Shield Therapeutics () has provided further conclusions from its analysis of data from the AEGIS-H2H study comparing the company’s oral iron replacement treatment Feraccru to intravenous (IV) iron. The outcomes of the analysis are strongly supportive of ongoing discussions for the global commercialisation, pricing and reimbursement of Feraccru. This includes supporting STX’s partner Norgine to negotiate on pricing and coverage decisions in the broader European markets as well for ASK Pharm, the company’s partner in China. Moreover, with the analysis complete, the long term clinical durability of Feraccru (to be called Accrufer in US), its cost-efficacy and ease-of-use when compared to the standard IV iron, support discussions with potential US partners. A licensing deal in the US for Accrufer can start to unlock the world’s largest iron replacement market which represents c70% of the estimated US$3bn value of the global market.
The AEGIS-H2H study was a multi-national Phase IIIb randomised study in 250 inflammatory bowel disease patients with mild-to-severe iron deficiency anaemia (IDA). Significantly, the AEGIS study was intended to provide a comparison between Feraccru and IV iron therapy for the purposes of generating health economic and other data showing how the treatments compare over a 52-week period, not as a registration study. Therefore, the study does not affect the regulatory status of Feraccru, which is supported by the successful outcomes of two pivotal clinical studies.
The study was conducted over a 52-week period with measurements taken at weeks 12, 24, 36 and 52. The patients included in the study had very low baseline haemoglobin (Hb) levels in some cases as low at as 8.0g/dL compared to WHO definition of normal Hb of 12g/dL for women and 13g/dL for men. The primary endpoint of the study was non-inferiority measured as the response rate defined as normalisation of Hb levels or an increase of at least 2g/dl in Hb from patients' baseline levels normalisation of Hb levels or an increase of at least 2g/dL in Hb from patients' baseline levels in both the intention to treat (ITT) and per protocol (PP) groups compared to the IV iron arm. ITT includes all patients including those who drop out and can be considered to more accurately reflect a real world setting than the PP group, which only includes those who remain in the study for its duration.
Treatment outcomes for the short-term at the end of the 12-week period showed that in the Feraccru arm, 67% of the intention to treat (ITT) population and 68% of the per-protocol (PP) population had responded to treatment. In the IV arm, 84% of the ITT population and 85% of the PP population had responded meaning that Feraccru did not achieve non-inferiority at 12 weeks in the primary endpoint in either population. However, there was a clinically significant response rate measured as the mean increase in Hb levels per patient in the Feraccru arm of 2.45 g/dL for the ITT population and 2.57 g/dL in the PP population, compared with 3.04 g/dL and 3.05 g/dL respectively for IV-treated patients.