Mast Therapeutics has initiated an open-label, multicentre Phase 3 extension study of vepoloxamer (MST-188) in sickle cell disease, referred to as “EPIC-E”.
The study will enroll patients who have completed the Company’s Phase 3 EPIC study and are hospitalised for a subsequent vaso-occlusive crisis. The study will assess the safety and tolerability of repeat administration of vepoloxamer. Secondary objectives are to assess the rate of re-hospitalisation for recurrence of vaso-occlusive crisis and the occurrence of acute chest syndrome.
EPIC-E data will enhance the quality of a New Drug Applicatoin for vepoloxamer in sickle cell disease
“We continue to be excited about the potential for vepoloxamer, which is years ahead of other investigational treatments for sickle cell disease,” stated Brian M. Culley, Chief Executive Officer. “We have initiated EPIC-E consistent with our prior guidance and plan to make this extension study available at almost all of our more than 70 EPIC sites.”
“We believe data from EPIC-E will enhance the quality of a New Drug Application for vepoloxamer in this rare disease, as well as contribute to enthusiasm for the EPIC study,” stated Dr Edwin L. Parsley, Chief Medical Officer.
“In particular, for patients who may be hesitant to participate in EPIC because they may be randomly assigned to receive the placebo control, EPIC-E can provide the certainty of receiving vepoloxamer for subsequent crises. EPIC-E also will give study investigators experience administering vepoloxamer to sickle cell patients in an unblinded manner, which we expect will provide valuable feedback for us,” continued Dr Parsley.
The Company also plans to initiate a Phase 2 study of vepoloxamer in chronic heart failure in the third quarter of this year.
