- EVO756 demonstrated an excellent safety profile and was well
tolerated at all doses; pharmacokinetic data supports
once-daily oral dosing
- EVO756 is a potent and highly selective small molecule
antagonist of MRGPRX2
- Evommune to initiate multiple Phase 2 trials
PALO ALTO,
Calf., July 16, 2024 /PRNewswire/ -- Evommune,
Inc., a clinical stage biotechnology company discovering and
developing new ways to treat immune-mediated inflammatory diseases,
today announced positive results of its first-in-human
proof-of-concept study with EVO756. By blocking MRGPRX2 activation
and degranulation of mast cells, EVO756 has the potential to be a
first-in-class oral treatment for a variety of mast cell-mediated
diseases. Evommune is planning to present a comprehensive data
set of this trial at a peer-review scientific meeting in the fall
of 2024.
![Evommune Announces Expanded Strategic Collaboration with Maruho to Develop and Commercialize MRGPRX2 antagonist EVO756 in Greater China and key Asian countries (PRNewsfoto/Evommune, Inc) Evommune Announces Expanded Strategic Collaboration with Maruho to Develop and Commercialize MRGPRX2 antagonist EVO756 in Greater China and key Asian countries (PRNewsfoto/Evommune, Inc)](https://mma.prnewswire.com/media/2366809/evommune_Logo.jpg)
"The data from our proof-of-concept trial
exceeded our expectations, and we now plan to initiate multiple
clinical trials of EVO756, including a Phase 2b study in chronic spontaneous urticaria (CSU)
patients during the first half of 2025," said Eugene Bauer, M.D., Chief Medical Officer at
Evommune. "We believe we have a novel, highly potent and selective
agent that can be orally administered once daily, with broad
opportunity for patients suffering from various mast-cell mediated
diseases."
The proof-of-concept study is a randomized,
double-blind, placebo-controlled single and multiple ascending dose
(SAD and MAD) study in normal healthy adults and assessed the
safety, tolerability, pharmacokinetics and pharmacodynamics/target
engagement of orally administered EVO756. Doses from 1 mg to 500 mg
were administered in ascending order across 7 cohorts of 8 subjects
each (6 active, 2 placebo). In the MAD cohorts completed to date,
ascending doses of 10 mg, 30 mg, 100 mg and 240 mg BID have been
administered across 4 cohorts of 16 subjects each (12 active and 4
placebo).
The pharmacodynamic potential of EVO756 on mast
cell degranulation was assessed in a skin challenge
test, in which icatibant, a known ligand of the MRGPRX2
receptor, was administered intradermally, resulting in measurable
skin responses in all MAD participants. Multiple experimental
methods have determined that mast cell degranulation caused by
icatibant is representative to changes associated with MRGPRX2
disease-relevant endogenous ligands. This portion of the study
allowed for an evaluation of target engagement and activity in a
highly controlled setting and had the benefit of mimicking the
potential impact of EVO756 versus placebo in inducible
urticarias.
"EVO756's excellent safety profile and potential
for a once daily oral dosing provide continued excitement around
this new class of therapies in inflammatory diseases. As expected,
these data further support the hypothesis that blockade of the
MRGPRX2 receptor and its subsequent downstream effect has the
potential to treat the root cause of inflammation, offering greater
relief than currently available treatments," commented Sarbjit Saini, M.D., Professor of Medicine at
Johns Hopkins University in
Baltimore, Maryland.
About EVO756
EVO756 is a potent, highly selective small
molecule antagonist of mas-related G-protein coupled receptor X2
(MRGPRX2). MRGPRX2 is most abundantly found on mast cells and
peripheral sensory neurons. MRGPRX2 can trigger IgE-independent
activation (degranulation) via multiple ligands, which can lead to
a variety of symptoms depending on the tissue that is affected.
Evommune's pre-clinical data demonstrates that by blocking
activation of MRGPRX2 and degranulation of mast cells, EVO756 has
the potential to be a first-in-class oral treatment for a variety
of mast cell mediated diseases. In addition, due to its unique
function on peripheral sensory neurons, EVO756 could provide fast
relief of itch associated with inflammatory diseases, such as
atopic dermatitis.
About Evommune, Inc.
Evommune, Inc., a Palo Alto based biotech
company, is creating game-changing science to treat immune-mediated
inflammatory diseases by discovering, developing, and delivering
therapies that address symptoms and halt progressive disease. For
more information, please visit Evommune.com.
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SOURCE Evommune, Inc