Prometheus Biosciences Provides Enrollment Update in APOLLO-CD and ARTEMIS-UC Global Phase 2 Studies
June 08 2022 - 8:00AM
Prometheus Biosciences, Inc. (Nasdaq: RXDX), a biotechnology
company pioneering a precision medicine approach for the discovery,
development, and commercialization of novel therapeutic and
companion diagnostic products for the treatment of immune-mediated
diseases, today announced an enrollment update on the
APOLLO-CD and ARTEMIS-UC trials. The company has completed
enrollment for APOLLO-CD, a global Phase 2a study of PRA023 in
Crohn’s Disease (CD) and enrollment remains on track in the Phase 2
study of PRA023 for ARTEMIS-UC in ulcerative colitis (UC) with
enrollment completion of cohort 1 expected in the third quarter of
this year. Topline results from both APOLLO-CD and ARTEMIS-UC are
expected in the fourth quarter of this year.
“Completing enrollment of APOLLO-CD is a major milestone for the
trial and an important achievement for Prometheus given the
expeditious speed in the execution of our trials,” said Mark
McKenna, Chairman and Chief Executive Officer of Prometheus. “We
believe that the strong interest we have seen from investigators
and the accelerated pace of trial enrollment demonstrates there is
a clear and compelling need to address both inflammation and
fibrosis in IBD and we look forward to reading out our topline
results later this year.”
“APOLLO-CD enrollment completion is an important landmark for
both Prometheus and for people living with Crohn’s disease. We are
also nearing completion of enrollment for the initial cohort in our
ARTEMIS-UC study and expect our Enroll360TM platform to expedite
enrollment in the expansion cohort in this study which will
evaluate the effectiveness of our companion diagnostic,” said
Allison Luo, M.D., Chief Medical Officer of Prometheus. “We
continue to advance a very broad, global development program for
PRA023, evaluating its efficacy and safety in three immune-mediated
diseases across three Phase 2 studies, while continuing to meet
aggressive timelines to swiftly bring this promising therapy to
patients.”
With Enroll360TM, Prometheus has been building a global network
of trial-ready sites where over 2,500 patients have already been
genetically profiled and clinically characterized to determine
their eligibility for Prometheus’ current and future clinical
trials. Prometheus plans to utilize this patient recruitment
platform to accelerate patient identification and increase the rate
of enrollment for the company’s biomarker-guided clinical trials,
starting with the expansion cohort of the ARTEMIS-UC Phase 2
study.
The company also remains on track for implementing its
subcutaneous formulation for registrational studies in UC and CD,
with an industry-leading subcutaneous formulation of 200 mg/ml.
This will potentially eliminate the conventional need to bridge
with a pre-filled syringe. In the first quarter of this year,
Prometheus initiated a subcutaneous bridging study by dosing
Caucasian normal healthy volunteers with PRA023 to assess the
bioavailability of the subcutaneous formulation. In addition,
Prometheus also initiated dosing of healthy volunteers of Japanese
descent with PRA023 as part of the bridging study to assess safety,
tolerability, and pharmacokinetics.
Webcast Information
Prometheus management will be presenting at the Jefferies
Healthcare Conference today at 10:00am ET. A live and archived
webcast of the presentation will be available via the Events &
Webcasts page on the Investor section of the Prometheus Biosciences
website.
About PRA023: Pipeline in a Product
PRA023 is an IgG1 humanized monoclonal antibody that has been
shown to block tumor necrosis factor (TNF)-like ligand 1A (TL1A).
PRA023 binds both soluble and membrane-associated human TL1A with
high affinity and specificity and has the potential to
substantially improve outcomes for moderate-to-severe IBD patients
predisposed to increased TL1A expression. Prometheus is developing
PRA023 for the treatment of immune-mediated diseases including UC,
CD, and systemic sclerosis-associated interstitial lung disease
(SSc-ILD).
The Company is currently conducting three Phase 2 studies of
PRA023: a Phase 2 trial in UC patients, ARTEMIS-UC, a Phase 2a
trial in CD patients, APOLLO-CD, and a Phase 2 clinical trial in
SSc-ILD, ATHENA-SSc, each utilizing a genetic-based companion
diagnostic candidate designed to identify patients who are
predisposed to increased expression of TL1A and therefore
potentially more likely to respond to PRA023.
Prometheus’ Phase 2 ARTEMIS-UC clinical trial is currently
enrolling patients with moderate-to-severely active UC who have
failed conventional therapy, including biologics. The trial is a
12-week, double-blind, placebo-controlled, randomized study to
evaluate the efficacy and safety of PRA023 in patients with UC. The
initial cohort is statistically powered to evaluate the efficacy of
PRA023 in 120 patients with UC and topline results are expected in
4Q 2022. The expansion cohort is statistically powered to further
evaluate the effectiveness of the company’s companion diagnostic in
approximately 40 additional patients with UC who have also been
classified as positive by the companion diagnostic.
Prometheus’ Phase 2a APOLLO-CD clinical trial is a 12-week open
label study that has completed enrollment in 50 patients with
moderate-to-severely active CD with endoscopically active disease
who have failed conventional therapy, including biologics. The
study will assess the efficacy of PRA023 and the effectiveness of
the company’s companion diagnostic in patients with CD. Topline
results for the Phase 2a APOLLO-CD trial are expected in 4Q
2022.
About Prometheus Biosciences
Prometheus Biosciences, Inc. is a clinical-stage biotechnology
company pioneering a precision medicine approach for the discovery,
development, and commercialization of novel therapeutic and
companion diagnostic products for the treatment of immune-mediated
diseases. The company’s precision medicine platform,
Prometheus360TM, combines proprietary machine learning-based
analytical approaches with one of the world’s largest
gastrointestinal bioinformatics databases to identify novel
therapeutic targets and develop therapeutic candidates to engage
those targets.
Forward Looking Statements
Prometheus cautions readers that statements contained in this
press release regarding matters that are not historical facts are
forward-looking statements. These statements are based on the
company’s current beliefs and expectations. Such forward-looking
statements include, but are not limited to statements regarding:
the timing of enrollment and topline results of Prometheus’
APOLLO-CD and ARTEMIS-UC trials; Prometheus’ Enroll360TM program
and the company’s ability to accelerate enrollment in its planned
and other future clinical trials; and the ability of Prometheus’
genetic-based companion diagnostic candidate to classify patients
who are predisposed to increased expression of TL1A or more likely
to respond to PRA023. The inclusion of forward-looking statements
should not be regarded as a representation by Prometheus that any
of our plans will be achieved. Actual results may differ from those
set forth in this press release due to the risks and uncertainties
inherent in our business, including, without limitation:
Prometheus’ approach to the discovery and development of precision
medicines based on Prometheus360 TM is unproven; potential delays
in the commencement, enrollment and completion of clinical trials
and preclinical studies; the Enroll360 TM program may not increase
the efficiency or enrollment rates in clinical trials; Prometheus’
dependence on third parties in connection with product
manufacturing, research and preclinical and clinical testing;
Prometheus’ ability to develop companion diagnostics for our
therapeutic product candidates; unexpected adverse side effects or
inadequate efficacy of our product candidates that may limit their
development, regulatory approval and/or commercialization, or may
result in recalls or product liability claims; the results of
preclinical studies and early clinical trials are not necessarily
predictive of future results; Prometheus may not realize any
benefits from our current and any future collaborations; regulatory
developments in the United States and foreign countries;
Prometheus’ ability to obtain and maintain intellectual property
protection for our product candidates and maintain our rights under
intellectual property licenses; Prometheus’ ability to maintain
undisrupted business operations due to the COVID-19 pandemic,
including delaying or otherwise disrupting its clinical trials,
manufacturing and supply chain; and other risks described in the
company’s prior press releases and filings with the Securities and
Exchange Commission (SEC), including under the heading “Risk
Factors” in our Form 10-K filed with the SEC on March 9, 2022 and
any subsequent filings with the SEC. You are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date hereof, and except as required by applicable
law, we do not plan to publicly update or revise any
forward-looking statements contained herein, whether as a result of
any new information, future events, changed circumstances or
otherwise. All forward-looking statements are qualified in their
entirety by this cautionary statement, which is made under the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995.
Contacts:Noel KurdiVP Investor Relations and
Communications(646) 241-4400nkurdi@prometheusbiosciences.com
Media contact:Juniper PointAmy Conrad(858)
914-1962media@prometheusbiosciences.com
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