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Vifor Pharma receives positive phase-I trial results for oral ferroportin inhibitor

Regulatory News:


Vifor Pharma is pleased to report positive phase-I trial results for its
oral ferroportin inhibitor. The trial which was conducted amongst
healthy volunteers over a period of 9 months, concluded in October 2018.
Trial subjects received single oral doses of VIT-2763 (ferroportin
inhibitor) from 5 mg to 240 mg, or multiple doses from 60 mg to 120 mg
once or twice daily over 7 days.


In all treated trial participants, the ferroportin inhibitor was well
tolerated with mild to moderate side effects that were transient and
self-limiting. The human pharmacokinetic profile exhibited dose-linear
exposure, following which serum iron was lowered and remained below
baseline values up to 24 hours post-dose. This iron-lowering
pharmacodynamic effect is consistent with observations in preclinical
models.


Following these positive phase-I results, Vifor Pharma intends to start
a phase-II proof-of-concept trial in the second half of 2019. This will
be a phase-II randomized, controlled, multi-national trial conducted in
patients with beta-thalassemia and documented iron overload.


VIT-2763 is an oral inhibitor of ferroportin, the only known mammalian
iron exporter and essential for transport of iron from one cell type to
another. Preclinical models had already shown that VIT-2763 decreases
serum iron levels in a dose-dependent manner1.
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