NEW ORLEANS, LA and LONDON, UK, July 14, 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 was awarded an Innovative Medicines Designation, or Innovation Passport, from the Medicines and Healthcare products Regulatory Agency (MHRA) for its immune-resetting drug candidate, ‘1805, for the treatment of patients with moderately to severely active Rheumatoid Arthritis (RA). The Innovation Passport is the entry point into the Innovative Licensing and Access Pathway (ILAP) in the United Kingdom (UK), designed to accelerate the licensing and access pathway to market for truly innovative medicines.
“Receiving the Innovation Passport Designation is a key regulatory accomplishment with potential to accelerate the development of ‘1805 as a treatment option for people with RA,” said Jonathan Rigby, Chief Executive Officer of Revolo Bio. “It also provides recognition by the MHRA of the unique mechanism of action of ‘1805, which resets the immune system upstream of the inflammatory cascade, with potential to drastically change the treatment landscape for RA patients. We are committed to continue building on the clinical success already demonstrated by ‘1805 for the treatment of RA and preparing for an upcoming Phase 2 trial. This designation provides us the potential to more rapidly bring this innovative product candidate to patients so desperately in need of an effective therapy that does not suppress the immune system.”
‘1805 was awarded the Innovative Medicine Designation for RA based on meeting three criteria: (1) the condition is life-threatening or seriously debilitating; (2) the program is an innovative medicine; and (3) the medicine has the potential to offer benefits to patients. The ILAP aims to accelerate the time to market and facilitate patient access to medicines through the development of a product-specific regulatory and licensing roadmap for key milestones, frequent interactions with the review staff at the MHRA and its partner agencies to discuss the drug’s development, as well as reimbursement. The Innovation Passport is awarded by the UK’s ILAP Steering Group. Members of this group consist of representatives from the MHRA, the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), the All Wales Therapeutics group, Toxicology Centre (AWTTC) and the ILAP Patient and Public Reference Group.
‘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.
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 pending evaluation 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 an ongoing 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.
Marylyn Rigby, VP Investor Relations & Marketing
Monica Rouco Molina, Ph.D.