Prometheus Biosciences Advance PR600

Prometheus Biosciences Inc., 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, announced today that it has received its final preclinical milestone payment from Dr. Falk Pharma GmbH under the terms of its collaboration agreement to develop and commercialise  second programme, PR600.

Prometheus achieved this milestone by developing a proprietary companion diagnostic candidate for the PR600 programme. The PR600 programme, which targets a member of the TNF superfamily with a critical impact on the function of memory T cells and T follicular helper cells in immune-mediated illnesses, has already seen the selection of a clinical candidate and the start of IND-enabling investigations, according to.

Since then, the business has created a companion diagnostic candidate to help doctors identify individuals who have biomarkers that could help them get a better clinical response to PR600 than those who don’t. In the third quarter of 2022, Prometheus plans to submit an Investigational New Drug Application for PR600. Prometheus and Dr. Falk Pharma will share responsibility for the global development of PR600 under the terms of the collaboration agreement, which was signed in July 2020, with Dr. Falk Pharma contributing a portion of the external development costs associated with PR600 and its companion diagnostic.

Dr. Falk Pharma will be in charge of regulatory approvals and commercialization of any products in the European Union, the United Kingdom, Switzerland, the European Economic Area (excluding Malta and the Republic of Cyprus), Australia, and New Zealand as part of the agreement. In all other parts of the world, including the United States, Prometheus will be in charge of regulatory clearances and commercialization.