BioWorld Today Correspondent

LONDON – Shield Therapeutics Ltd. dosed the first patients in two Phase III studies of its lead product, ST10, for the treatment of iron deficiency anemia, just four months after closing its first round of venture funding.

"We've had a good 18 months," CEO Carl Sterritt told BioWorld Today. "We started to design the protocol about a year ago, and with the funding we were able to go ahead identifying all the centers and getting it all up and running,"

The international, double-blind, placebo-controlled trials are testing ST10 twice daily as a treatment for iron deficiency anemia in patients with ulcerative colitis or Crohn's disease, respectively. Each of the studies will enroll 120 patients who cannot be treated with existing oral iron replacement therapies, with the primary endpoint defined as the increase in hemoglobin levels from baseline to 12 weeks.

The fast read-out and clear clinical endpoint means results are expected before the end of 2012, and the London-based company said it will file then for regulatory approval.

All the centers are in Europe, and Sterritt said the company has yet to talk to the FDA regarding that agency's requirements. "We know they will want two placebo-controlled trials, which is why we've structured the studies as we have."

According to Shield, up to one-third of patients with ulcerative colitis and Crohn's suffer from recurrent anemia. Many are not able to tolerate currently marketed oral iron treatments and must receive intravenous iron therapy.

ST10 consists of ferric iron chelated with maltol, a formulation that Shield said protects it from the effects of stomach enzymes. The compound is absorbed via active transport mechanisms in the gastrointestinal tract, and unlike marketed formulations based on ferrous sulphate, any iron that is not taken up remains in its chelated form and is excreted, thus avoiding side effects.

The clinician behind ST10 is Richard Thompson, a gastroenterologist who serves as president of the UK's Royal College of Physicians. Thompson was motivated by frustration at the poor treatment options for patients who have become anemic as a result of impaired iron absorption and/or bleeding from the gastrointestinal tract caused by ulcerative colitis and Crohn's.

In academic clinical trials, ST10 was effective in treating iron deficiency anemia, including in patients who were intolerant to ferrous iron products. Prior to the commencement of the Phase III trials, more than 400 healthy volunteers and patients with anemia had received ST10.

Shield acquired the compound when it was founded in 2008. In June, Shield raised €8.2 million (US$11.97 million) in a first round of venture capital funding, from a single investor, Inventages Venture Capital. That funding followed three rounds of investment by Shield's founders, family and friends.

The company also has backing from an Austrian pharmaceutical firm, AOP Orphan Pharmaceuticals, based in Vienna, Austria, which in November agreed to invest €3 million in two tranches, in return for marketing rights to ST10 in Central and Eastern Europe and the Middle East, plus an equity stake in Shield.

In addition to the two studies that are now up and running, Shield is planning a further Phase III trial of ST10 in the treatment of anemia in patients with chronic kidney disease. Sterritt said the cost of that study is covered by the June funding round.