A Phase 3 clinical study of EPIC, an novel drug vepoloxamer from Mast Therapeutics Inc (NYSEMKT:MSTX) has registered top-line results. The biopharmaceutical company that develops clinical-stage treatment for sickle cell syndrome and heart failure says that study was meant to ascertain whether or not it can be used for the treatment of sickle cell disease. However, all did not end up well because the study did not conquer its primary effectiveness endpoints as expected. It did not demonstrate any significant statistics in the reduction of the mean duration of vas-occlusive crisis (VOC).
Brian M. Culley, the Company’s Chief Executive Officer, says that they are very disappointed about the outcome, which was up to their expectations. However, Culley outlines that they use the most advanced imminent data from the leading placebo-controlled clinical trial ever done in sickle cell disease.
But what exactly happened to the study?
The primary objective of the survey was to evaluate the efficacy of vepoloxamer, an evaluation that never came to be. It was a randomized, double-blind, two-arm, and placebo-controlled study which involved individuals with sickle cell disease hospitalized for acute pain typical of vaso-occlusive crisis.
The study did not achieve any significant difference of treatment groups in the intent-to-treat people across the two secondary effective endpoints. The secondary points were meant to judge against the rates of re-hospitalization for vaso-occlusive predicament within 14 days of initial hospital discharge. Nonetheless, despite the failure of the study, there were no cases of death.
What next after the top-line results?
Mast Therapeutics is set to carry out an assessment of the full data set from EPIC. Culley says that they will be carrying out an interim examination of the enduring heart failure examination of vepoloxamer. However, he was quick to state that the company is likely to perform an analysis of the current heart failure trial of vepoloxamer given the new data.
He was also was quick to recap the company’s appreciation of every party; patients, caregivers, and all those who facilitated in conducting the informative study. The company is also considering other options which help in reducing its operational expenses.