The UK's Shield Therapeutics has presented impressive late-stage data on ST10, a treatment for iron deficiency anaemia in patients with inflammatory bowel disease.
In a Phase III study, ST10, a novel orally-dosed form of ferric iron, delivered a mean improvement in haemoglobin levels of 2.3g/dL, thus "clearly meeting the primary endpoint of haemoglobin change after 12 weeks’ treatment compared to placebo", said Shield. The trial involved 128 patients with anaemia secondary to either Crohn’s disease or ulcerative colitis who had previously failed therapy with oral ferrous products.
The privately-owned, Newcastle-headquartered firm noted that adverse events were mainly gastrointestinal and occurred fairly equally in the ST10 and placebo arms. Full findings from the studies will be presented at scientific congresses in due course.
Europe filing this year
The data will provide the basis of a filing in Europe this year while a second ongoing study looking at ST10 in the treatment of IDA in pre-dialysis chronic kidney disease patients will support a submission to the US Food and Drug Administration.
Commenting on the data, Christoph Gasche of the Medical University of Vienna said that "until now there has been no acceptable oral iron treatment available for the majority of my IBD patients with IDA". He added that the results are "statistically very convincing" and ST10 is also well tolerated "with just two, a very small number of subjects, withdrawing because of adverse effects".
Shield chief executive Carl Sterrit said the results reflect "an important milestone in the development of ST10 as the only effective, low-dose oral iron-replacement therapy without the significant gastrointestinal side-effects of ferrous iron or the high risks associated with intravenous administration of iron". It "presents a significant opportunity for Shield to develop a paradigm-changing treatment that will address a broad range of indications with a strong commercial potential", he said.