenced the expression of multiple other genes involved in osteoclast differentiation.Notably, ‘1805 influenced metabolic pathways critical for bone resorption, such as V-ATPases. This is particularly relevant, as antiresorptive drugs that inhibit V-ATPase activity have become an area of therapeutic development. For more information, or to register for the conference: https://rheumatology.org/annual-meeting 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 BiotherapeuticsRevolo Biotherapeutics is developing therapies that reset the immune system to achieve superior long-term remission for patients with 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, reset the immune system to prevent the chronic pro-inflammatory immune response that results in autoimmune or allergic disease. ‘1104 is a peptide derived from a natural immune-regulatory protein and has recently completed two Phase 2a 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 ContactMarylyn Rigby, VP Investor Relations & Marketingmrigby@revolobio.com Media ContactMonica Rouco Molina, Ph.D.LifeSci Communications+1-929-469-3850mroucomolina@lifescicomms.com