- Mast Therapeutics (MSTX) says phase-3 EPIC trial of vepoloxamer, which treats individuals with sickle cell disease experiencing vaso-occlusive crisis, did not meet its primary efficacy endpoint.
- Endpoint was statistically significant reduction in the mean duration of VOC (82 hours in the vepoloxamer group compared to 78 hours in the placebo group in the intent-to-treat population (p=0.09)). There were no statistically significant differences between treatment groups in the intent-to-treat population across the two secondary efficacy endpoints, rate of re-hospitalization for VOC and the occurrence of acute chest syndrome.
- Company: "We are exceedingly disappointed with these top-line results... These analyses are limited to just top-line data, so in the coming weeks the Company intends to review the full data set from EPIC. In addition, we plan to perform an interim analysis of the ongoing heart failure trial of vepoloxamer.
- "However, based on the data we've seen to date, we expect we will terminate all clinical development of vepoloxamer. Consequently, while we evaluate our options, we intend to significantly and immediately reduce our operating expenses and continue our efforts with AIR001, our lead asset in heart failure with preserved ejection fraction, which currently is the subject of a 100-patient phase 2 study expected to complete enrollment by the end of 2017."
- Conference call tomorrow, September 21, 2016, at 8:00 a.m. ET / 5:00 a.m. PT to discuss the results.
- Shares -78% to $0.13 AH.