Shield poised for FDA decision on Feraccru for anemia – Shield Therapeutics (STX) should hear at some point over the next two weeks whether the FDA will approve its oral iron supplement Ferracru for treatment of iron deficiency. The decision, due by 26 July, is of course important but is further complicated by a statistical issue with the company’s phase III data.
Shield decided to conduct an interim analysis of its AEGIS-CKD pivotal study in February 2018 at the end of the first study phase at 16-weeks of treatment. Unfortunately, these results included confounding data (including patients who had undergone withdrawal events like rescue treatment with IV iron or bleeding events unconnected to treatment, but who had remained in the study) and as a result, the initially published topline outcome was negative in terms of meeting the study’s primary endpoint. However, a subsequent detailed analysis of data showed that if this confounding resutls were excluded by adjusting the patient inclusion criteria, the study would have rendered data that met the primary and secondary endpoints. However, regulators are highly loathe to accept applications for review based on such post hoc changes, but seem to have done so on this occassion.
The company’s stock fell heavily on the initial announcement and did not recover on the subsequent adjusted and now positive announcement. The shares have, however, started to recover this year, rising three-fold, investors seemed to believe Ferracru will be approved in the US. If and when approved, Shield intends to seek a US licensee.