Fortress completes Phase I enrollment of amyloidosis candidate CAEL-101

Fortress Biotech Inc. (NASDAQ:FBIO) completed enrollment of about 42 patients in a Phase Ia/Ib trial of IV CAEL-101 (11-1F4) to treat amyloid light-chain (AL) amyloidosis. The open-label, dose-escalation, U.S. trial is determining the maximum tolerated dose (MTD) as the primary endpoint and evaluating the proportion of patients with positive amyloid-related organ response, safety and pharmacokinetics as secondary endpoints. In the Phase Ia portion, patients received a single injection of up to 500 mg/m² CAEL-101. In the Phase Ib portion, patients received up to 500 mg/m² CAEL-101 once weekly for 4 weeks.

Fortress expects preliminary data from the trial in mid-2017 and full data by year end. Fortress also plans to start a Phase II trial of the chimeric fibril-reactive mAb in 1H18...