TRACON completes meetings with FDA, EMA for Phase 3 TRC-105 trial

TRACON Pharmaceuticals has completed its “End-of-Phase 2” meeting with the U.S. Food and Drug Administration and its “Protocol Assistance Meeting” with the European Medicines Agency (EMA).

An agreement was put into place with both agencies on the matter of key elements surrounding a Phase 3 clinical trial for TRC-105. TRACON expects to begin enrollment for the trial by the end of the year.

“We appreciate the valuable discussions and guidance from our End-of-Phase 2 discussion with FDA and Protocol Assistance Meeting with EMA, and are confident that we have a robust design for TRC105’s first Phase 3 trial,” TRACON President and CEO Dr. Charles Theuer said. “With the successful completion of the regulatory meetings, we are focused on advancing TRC105 as the first potential therapeutic specifically for the treatment of angiosarcoma, an ultra-orphan indication with a high unmet need. We look forward to initiating our Phase 3 program before the end of the year.”