Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage
biotechnology company developing SINTAX™ medicines as a new
modality of orally delivered treatments for inflammatory disease,
today presented a late-breaking oral abstract on data from a Phase
2 trial of EDP1815 in psoriasis at the 2022 American Academy of
Dermatology (AAD) Annual Meeting, being held March 25-29 in Boston,
Massachusetts.
“We are proud to join the dermatology community at AAD to share
the latest data from the clinical development of EDP1815 in
psoriasis. The data being shared demonstrate the potential of
Evelo's SINTAX platform, and support progression towards
registration trials for EDP1815,” said Douglas Maslin, M.Phil, M.B.
B.Chir, Dermatology and Pharmacology Physician at Addenbrooke’s
Hospital and Clinical Lead, Late Stage Development of Evelo. “These
data, combined with positive feedback from patients and physicians,
as highlighted by our recent KOL event, suggest the potential
profile of EDP1815 as a safe, effective, oral, and well-tolerated
therapy for psoriasis, which could address a significant unmet need
for patients across all stages of disease.”
Late-Breaking Oral Presentation at AAD 2022
- A phase 2 study investigating the effect of EDP1815, an
orally-delivered, anti-inflammatory, gut-restricted commensal
microbe in the treatment of mild and moderate plaque
psoriasis, D. Maslin, Y. Mihaylov, D. Macaro, N.
Carpenter, G. Mehraei, M. Bodmer, J. Zung, M. Plinio, D. McHale, B.
Ehst
- EDP1815-201 was a Phase 2 clinical trial evaluating EDP1815
versus placebo for the treatment of mild and moderate psoriasis,
comprised of a Part A, where patients received either EDP1815 or
placebo for 16 weeks, and a Part B, where patients were followed
for up to 24 weeks after they had stopped receiving EDP1815 or
placebo.
- EDP1815 was well tolerated with safety data comparable to
placebo: no drug-related serious adverse events, and no meaningful
difference in infections or gastrointestinal events observed.
- During the 16-week dosing period, the primary endpoint analysis
demonstrated EDP1815 was superior to placebo with 80-90%
probability across each cohort. Each cohort showed increased
Psoriasis Area and Severity Index (PASI) score responses, as
measured by the proportion of patients achieving at least a 50%
improvement in PASI (PASI-50) from baseline at week 16:
statistically significant (p<0.05) over placebo in cohorts 1 and
2. A post-hoc analysis comparing PGA 0/1 response rate showed
statistical significance with a rate of 20.2% compared to 9.1% in
placebo (p=0.048).
- In Part B of the trial, patients were followed for up to 24
weeks after they had stopped receiving EDP1815 or placebo. During
the post-treatment period, durable and deepening clinical responses
were observed, with no flare or rebound of psoriasis. There were 83
patients who had received EDP1815 in Part A who entered Part B.
Thirty of these 83 patients achieved a PASI-50 or greater reduction
at the end of Part A. Eighteen of the 30 patients remained at
PASI-50 or greater at the end of Part B. Ten of these 30 patients
achieved a PASI-75 or greater at the end of Part A and 5 of them
remained at PASI-75 or greater at the end of Part B.
- These results provide the first demonstration in a Phase 2
trial of the safety and efficacy of an orally-administered,
gut-restricted SINTAX medicine, proving the ability to harness
SINTAX to treat systemic inflammation, and paving the way for a new
modality of anti-inflammatory medicines.
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 multiple independent cohorts provide evidence
supporting EDP1815’s potential to address Th1, Th2 and
Th17-mediated inflammation.
About EDP1815-201EDP1815-201 was a multicenter,
randomized, double-blind, placebo-controlled, parallel-cohort,
dose-ranging trial in adult patients with mild and moderate
psoriasis. The study included a Part A (treatment phase) and Part B
(extended follow-up phase, off-treatment).
In Part A of the trial, 249 patients were randomized in a 1:1:1
ratio to one of three parallel cohorts: 1 capsule, 4 capsules or 10
capsules. They were then randomized in a 2:1 ratio to active or
placebo prior to starting dosing. Trial medication was taken once
daily for 16 weeks, and patients were followed for 4 weeks after
treatment completion to week 20. In the trial, the PASI scores were
assessed by both mean changes from baseline and responder rates.
The primary endpoint was the mean percentage change in PASI between
treatment and placebo. Secondary endpoints included the proportion
of trial participants who achieve a PASI-50 response or greater.
The 16-week primary endpoint gave probabilities that EDP1815 was
superior to placebo ranging from 80% to 90% across the prespecified
analyses and cohorts. 25% to 32% of patients across the three
cohorts who were treated with EDP1815 achieved a PASI-50 at week 16
compared to 12% on placebo.
All patients had the option to enter Part B of the trial. The
objective of Part B was to assess durability of treatment response
and incidence of rebound (e.g., increase in PASI score to 125% of
baseline value or above, or onset of new pustular erythrodermic
psoriasis within 3 months of cessation of dosing) following
cessation of dosing. Patients in Part B were assessed during
follow-up visits at weeks 24 and 28. Only patients who had achieved
a PASI-50 or greater at week 16 were also evaluated at week 40.
Patients were not permitted to start other psoriasis treatments or
trials during Part B.About PsoriasisPsoriasis is a
common chronic immune-mediated inflammatory skin disease, affecting
up to 3% of the population worldwide. The disease is driven by
Th17-inflammation, which results in the formation of thick red
plaques with scaling. Psoriatic lesions can appear anywhere on the
body but are most often seen on the knees, elbows, scalp, and
lumbar area. In addition to the skin lesions, there are systemic
manifestations of the disease including arthritis and fatigue, and
a strong association with depression and metabolic syndrome.
Patients with mild and moderate psoriasis are underserved by
current treatments. Topical therapies do not control systemic
inflammation, have low rates of compliance, and in the case of
topical steroids are not recommended for long-term use. The
majority of novel therapies, including injectable high-cost
biologics, are only approved for patients with moderate and severe
disease. Even in the severe patient population, the majority of
eligible patients do not receive biologics, instead opting for
topical therapies or oral systemic therapies, which are associated
with tolerability issues and/or with monitoring requirements tied
to safety concerns.
About Evelo BiosciencesEvelo
Biosciences is a clinical stage biotechnology company
developing orally delivered product candidates that are designed to
act on the small intestinal axis, SINTAX™, with 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 their potential to offer defined
pharmacological properties. Evelo’s therapies have the potential to
be effective, safe, and affordable medicines to improve the lives
of people with a broad range of inflammatory diseases.
Evelo currently has three product candidates in development for
inflammatory diseases: EDP1815, EDP1867, and EDP2939. 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 and our
other product candidates, and the promise and potential impact of
our product candidates.
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, 2021, 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.
ContactsInvestors:Kendra Sweeney,
239-877-7474ksweeney@evelobio.com
Media:Jessica Cotrone,
978-760-5622jcotrone@evelobio.com
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