Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage
biotechnology company developing a new modality of orally delivered
medicines, today presented full clinical data from the Phase 1b
clinical trial cohort evaluating EDP1815 for the treatment of mild
and moderate atopic dermatitis in a poster presentation at the
International Society of Atopic Dermatitis (ISAD) Hybrid Meeting
2021. The Company previously reported positive data for all 24
patients in the cohort, which is re-iterated in the presentation,
together with new data on the Investigator Global Assessment (IGA)
score.
The primary endpoint of the Phase 1b trial was safety and
tolerability. As previously disclosed, EDP1815 was well tolerated,
with no treatment-related adverse events of moderate or severe
intensity and no serious adverse events. The full results reinforce
the data released on January 20, 2021, demonstrating that treatment
with EDP1815 resulted in clinically meaningful improvements in both
patient- and physician-reported outcomes. At the day 70 follow-up
visit, 31% more EDP1815-treated patients achieved an IGA score of 0
or 1 greater than placebo. At this same time point, 19% more
EDP1815-treated patients reached an IGA score of 0 or 1 with a
two-point improvement from baseline greater than placebo. This, in
addition to the treatment differences seen within the Eczema Area
and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), and
IGA times Body Surface Area (IGA*BSA) clinical endpoints as shown
in the image below, suggests the potential of EDP1815 to be an
effective, safe, well-tolerated, oral treatment for patients with
mild and moderate atopic dermatitis.
Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/ba936911-286c-47fb-956e-411a4bcd10b4
https://www.globenewswire.com/NewsRoom/AttachmentNg/496f2e9d-4400-4f8a-8c95-591de9233f31
“We are pleased to present this complete dataset
from our Phase 1b cohort at the ISAD conference, as it demonstrates
the strong potential of EDP1815 as a therapy for patients with
atopic dermatitis – many of whom are underserved by a lack of
effective, convenient, safe treatment options,” said Douglas
Maslin, M.Phil, M.B. B.Chir, Dermatology and Pharmacology Physician
at Addenbrooke’s Hospital and Immunology Clinical Lead of Evelo.
“We are further encouraged by the IGA data, which showed that
EDP1815 has the potential to provide clinical benefit to patients.
We look forward to initiating our Phase 2 atopic dermatitis trial
in the third quarter of this year in patients with mild, moderate
and severe atopic dermatitis.”
About the EDP1815 Phase 1b Clinical
TrialEDP1815-101 is a double-blind, placebo-controlled
Phase 1b trial designed to evaluate the safety and tolerability of
EDP1815 in healthy volunteers and patients with psoriasis or atopic
dermatitis. The atopic dermatitis cohort enrolled 24 patients
with mild and moderate atopic dermatitis, randomized 2:1 to receive
oral administration of the enteric capsule formulation of EDP1815
or placebo once daily, for 56 days, with follow-up at day 70.
Patients were not allowed to use active topical treatments and were
not required to use emollients. The primary endpoint was safety and
tolerability. Secondary endpoints included a range of established
markers of atopic dermatitis.
About EDP1815EDP1815 is an investigational oral
medicine being developed for the treatment of inflammatory
diseases. It is a non-live pharmaceutical preparation of a
strain of Prevotella histicola, selected for its potential to
provide systemic pharmacological effects after oral administration
with gut-restricted distribution. Being non-live, it has not been
observed to colonize the gut or modify the microbiome.
Preclinically, EDP1815 had anti-inflammatory effects in models that
cover multiple pathways of inflammation, Th1, Th2, and Th17.
Clinical results from five independent cohorts provide evidence
supporting EDP1815’s potential to address Th1, Th2 and
Th17-mediated inflammation.
In the psoriasis cohorts of the Phase 1b clinical trial, EPD1815
was also observed to limit the systemic production of multiple
inflammatory cytokines, including IL-6, IL-8, TNF, and IL-1, which
are well-established mediators of potentially harmful effects in
patients with inflammatory diseases. Preclinical and clinical data
to date showed that EDP1815 achieved this anti-inflammatory
activity without inducing immunosuppression. EDP1815 has been
observed to be well-tolerated in clinical studies to-date.
About Atopic DermatitisAtopic dermatitis, also
known as eczema, is a common chronic inflammatory skin disease that
affects both children and adults, with a prevalence of up to 3-6%
in adults worldwide. It typically presents as a red, intensely
itchy rash that may cause lifelong symptoms. Due to the chronic
nature and frequency of relapses, atopic dermatitis is associated
with a substantial physical and psychosocial burden on patients and
their families. It can also occur alongside other atopic diseases
including food allergy, asthma, and allergic rhinitis, as these
conditions are all associated with an imbalance towards a Th2
inflammatory response – an immune pathway on which EDP1815 has been
shown to have potent pre-clinical, and now also clinical,
activity.
Patients with atopic dermatitis are often treated with topical
medications, which are inconvenient and burdensome in application,
leading to poor adherence and reduced efficacy in a real-world
setting. Beyond topicals, patients have limited treatment options,
especially patients with mild and moderate disease, who represent
80-90% of atopic dermatitis patients worldwide. This group of
patients typically do not have access to high-cost, injectable
antibody therapies or may be uncomfortable with the toxicity
concerns and monitoring requirements of systemic
immunosuppressants. There is a large need across the spectrum of
disease severity, especially for the midline, pre-biologic
patients, for a safe and well-tolerated oral medicine that resolves
the systemic inflammation that drives atopic dermatitis.
About Evelo BiosciencesEvelo Biosciences is a
clinical stage biotechnology company developing orally delivered
medicines that act on SINTAX™, the small intestinal axis, to have
systemic therapeutic effects. SINTAX plays a central role in
governing the immune, metabolic, and neurological systems. The
Company’s first product candidates are pharmaceutical preparations
of single strains of microbes selected for defined pharmacological
properties.Evelo currently has four product candidates in
development: EDP1815, EDP1867, and EDP2939 for the treatment of
inflammatory diseases and EDP1908 for the treatment of cancer.
Evelo is advancing additional product candidates in other disease
areas.
For more information, please
visit www.evelobio.com and engage with Evelo
on LinkedIn.
Forward Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. All statements
contained in this press release that do not relate to matters of
historical fact should be considered forward-looking statements,
including statements concerning the development of EDP1815, the
timing of and plans for clinical trials, and the promise and
potential impact of EDP1815.
These forward-looking statements are based on management's
current expectations. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and
other important factors that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements, including, but not limited to, the
following: the impact of the COVID-19 pandemic on our operations,
including our preclinical studies and clinical trials, and the
continuity of our business; we have incurred significant losses,
are not currently profitable and may never become profitable; our
need for additional funding; our limited operating history; our
unproven approach to therapeutic intervention; the lengthy,
expensive, and uncertain process of clinical drug development,
including potential delays in regulatory approval; our reliance on
third parties and collaborators to expand our microbial library,
conduct our clinical trials, manufacture our product candidates,
and develop and commercialize our product candidates, if approved;
our lack of experience in manufacturing, selling, marketing, and
distributing our product candidates; failure to compete
successfully against other drug companies; protection of our
proprietary technology and the confidentiality of our trade
secrets; potential lawsuits for, or claims of, infringement of
third-party intellectual property or challenges to the ownership of
our intellectual property; our patents being found invalid or
unenforceable; risks associated with international operations; our
ability to retain key personnel and to manage our growth; the
potential volatility of our common stock; our management and
principal stockholders have the ability to control or significantly
influence our business; costs and resources of operating as a
public company; unfavorable or no analyst research or reports; and
securities class action litigation against us.
These and other important factors discussed under the caption
"Risk Factors" in our Annual Report on Form 10-K for the fiscal
year ended December 31, 2020 and our other reports filed with the
SEC could cause actual results to differ materially from those
indicated by the forward-looking statements made in this press
release. Any such forward-looking statements represent management's
estimates as of the date of this press release. While we may elect
to update such forward-looking statements at some point in the
future, except as required by law, we disclaim any obligation to do
so, even if subsequent events cause our views to change. These
forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of
this press release.
ContactJessica Cotrone,
978-760-5622jcotrone@evelobio.com
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