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Shield Therapeutics revises study data as FDA mulls drug application
Shield Therapeutics has revised analysis from its recent clinical study into its treatment for iron-deficient adults, withdrawing some patient data after meeting with US drug regulators.
The AIM traded pharmaceutical company said some patients that were "experiencing pre-specified events" had their data removed from the study analysis of salt based oral iron therapy Feraccru.
Shield believes the inclusion of data from these patients could have "significantly impacted" the primary endpoint of the study so further analyses of the data have been conducted using an amended statistical analysis plan that removed their data.
Carl Sterritt, chief executive of Shield Therapeutics, said: "I am reassured that we have rapidly been able to understand what we believe occurred in the study to produce the initial topline result. This has enabled us to take appropriate and well-controlled steps to prepare a data package."
The new data package yields more positive results for Shield as data showed patients treated with feraccru saw a significant response (p=0.0149) in haemoglobin levels after 16 weeks compared to placebo (difference 0.52g/dl (CI 0.102, 0.930) with statistically significant results achieved across a range of secondary iron parameters (TSAT, Ferritin levels, serum iron levels)
The company said there is "no certainty" that the US Food & Drug Administration will accept the approach it has taken with regard to the study.
Shield has presented the revised data from the double blind study to the FDA as part of a new drug application.
"The outcome of the FDA's deliberations on our submissions will help inform the group's ongoing strategic review, which it intends to update shareholders on as soon as possible. In the meantime further routine analysis of the dataset will continue to deepen our understanding of the effect of Feraccru on IDA in CKD patients," said Sterritt.
As of 0834 GMT, Shield Therapeutics' shares were unchanged at 17.50p.