Prometheus Biosciences Initiates Third Phase 2 Study of PRA023 for Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)
March 30 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 it has enrolled its first patient in the
ATHENA-SSc-ILD trial, a placebo-controlled and statistically
powered Phase 2 study of PRA023 in SSc-ILD. The Company announced
in January 2021 that PRA023 received Fast Track Designation from
the US Food and Drug Administration for the treatment of SSc-ILD.
“PRA023, our anti-TL1A antibody, has shown the
potential to be a differentiated, best-in-class precision therapy
for multiple immune-mediated diseases and we now have three Phase 2
trials underway, demonstrating PRA023’s pipeline-in-a-product
opportunity,” said Mark McKenna, Chairman and CEO of Prometheus.
“Prometheus’ initiation of ATHENA-SSc-ILD exemplifies our team’s
strong execution, marking the first indication of PRA023 outside of
IBD.”
Systemic Sclerosis (SSc) is a rare autoimmune
disorder characterized by progressive fibrosis of the skin and
internal organs thought to result from inflammation and chronic
immune activation. Lung involvement (SSc-ILD) is the leading cause
of morbidity and mortality for individuals with the disorder.
SSc-ILD has been largely irreversible with current therapeutic
strategies focused on slowing progression of the disorder.
“We believe PRA023’s dual anti-fibrotic and
anti-inflammatory mechanism of action is well-suited to address the
underlying disease pathophysiology of SSc-ILD, where no disease
modifying therapies currently exist,” said Allison Luo, M.D., Chief
Medical Officer of Prometheus. “The initiation of the
ATHENA-SSc-ILD study is an important milestone for the Company and
for patients who are suffering from this rare
disorder.”
About the ATHENA-SSc-ILD Study
ATHENA-SSc-ILD is a placebo-controlled Phase 2 trial of PRA023
in SSc-ILD, enrolling approximately 100 patients who will be
randomized 1:1 to either the active or placebo arm. The primary
endpoint of the trial will be the change in forced vital capacity
(FVC) at 50 weeks. Secondary endpoints will be change in
quantitative interstitial lung disease by centrally-read
high-resolution computed tomography (HRCT) and improvement in the
American College of Rheumatology Combined Response Index in Diffuse
SSc (ACR-CRISS) score. We also plan to evaluate a variety of
patient reported outcomes for dyspnea, disability, effects of skin
thickening, and bowel function. ATHENA-SSc-ILD will also assess the
performance of our companion diagnostic candidate for PRA023.
Upcoming 2022 Milestones and Events
- Update on UC and CD Phase 2
enrollment planned in 2Q
- Investigational Device Exemption
(IDE) submission of the companion diagnostic for PRA023 planned in
3Q
- IND submission for PR600 planned for
3Q
- Topline results from the ARTEMIS-UC
Phase 2 study expected in 4Q
- Topline results from APOLLO-CD Phase
2a study expected in 4Q
About PRA023: Pipeline in a Product
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 immune-mediated diseases including
Ulcerative colitis (UC), Crohn’s disease (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, a Phase 2a trial in CD
patients, and a Phase 2 clinical trial in SSc-ILD, 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 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 potential therapeutic benefits of PRA023 and its ability to
address a number of immune-mediated diseases; the design of
Prometheus’ Phase 2 clinical trial in SSc-ILD; Prometheus’ timing
to provide an update regarding enrollment in its ongoing Phase 2
clinical trial in UC and its ongoing Phase 2a clinical trial in CD
as well as the timing to announce topline data from these studies;
timing to submit an IDE for the its companion diagnostic candidate
for PRA023; and the timing to submit an IND for Prometheus’ PR600
therapeutic candidate. The inclusion of forward-looking statements
should not be regarded as a representation by Prometheus that any
of its 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, 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 companion diagnostics for
its therapeutic product candidates; the success of clinical trials
and preclinical studies for the company’s therapeutic product
candidates and its companion diagnostic 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 its current and any
future collaborations; regulatory developments in the United
States and foreign countries; Prometheus’ ability to obtain
and maintain intellectual property protection for its product
candidates and maintain its rights under intellectual property
licenses; Prometheus’ ability to maintain undisrupted business
operations due to the COVID-19 pandemic, war and other
international political and economic risks, in foreign countries,
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 annual
report on Form 10-K 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.
Prometheus Biosciences Contact:Noel KurdiVP
Investor Relations and Communications(646)
241-4400nkurdi@prometheusbiosciences.com
Media contact:Juniper PointAmy Conrad(858)
914-1962amy@juniper-point.com
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