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Prometheus Biosciences Receives FDA Clearance of IND Application for its Second Precision Program, PRA052

- PRA052 is a monoclonal antibody blocking CD30 ligand that has a pleiotropic effect on both innate and adaptive immunity and targets a pathway that is distinct from TNF -

- PRA052 is the second clinical candidate identified using the Prometheus360™ platform with one of the strongest genetic associations to IBD and is linked to a broad range of immune-mediated diseases -

- Initiation of Phase 1 study of PRA052 expected in 4Q 2022 -

SAN DIEGO, Oct. 03, 2022 (GLOBE NEWSWIRE) -- 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 the U.S. Food and Drug Administration (FDA) cleared the company to proceed with a clinical trial under its Investigational New Drug Application (IND) for PRA052 in ulcerative colitis. Initiation of a Phase 1 SAD/MAD study for PRA052 in normal healthy volunteers is expected to commence in the fourth quarter of this year.

PRA052 is a first-in-class monoclonal antibody blocking CD30 ligand with ulcerative colitis as the initial indication. CD30L is a costimulatory molecule that has been implicated in inflammatory bowel disease (IBD) by genetic, preclinical, and human translational data.  The broad role of the CD30L pathway in immune-mediated disease makes PRA052 a compelling candidate for a variety of diseases beyond IBD.   For more information on CD30L and Prometheus’ PRA052 program, view the R&D Day webcast here.

“The FDA’s clearance of our IND for PRA052 is an important milestone in our pursuit of bringing precision medicine to patients by flexing the power of our Prometheus360TM platform to discover these therapeutic candidates,” said Mark McKenna, Chairman and CEO. “I applaud our team that has driven PRA052 from discovery to the clinic, leveraging our cutting-edge platform and implementing a precision-based approach with an aim to inform future patient selection and increase efficacy in patients.”

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.

The Company’s lead candidate, PRA023, is an IgG1 humanized monoclonal antibody that has been shown to block tumor necrosis factor (TNF)-like ligand 1A (TL1A) and is in development for the treatment of immune-mediated diseases. The Company is currently conducting three Phase 2 studies of PRA023: a Phase 2 trial in UC patients, ARTEMIS-UC, a Phase 2a trial in CD patients, APOLLO-CD, and a Phase 2 trial in SSc-ILD, ATHENA-SSc-ILD, each utilizing a genetic-based companion diagnostic candidate designed to identify patients who are predisposed to increased expression of TL1A and therefore potentially more likely to respond to PRA023.

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 1 clinical trial for PRA052 in normal healthy volunteers; planned and potential indications for PRA052; and Prometheus’ Prometheus360TM platform and its ability to discover novel therapeutic candidates, inform patient selection and increase efficacy. 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; regulatory developments in the United States and foreign countries, including with respect to INDs and similar foreign regulatory filings and the proposed design of future clinical trials; 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 or other geopolitical events, 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.

Noel Kurdi
VP Investor Relations and Communications
(646) 241-4400

Media contact:
Juniper Point
Amy Conrad
(858) 914-1962

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