- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Positive Phase III Results Reported for Oral Ferric Iron in Anemic Patients With Irritable Bowel Disease
Therapy offers alternative to IV iron treatment (January 7)
Positive data have been reported from the pivotal phase III program for ST10 (Shield Therapeutics) in the treatment of iron deficiency anemia (IDA) in patients with inflammatory bowel disease (IBD).
ST10, an orally dosed form of ferric iron, provided a mean improvement in hemoglobin levels of 2.3 g/dL (P < 0.0001), meeting the primary endpoint of the hemoglobin change after 12 weeks of treatment, compared with placebo.
More than 65% of treated subjects experienced normalized hemoglobin levels by week 12. ST10 also provided significant improvements in hemoglobin levels at 4 weeks (1.1 g/dL, P < 0.0001) and 8 weeks (1.8 g/dL, P < 0.0001) of therapy.
ST10 was evaluated in 128 patients with anemia secondary to either Crohn’s disease or ulcerative colitis who had previously failed therapy with oral ferrous products because of intolerance and/or inadequate therapeutic benefit. The patients were randomly assigned to receive ST10 or a matched placebo capsule. Other iron therapies were not permitted during the study.
Adverse events were mainly gastrointestinal in nature and occurred at similar rates in the ST10 and placebo arms (38% and 40%, respectively). Withdrawal from the study before 12 weeks (due to adverse events or the patient’s decision) occurred in seven ST10-treated patients and in nine placebo-treated patients. Those who completed the 12-week double-blind phase of the study continued treatment in a 12-month open-label extension phase. Data from the extension phase will be available later this year.
The study results will form part of a New Drug Application submission to the FDA.
Source: Shield Therapeutics; January 7, 2014.