Subcutaneous beloranib: Phase IIb halted

Zafgen closed the randomized portion of the Phase III bestPWS (ZAF-311) and Phase IIb ZAF-203 trials evaluating beloranib to treat obesity. bestPWS is evaluating twice-weekly 1.8 and 2.4 mg doses of subcutaneous beloranib for 6 months in 108 patients with Prader-Willi syndrome. ZAF-203 is evaluating 1.2 and 1.8 mg subcutaneous beloranib twice weekly for 12 months in 152 Type II diabetics. The company said it will analyze data from both shortened trials and that FDA has agreed to review an abbreviated application. Last month, FDA placed a clinical hold on the product after a patient receiving beloranib died in bestPWS (see BioCentury, Oct. 19). ...