Prometheus Biosciences Announces Initiation of Global Phase 2 Clinical Trial of PRA023 in Moderate-to-Severe Ulcerative Colit...
July 19 2021 - 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, starting first with inflammatory bowel disease (IBD),
today announced the initiation of the Phase 2 ARTEMIS-UC clinical
trial evaluating PRA023 for moderate-to-severe ulcerative colitis
(UC), with first patient enrollment. The study is
placebo-controlled and statistically powered to evaluate the
efficacy and safety of PRA023 in UC patients. The
company plans to provide more details of the Phase 2 ARTEMIS-UC
study at R&D Day on July 28th.
“The majority of patients with UC cannot achieve clinical
remission through the use of currently available therapies,” said
Allison Luo, MD, Chief Medical Officer of Prometheus. “This gives
Prometheus compelling motivation to rapidly advance PRA023,
addressing both inflammation and fibrosis and leading the precision
medicine approach in the IBD space, starting first with the
ARTEMIS-UC study.”
Prometheus has recently completed the dosing phase of the Phase
1a clinical trial of PRA023, a single center, double-blind,
placebo-controlled trial to determine the safety, tolerability,
pharmacokinetics, and pharmacodynamics of PRA023 in normal healthy
volunteers. Safety and tolerability observed to date supports the
initiation of a Phase 2 trial. Final Phase 1a results of PRA023 in
UC and CD are expected in the fourth quarter of 2021. Further
details will be provided at the company’s R&D Day on July 28,
2021. Register here: Prometheus R&D Day
About PRA023
PRA023 is an IgG1 humanized monoclonal antibody (mAb) 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 the two most common forms of
IBD, Ulcerative Colitis (UC) and Crohn’s Disease (CD). The Company
has initiated enrollment in a Phase 2 trial in UC patients. The
Company is also developing a genetic-based companion diagnostic to
identify patients who are predisposed to increased expression of
TL1A and therefore potentially more likely to respond to
PRA023.
About Prometheus Biosciences
Prometheus Biosciences, Inc. is a biotechnology company
pioneering a precision medicine approach for the discovery,
development, and commercialization of novel therapeutic and
companion diagnostic products for the treatment and diagnosis of
immune-mediated diseases, starting first with IBD. The
Company’s precision medicine platform, Prometheus360™,
combines proprietary bioinformatics discovery methods with one of
the world’s largest gastrointestinal bioinformatics databases to
identify novel therapeutic targets and develop therapeutic
candidates to engage those targets. Prometheus is
headquartered in San Diego, CA.
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 commencement of Prometheus’ Phase 2 clinical trial in
UC and its Phase 2a clinical trial in CD; Prometheus’ Enroll360™
program and the company’s ability to accelerate enrollment in its
planned and other future clinical trials; and the timing of
Prometheus obtaining the final study results from its Phase 1a
clinical trial of 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™ is unproven;
potential delays in the commencement, enrollment and completion of
clinical trials and preclinical studies; 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 Prometheus’ most recent quarterly report on Form 10-Q
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 Prometheus undertakes no
obligation to update such statements to reflect events that occur
or circumstances that exist after the date hereof. 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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