Revolo Announces New Preclinical Data Supporting Subcutaneous ‘1104 for Atopic Dermatitis and Other Clinical Programs

• In allergen-driven models of atopic dermatitis, subcutaneous (SQ) administration of ‘1104 demonstrated comparable performance to intravenous administration (IV)
• In multiple preclinical models evaluated in single-dose toxicity studies, there were no ‘1104-related local tolerability adverse effects after treatment with the ‘1104 SQ formulation at dose levels substantially higher than planned for clinical evaluation
• Data reinforces Revolo’s commitment to prioritizing SQ ‘1104 in clinical studies

GAITHERSBURG, Md. and CAMBRIDGE, United Kingdom, Dec. 12, 2024 (GLOBE NEWSWIRE) — Revolo Biotherapeutics Limited (“Revolo”) today announced new preclinical data demonstrating that subcutaneous (SQ) administration of ‘1104 performed comparably to intravenous (IV) administration in allergen-driven models of atopic dermatitis (AD), effectively reducing key markers of skin inflammation and inflammatory mediators, with excellent local tolerability.

“The comparable and consistent response of SQ and IV dosing of ‘1104 in AD, now observed across multiple disease models, reinforces our commitment to prioritizing a SQ formulation in our clinical studies,” said Woody Bryan, Ph.D., President and Chief Executive Officer of Revolo. “Our top priority is to initiate a clinical study with SQ formulation in eosinophilic esophagitis early in 2025, while also planning to evaluate the SQ formulation in a clinical study in AD. Our combined preclinical and clinical datasets continue to demonstrate the disease-agnostic mechanism of action of ‘1104 and its potential for flexible dosing through SQ and sublingual routes. This, together with the upstream mechanism of action and favorable safety, offers a highly competitive profile with the potential to disrupt the current treatment landscape for patients with eosinophilic esophagitis, our lead indication for ‘1104, and other allergic conditions. We look forward to launching Phase 2 trials early next year while continuing productive partnering discussions to advance our growing pipeline.”

Key results when comparing SQ versus IV administration in a murine allergen-driven model of AD:

• Comparable reductions in inflammatory biomarkers in serum, reaching levels similar to naïve control individuals and equivalent to those observed in positive control individuals treated with the anti-inflammatory dexamethasone.
  • This includes key T helper 2 (Th2) cytokines, like interleukin 4 (IL-4), IL-5, and IL-13, to cytokines specific to AD, including CCL17 and CCL22, and IL-31, a cytokine specific to itch, overall consistent with the mechanism of action for ‘1104.
• Comparable reductions in skin pathology indicators were observed, including a reduction in skin thickness and a reduction of skin pathology indicators such as erythema and skin erosion.

Key results of single-dose toxicity studies evaluating tolerability and pharmacokinetics (PK) of the SQ formulation in two preclinical models:

• There were no local tolerability adverse effects (redness or swelling) in preclinical models administered the SQ formulation at dose levels substantially higher than planned for clinical evaluation.
• PK profiles from SQ administration in two preclinical models across a range of doses were dose proportional and showed similar exposure profiles when compared to PK profiles generated from IV administration in prior toxicity studies in the same models and at the same dose levels.

About ‘1104
‘1104 is a first-in-class peptide that is involved in restoring immune homeostasis, impacting both the regulatory and effector arms of the immune system. Revolo 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 is planning to advance a commercially differentiated subcutaneous dosage form into clinical studies for EoE and other type 2 allergic conditions.

About Revolo Biotherapeutics
Revolo is developing therapies that restore immune homeostasis, targeting the immune system upstream for the treatment of autoimmune and allergic diseases. Its two drug candidates, ‘1805 and ‘1104, a protein and a peptide respectively, offer a unique mechanism of action through impact on both the regulatory and effector arms. This upstream, disease-agnostic and dual-action approach results in a rapid and prolonged effect without broad immune suppression, providing a platform for the development of treatments for multiple autoimmune and allergic conditions. Revolo’s assets also have the potential to offer dosing optionality through subcutaneous and sublingual routes, offering a highly competitive profile.

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