Beloranib is a potent inhibitor of Methionine aminopeptidase-2 that reduces hunger while stimulating the use of stored fat as an energy source (MetAP2), which is an enzyme that modulates the activity of key cellular processes that control metabolism.
Zafgen CEO Thomas Hughes said the company is happy that its application for orphan drug designation of beloranib has been positively reviewed and granted by the EC.
"On the basis of our Phase 2 results reported earlier this year, we believe beloranib represents a promising new approach for the treatment of PWS, with the potential to meaningfully improve the lives of patients with this severe and life-threatening condition," Hughes said.
"We are dedicated to the advancement of beloranib for the treatment of PWS and other severe forms of obesity and we look forward to initiating our Phase 3 clinical program in PWS later this year."
The company received orphan designation from the US Food and Drug Administration (FDA) for beloranib in January 2013 for the treatment of Prader-Willi syndrome.
Initial data from the Phase II trial of beloranib in Prader-Willi syndrome patients showed improvements in hunger-related behaviours and body composition, including reductions in body fat content and preserved lean body mass.
The company has exclusively licensed beloranib from South Korea-based Chong Kun Dang Pharmaceutical.