CymaBay's (CBAY) MBX-8025 Granted EMA PRIME Designation

October 20, 2016 8:04 AM EDT

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CymaBay Therapeutics, Inc. (Nasdaq: CBAY) announced that MBX-8025 has been granted the PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) for the treatment of primary biliary cholangitis (PBC) in patients who do not tolerate or respond to ursodeoxycholic acid (UDCA) or do not respond to combination UDCA / obeticholic acid treatment. MBX-8025 is an orally administered potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist currently in Phase 2 clinical development.

The PRIME program has been launched by the EMA Committee for Medicinal Products for Human Use (CHMP) to enhance support for the development of medicines that target an unmet medical need with a focus on medicines that may offer a major therapeutic advantage over existing treatments. This program is designed to provide enhanced interaction and early dialogue between developers of promising medicines and the EMA in order to optimize development plans, speed up evaluation and, thereby, help patients benefit as early as possible from therapies that may significantly improve their condition or quality of life.

“Patients will be delighted to hear that the EMA has recognized, in an ongoing manner, the unmet need for new therapies for patients with PBC. In particular, this is of note to those individuals not currently getting the optimal benefit from presently available drugs such as UDCA or obeticholic acid,” said Dr. Gideon Hirschfield, from the Centre for Liver Research, University of Birmingham. “PRIME designation of MBX-8025 reinforces the interest and potential seen for this agent going forward, providing CymaBay with high level guidance and pathway management from early phase trials through to drug approval.”

“We are very pleased that the CHMP has recognized MBX-8025 as a potential breakthrough therapy for the treatment of PBC,” said Harold Van Wart, President and Chief Executive Officer of CymaBay Therapeutics. “Participation in the PRIME program increases the opportunities for interaction and dialogue with the EMA and will allow us to optimize the development program, potentially accelerating the access of MBX-8025 to patients with PBC."



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