Prometheus Biosciences Announces Initiation of APOLLO-CD Phase 2a Clinical Trial of PRA023 in Moderate-to-Severe Crohn’s Disease
August 02 2021 - 08:00AM
Prometheus Biosciences, Inc. (Nasdaq: RXDX), 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, starting first with inflammatory bowel
disease (IBD), today announced the initiation of the APOLLO-CD
Phase 2a clinical trial evaluating PRA023 for moderate-to-severe
Crohn’s disease (CD), with first patient enrollment.
“We are excited to advance PRA023 into the APOLLO-CD Phase 2a
study as we believe its novel mechanism of action, designed to
address both inflammation and fibrosis, can have a significant
impact on patients suffering with Crohn’s disease,” said Allison
Luo, MD, Chief Medical Officer of Prometheus. “We believe PRA023
has the potential to address the highest unmet need of
fibrostenotic disease in this patient population.”
The APOLLO-CD Phase 2a trial is an open-label study designed to
evaluate the proof-of-concept efficacy and safety of PRA023 in
moderate-to-severe Crohn’s disease with centrally read endoscopy as
the primary endpoint. Dosing regimen of the 50 subjects in the
study will consist of 1,000 mg on day 1, followed by 500 mg on
weeks 2, 6, and 10 for a total of 12 weeks on therapy. The primary
endpoint at week 12 will evaluate the proportion of patients
achieving endoscopic improvement as defined by 50% decrease in
Simple Endoscopic Score for Crohn’s Disease (SES-CD), which
assesses the size of mucosal ulcers, the ulcerated surface, the
endoscopic extension and the presence of stenosis. Each subject
will also be assessed for the status of companion diagnostic (CDx)
assay we are developing and subgroup analyses for all endpoints
will be conducted based on CDx results.
“Clinicians and patients are excited about Prometheus’ precision
approach coupled with the anti-fibrotic mechanistic approach of the
anti-TL1A therapy,” said Dr. G. Aaron Duvall, gastroenterologist
and investigator at Tyler Research Institute. “I am thrilled to
participate in both the ulcerative colitis and Crohn’s disease
studies to help bring this novel therapeutic approach, with the use
of a companion diagnostic, to patients.”
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 this Phase 2a trial. Final Phase 1a
results of PRA023 are expected in the fourth quarter of 2021.
Separately, Prometheus recently initiated and dosed the first
patient in the ARTEMIS-UC Phase 2 trial to evaluate the efficacy
and safety of PRA023 in moderate-to-severe ulcerative colitis (UC)
patients.
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, UC and CD. The Company has initiated enrollment in a Phase 2
trial in UC patients and a Phase 2a trial in CD patients, each
utilizing a genetic-based companion diagnostic designed 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 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 and diagnosis of
immune-mediated diseases, starting first with IBD. The
Company’s precision medicine platform, Prometheus360TM,
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 potential of PRA023 and a companion diagnostic to address a
high unmet need for patients; and the timing of Prometheus
reporting 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
Prometheus360TM is unproven, and the Company may not be able to
develop any therapeutics or companion diagnostic products of
commercial value; 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 a companion diagnostic for PRA023;
the success of clinical trials and preclinical studies for its
product candidates and companion diagnostic; 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; 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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