• Sublingual (SL) formulation of ‘1104 achieved comparable responses to subcutaneous (SQ) and intravenous (IV) injections

• ‘1104 SC and SL dosing options create opportunities for highly differentiated product profiles in eosinophilic esophagitis (EoE) and other allergic diseases versus currently available therapies

• Data provides additional validation for the differentiated upstream mechanism of action (MOA) of ‘1104, already confirmed in the clinic
  

GAITHERSBURG, Md. and CAMBRIDGE, United Kingdom, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Revolo Biotherapeutics Limited (“Revolo”) today announced new preclinical data demonstrating the potential of its lead allergic-disease treatment candidate, ‘1104, as a SL formulation. The data shows that when administered sublingually via a dissolvable tablet in a lung model of allergic disease, ‘1104 achieves comparable positive results across multiple inflammatory immune cells and other markers of allergic inflammation to those seen with SQ or IV injections of ‘1104. Additionally, the data continues to demonstrate the differentiated upstream MOA of ‘1104, restoring immune homeostasis by impacting both the effector and regulatory arms of the immune system with a persistence of effect for multiple weeks.

Specifically, SL dosing of ‘1104 resulted in reduced inflammatory cell infiltration, including eosinophils and neutrophils, comparable to SQ and IV routes. SL dosing of ‘1104 also led to a reduction of key T2 cytokines and allergen specific immunoglobulin (Ig)E, similar to reductions seen with SQ and IV administration.

“If successfully translated to the clinic, a sublingual option could represent a breakthrough in the treatment landscape for people living with EoE and other allergic diseases,” said Kari Brown, M.D., Chief Medical Officer at Revolo. “The differentiated upstream MOA by which ‘1104 acts, alongside a favorable safety profile across multiple Phase 1-2 clinical studies and its potential flexibility in route of administration, highlights its potential use as a future first-line therapy.”

There is a strong need for additional treatment options for patients with EoE and other allergic diseases. Current therapeutics for EoE, the lead indication for ‘1104, include chronic subcutaneous monoclonal antibodies and oral options with significant safety considerations.

Woody Bryan, Ph.D., President and Chief Executive Officer of Revolo, added, “Following data announced earlier this year, which supports the development of a subcutaneous formulation of ‘1104, these positive oral results provide Revolo with an exciting path forward. As we look to the future, we will prioritize the SQ formulation of ‘1104, with plans to initiate a new Phase 2 study in EoE in 2025 and potentially atopic dermatitis. However, we will continue to gather data on the SL formulation in parallel to inform our future strategy, including ongoing discussions with strategic partners. Our goal is to provide people with chronic allergic conditions a new effective and convenient treatment option without the burden of limiting side effects.”

About ‘1104
‘1104 is a first-in-class peptide that is involved in restoring immune homeostasis, uniquely impacting both the regulatory and effector arms of the immune system. Revolo has recently advanced ‘1104 through a Phase 2a trial in eosinophilic esophagitis (EoE) and a clinical mapping study in patients with allergic rhinitis, while exploring its potential for other allergic diseases. Revolo is planning to advance a commercially differentiated subcutaneous dosage form into clinical studies for EoE and other type 2 allergic conditions while advancing development of a sublingual formulation.

About Revolo Biotherapeutics
Revolo is developing therapies that work upstream in the immune cascade for the treatment of allergic and autoimmune diseases, without the immune system suppression seen with current therapies. Its two drug candidates, ‘1104 and ‘1805, a peptide and a protein respectively, restore immune homeostasis to prevent the chronic pro-inflammatory immune response that results in allergic or autoimmune disease. The disease-agnostic mechanism of action of Revolo Biotherapeutic’s assets provides a potential platform for the development of treatments for multiple allergic and autoimmune diseases. For further information, please visit www.revolobio.com.

Company Contact
Woody Bryan, Ph.D.
President and CEO
wbryan@revolobio.com

Media Contact
Michael Rubenstein
LifeSci Communications
+1 561-289-7981
mrubenstein@lifescicomms.com