Prometheus Biosciences and Dr. Falk Pharma Advance PR600 and Trigger Final Preclinical Milestone Payment
January 03 2022 - 8:00AM
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, today announced it has received its final
preclinical milestone payment from Dr. Falk Pharma GmbH under its
collaboration agreement to develop and commercialize Prometheus’
second program, PR600. The milestone was based on Prometheus’
development of a proprietary companion diagnostic candidate for the
PR600 program.
“Dr. Falk Pharma has been an excellent partner for us on our
PR600 program,” said Mark McKenna, Prometheus’ Chairman and Chief
Executive Officer. “We are excited to initiate this program with
our proprietary companion diagnostic candidate in the clinic in
2022 and explore its utility in IBD and potentially other
immune-mediated indications.”
“It is our goal to find solutions that will ultimately help the
millions of people living with inflammatory bowel disease and the
Prometheus team has been a strong partner with a differentiated
approach that we believe will help us achieve that goal,” said
Roland Greinwald, Ph.D., Managing Director Medicine and
Pharmaceutics, Dr. Falk Pharma. “We are excited to support this
clinical candidate now coupled with Prometheus’ companion
diagnostic technology with the hope that it will enable our
partnership to bring precision treatment to patients suffering from
IBD.”
Prometheus previously disclosed the selection of the clinical
candidate and the initiation of IND-enabling studies for the PR600
program, which targets a member of the TNF super-family with a key
impact on the function of memory T cells and T follicular helper
cells in immune-mediated diseases. The company has since developed
a companion diagnostic candidate designed to select for patients
with biomarkers that may enable a greater clinical response to
PR600 than patients who do not have the relevant biomarkers.
Prometheus expects to submit an Investigational New Drug
Application for PR600 in the third quarter of 2022.
Under the collaboration agreement, which was executed in July
2020, Prometheus and Dr. Falk Pharma will share responsibility for
the global development of PR600, with Dr. Falk Pharma contributing
a portion of the external development costs associated with PR600
and its companion diagnostic. As part of the collaboration, Dr.
Falk Pharma will be responsible for regulatory approvals and
commercialization of any products in the European Union, United
Kingdom, Switzerland, the countries of the European Economic Area
(excluding Malta and the Republic of Cyprus), Australia and New
Zealand. Prometheus will be responsible for regulatory approvals
and commercialization in all other areas of the world, including
the United States.
“The progress we have made in the PR600 program is a testament
to the work executed by our world-class R&D group with the aid
of our proprietary Prometheus360™ platform,” said Olivier Laurent,
Ph.D., Chief Scientific Officer of Prometheus. “We believe that
Prometheus360™ gives us the ability to continuously identify novel
targets, as well as matching companion diagnostic assays, and helps
accelerate our timelines from early discovery and development into
the clinic.”
About Dr. Falk Pharma GmbH
Dr. Falk Pharma GmbH has been developing and marketing
innovative medicines to treat a wide range of gastrointestinal
disorders like inflammatory bowel disease or eosinophilic
esophagitis as well as hepatobiliary disorders such as primary
biliary cholangitis for over 60 years. As the international experts
in digestive and metabolic medicine, the company brings together
physicians, scientists, and patients to devise new and powerful
approaches to patient care. Dr. Falk Pharma engages in pre-clinical
and clinical stage research that aims to meaningfully improve
therapeutic practice as well as patient health and well-being. A
family-owned business with a global presence, Dr. Falk Pharma has
ten affiliates in Europe and Australia and is continuously growing.
The company has its headquarters and R&D facilities in
Freiburg, Germany, its pharmaceutical products are manufactured in
Europe, mainly at sites in Germany, France and Switzerland.
Further information on Dr. Falk Pharma can be found online:
https://drfalkpharma.com
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,
Prometheus360™, 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 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 Prometheus’ expected timing to file
an IND for PR600, Prometheus’ plans to advance the development of
its companion diagnostic candidate for the PR600 program and to use
such companion diagnostic candidate in planned clinical trials for
PR600, the potential cost savings under the collaboration with Dr.
Falk, Prometheus’ plans to explore PR600 in other indications
beyond IBD, and the potential to identify novel targets and
companion diagnostic assays and to accelerate clinical development
using Prometheus360. 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 a companion diagnostic for
PR600; Prometheus may not realize any benefits from our
collaboration with Dr. Falk; 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
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