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 and LONDON, Feb. 04, 2022 (GLOBE NEWSWIRE) — 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