Revolo Announces New Data Further Validating the Upstream Mechanism of Action and Subcutaneous Administration of ‘1104
24 Julio 2024 - 7:45AM
Revolo Biotherapeutics Limited (“Revolo”) today announced new data
from preclinical studies and previously completed clinical trials
that further elucidate the upstream mechanism of action (MOA) of
‘1104, which uniquely affects both the effector and regulatory arms
of the immune response.
The data confirms that ‘1104 binds to a novel receptor through
selective upstream binding to allergic antigen-presenting cells
(APCs) which reduces IL-4 and IL-13 signaling pathways. ‘1104 also
rapidly upregulates activated T regulatory (Tregs) and activated B
regulatory cells (Bregs) for multiple weeks, which can restore
immune homeostasis and support less frequent dosing regimens.
Additional positive animal data assessing a subcutaneous (SC)
dosage form of ‘1104 verifies the continued development of a
differentiated SC commercial formulation. In animal models of
allergic disease, ‘1104 SC delivery performed as well as
intravenous administration. The newly generated data validates the
prioritization of the ‘1104 SC development program, with plans to
initiate bridging clinical studies in 2025.
“It is well documented that targeted downstream therapies can
fail to translate eosinophil reduction at the tissue-level into
meaningful clinical responses, creating a large unmet need for
novel therapies,” said Kari Brown, Executive Vice President of
Clinical Development, Operations and Strategy at Revolo. “We are
excited to shed more light on the upstream signaling pathways
engaged by ‘1104 which show its ability to engage the effector and
regulatory arms of the immune response. These new data demonstrate
the potential of ‘1104 to treat a range of allergic diseases.”
Woody Bryan, President and Chief Executive Officer
of Revolo, added, “At Revolo, our priority has been to develop
a differentiated product for patients with allergic diseases. The
SC administration of ‘1104 will offer a patient-friendly treatment.
Additionally, based on encouraging animal data, we are evaluating
the potential for sublingual administration, which will further
elevate the competitive commercial profile of ‘1104 and improve
patient convenience. We look forward to sharing data in the
future.”
Previously announced positive data that supports the
clinical potential of ‘1104 include:In a Phase 2a clinical
trial (RVLO 121-04) evaluating the efficacy, safety, and
tolerability of ‘1104 in adults with active eosinophilic
esophagitis (EoE):
- Treatment with ‘1104 led to a statistically significant
separation from baseline in key clinical endpoints and a rapid
translation into a clinical response per the patient-reported
outcome of the Dysphagia Severity Questionnaire (DSQ).
- The data substantiates that 1104’s upstream MOA offers a
first-in-class modality that overcomes the shortfall of other
downstream approaches that have impacted histologic endpoints but
failed to show clinical response.
In a Phase 2a trial mapping study in allergic individuals
subjected to nasal and skin allergen challenges (RVLO 121-05) data
demonstrated:
- Rapid reduction (Day 1) in intradermal allergic
inflammation.
- Sustained activation of Tregs and Bregs, providing additional
clinical validation of its MOA with persistence to at least 28
days.
About ‘1104‘1104 is a first-in-class peptide
that is involved in restoring immune homeostasis. 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 SC dosage form into clinical studies for EoE and
other type 2 allergic conditions.
About Revolo BiotherapeuticsRevolo is
developing therapies that work upstream in the immune cascade for
the treatment of 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,
restore immune homeostasis 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.For
further information, please visit www.revolobio.com.
Company ContactWoody Bryan, Ph.D.President and
CEOwbryan@revolobio.com
Media ContactMichael RubensteinLifeSci
Communications+1 561-289-7981mrubenstein@lifescicomms.com