Shield Therapeutics reports positive data from reanalysis study
Shares in jumped on Thursday after the group released findings of a reanalysis of the AEGIS-H2H study for its iron deficiency lead product Feraccru®/Accrufer®.
The study was designed to provide data comparing oral Feraccru®/Accrufer® (ferric maltol) against intravenous iron therapy to allow economics data and other analysis to be generated.
The study was not intended as a registration study, the pharmaceutical company explained, and the regulatory status of Feraccru®/Accrufer® remains unaffected by the study.
In March, Shield released a complete review of the analysis which it said had not reached its primary endpoint. The review is now complete with an independent statistical review.
The renalysis confirms Feraccru®/Accrufer® as a credible alternative to IV therapy for iron deficiency anaemia and corrects anaemia and maintains long-term hemoglobin (Hb) levels.
Shares in Shield Therapeutics jumped from 91.50p to 127p at close on Thursday afternoon.
The primary endpoint of the study was defined as achieving non-inferiority in the proportion of responders in both the "intention to treat" (ITT) and "per protocol" (PP) populations, out of 250 inflammatory bowel disease (IBD) patients, at the end of the initial 12 week study.
This period was followed by a 40-week extension phase, during which patients continued treatment with Feraccru®/Accrufer® or received IV iron infusions in line with clinical need.
The purpose of this second phase was to understand how well each therapy maintained Hb levels and corrected anaemia and to enable evaluations of health economic outcomes. This remained broadly unchanged, demonstrating that the therapy compares favourably with IV.
One of the study investigators, Dr Stephanie Howaldt, said, “This analysis showed clinical meaningful responses with both ferric carboxymaltose and ferric maltol after 4 weeks and the results are consistent with the ferric maltol pivotal Phase III study programme.”
She added, “Most importantly, ferric maltol demonstrated comparable effectiveness at maintaining Hb and iron status for up to 52 weeks, preventing relapse, which was seen frequently in the ferric carboxymaltose group, requiring additional IV therapy.”
“Having resolved the anomalies seen in the original analysis the study results can now be used with confidence for further health economics analysis and to support pricing and reimbursement applications in Europe,” said Tim Watts, CEO of Shield Therapeutics.
Shield has told investors that it plans to publish the full AEGIS-H2H study results in a peer-reviewed paper in due course.
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