Vifor Pharma has reported data from the AFFIRM-AHF clinical trial of Ferinject (intravenous ferric carboxymaltose) in iron-deficient patients hospitalised due to acute heart failure (AHF).
The trial did not reach statistical significance on its composite primary endpoint of decreasing the risk of total heart failure hospitalisations and cardiovascular death.
Ferinject is a non-dextran-based intravenous iron replacement therapy with ferric carboxymaltose as the active pharmaceutical ingredient.
AFFIRM-AHF analysed the effect of the drug candidate on heart failure hospitalisations and cardiovascular mortality.
As many as 1,132 patients were randomly given Ferinject or placebo before their hospital discharge after an episode of AHF and were followed for 52 weeks.
The randomised, double-blind placebo-controlled study showed that the drug was well tolerated, without any new safety findings.
The trial’s principal investigator Piotr Ponikowski said: “The totality of evidence from the trial suggests that treatment with intravenous ferric carboxymaltose of patients’ hospitalised due to AHF with concomitant iron deficiency is clinically beneficial.”
A pre-specified sensitivity review, which considered Covid-19’s impact, found that the drug candidate led to a statistically significant difference on cardiovascular mortality and hospitalisation for heart failure.
Vifor Pharma chief medical officer Klaus Henning Jensen said: “Iron deficiency is a frequent yet often unrecognised co-morbidity in heart failure, present in approximately 50% of patients.
“Ferinject is the only iron therapy included in the ESC guidelines to improve clinical symptoms and quality of life in heart failure patients with iron deficiency.”
The company will present the trial data at the American Heart Association congress in November.
Apart from AFFIRM-AHF, the company initiated FAIR-HF2 and HEART-FID trials in July 2017 to test the efficacy of Ferinject on morbidity and mortality outcomes in systolic heart failure and iron deficiency patients.