Shield Therapeutics announced that Feraccru (ferric maltol), its oral treatment for inflammatory bowel disease (IBD) patients with iron deficiency anemia (IDA), is now available in the U.K.
“There is a real unmet need for a well-tolerated oral iron replacement for IBD patients with IDA who have failed oral ferrous products,” Dr. Tariq Iqbal, consultant gastroenterologist at Queen Elizabeth Hospital in Birmingham, U.K. said in a press release. “Oral ferrous treatments aren’t well tolerated and patients often don’t adhere to treatment; this limits their efficacy. The availability of Feraccru is an important step in helping to fulfill this unmet need and may help reduce the need to progress to IV [intravenous] iron treatments.”
Dr. Iqbal noted that iron therapy given intravenously “works well in IBD,” but its use is complicated by many patients also being on other intravenous medications, like infused biologic therapy. “Feraccru provides another potential option for treating these patients quickly and efficiently,” he said.
Feraccru was tested in a Phase 3 clinical trial program in 128 adults with IDA secondary to IBD, who did not respond to other oral iron products. The 12- and 64-week trials, called AEGIS, showed that Feraccru was both effective and well-tolerated. After 12 weeks of treatments with oral Feraccru (30 mg twice daily), patients showed significant improvement in their hemoglobin levels compared to those given a placebo, and improvement continued through the trial’s safety phase that extended it to 64 weeks. Specifically, two-thirds of patients had normal hemoglobin levels after 12 weeks, and more than 80 percent of those continuing treatment reported normal levels at 64 weeks.
“Based on the highly compelling results generated throughout its clinical trials, we believe that Feraccru is an exciting new oral treatment option for patients who have failed on oral ferrous products,” said Carl Sterritt, founder and chief executive officer of Shield Therapeutics said. “These patients may previously have had to progress to IV iron or might have received no treatment at all.”
According to Crohn’s and Colitis UK, there are around 300,000 people living with IBD in the country, and IDA affects between 36% and 76% of them.