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, CA, USA I October 03, 2022 I 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.

SOURCE: Prometheus Biosciences

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