Prometheus Biosciences Provides Corporate Updates at the 40th Annual J.P. Morgan Healthcare Conference
13 January 2022 - 12:30AM
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, today announced that management will
discuss the following updates at the 40th Annual J.P. Morgan
Healthcare Conference.
Fast Track DesignationThe US FDA has granted
Fast Track Designation for Prometheus’ lead therapeutic candidate,
PRA023, for the treatment of Systemic Sclerosis-Associated
Interstitial Lung Disease (SSc-ILD).
"We are pleased to have received Fast Track Designation for
PRA023 in SSc-ILD as it clearly demonstrates that the FDA
recognizes the importance of expeditiously evaluating potential
treatments for SSc-ILD and the need for improved clinical outcomes
for patients with this debilitating disease," said Chairman and
CEO, Mark McKenna. "Based on our positive topline Phase 1 results,
and receipt of Fast Track Designation, we believe PRA023 is
well-positioned to deliver on our mission to have a broad impact on
patients with SSc-ILD. If successful in Phase 2 clinical trials,
Prometheus would seek Breakthrough Therapy Designation in SSc-ILD
given that there are currently no approved disease modifying
therapies."
Fast Track Designation aims to facilitate the development and
accelerate the review of new therapeutics that are intended to
treat serious or life-threatening conditions and potentially
address an unmet medical need. Drugs that are granted this
designation are given the opportunity for more frequent
interactions with the FDA, as well as potential pathways for
expedited approval.
The Company plans to initiate patient enrollment in
ATHENA-SSc-ILD in the first quarter of 2022.
ATHENA-SSc-ILD is a placebo-controlled Phase 2 trial of PRA023 in
SSc-ILD, with anticipated enrollment of 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 annual rate of change in
forced vital capacity (FVC) at 50 weeks. Secondary endpoints will
be the 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.
New Patent GrantedThe U.S. Patent and Trademark
Office (USPTO) has granted a U.S. patent to Prometheus covering its
companion diagnostic technology. US Patent No. 11,136,386 B2
covers claims directed to methods of treating Crohn’s disease or
ulcerative colitis by administering inhibitors of tumor necrosis
factor-like cytokine 1A (TL1A) to patients selected by a defined
companion diagnostic test. This newly granted patent reinforces
Prometheus’ precision approach and extends the Company’s patent
coverage of its PRA023 companion diagnostic into 2040.
Prometheus’ companion diagnostic is being utilized across its
Phase 2 studies to identify patients that we believe may be more
likely to respond to PRA023. The companion diagnostic was developed
through the Company’s Prometheus360TM platform, which combines one
of the world’s largest GI bioinformatics databases with a
custom-built suite of data science tools, designed to guide drug
discovery and enable the matching of drug mechanism to patient
biology, and has been validated in more than 400 IBD patients.
Presentation at the 40th Annual J.P. Morgan Healthcare
ConferencePrometheus will webcast its corporate
presentation from the 40th Annual J.P. Morgan Healthcare Conference
today, January 12, 2022 at 1:30 PM ET. The presentation will be
webcast live on the Events & Webcasts page on the Investor
section of Prometheus’ website and will be available for 30 days
following the presentation. It is recommended that users connect to
Prometheus’ website several minutes prior to the start of the
webcast to ensure a timely connection.
About Prometheus BiosciencesPrometheus
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.
The Company’s lead candidate, PRA023, is an IgG1 humanized
monoclonal antibody (mAb) in development for the treatment of
immune-mediated diseases, including ulcerative colitis (UC),
Crohn’s disease (CD), and a recently announced third indication,
systemic sclerosis-associated interstitial lung disease (SSc-ILD).
The Company is currently conducting a Phase 2 trial in UC patients
and a Phase 2a trial in CD patients, each utilizing a
genetics-based companion diagnostic designed to identify patients
who are predisposed to increased expression of TL1A and therefore
potentially more likely to respond to PRA023. The company also
plans to initiate a Phase 2 clinical trial for PRA023 in SSc-ILD in
the first quarter of 2022.
Forward Looking StatementsPrometheus 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 our current beliefs and
expectations. Such forward-looking statements include, but are not
limited to statements regarding the potential benefits of Fast
Track Designation, the timing of the initiation and enrollment of
Prometheus’ planned Phase 2 clinical trial for PRA023 in SSc-ILD,
the potential benefits of PRA023 for patients with SSc-ILD,
Prometheus’ plans to use its PRA023 companion diagnostic in future
clinical trials, the potential benefits of Prometheus360, and the
anticipated term of IP protection for PRA023 and its companion
diagnostic. 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 preclinical studies and future
clinical trials, including due to the COVID-19 pandemic;
Prometheus’ dependence on third parties in connection with product
manufacturing, research and preclinical and clinical testing, and
potential supply chain disruptions related to the COVID-19
pandemic; Prometheus’ ability to develop, validate and
commercialize a companion diagnostic for PRA023 in multiple
indications; Prometheus may not realize the potential benefits of
Fast Track Designation; and other risks described in our prior
press releases and filings with the Securities and Exchange
Commission (SEC), including under the heading “Risk Factors”
in our 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 we undertake 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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