Shire announces 'clinically significant' results in Sahara trials

UK based biotechnology group Shire announced positive top line results for its phase three study on Sahara, a subcutaneously administered C1 esterase inhibitor liquid.

Measured against a placebo over two 14-week periods in patients 12-years or older with hereditary angioedema (HAE), Sahara was evaluated on its ability to prevent angioedema attacks in patients that suffer from recurrent swelling of the extremities, gastrointestinal tract, and upper airways.

"Patients want and deserve options when it comes to their treatment for HAE," said Dr William Lumry, clinical professor of Internal Medicine at Southwestern Medical School in Dallas. "These results are clinically significant, meaningful and relevant to HAE patients whose needs are currently not met today."

The study, which reached its primary and all key secondary endpoints, lead to a reduction of 2.32 attacks per month with 78% of patients experiencing a reduction of 50% or more in HAE attack rate with no serious treatment-related adverse effects or deaths.

"In developing medicines for HAE patients over the last decade, we know that treating physicians and patients suffering from HAE look for efficacious, safe and convenient treatment and prevention options, and we continue to strive to meet as many of these needs as possible through continued innovation," said Howard Mayer, interim head of research and development at Shire.

"We are very pleased with the strong results of this study, which demonstrated efficacy with a low volume dosing regimen, and what it potentially could mean for the global HAE community if approved."

As of 1250 BST, shares had moved ahead 1.04% to 4,079.60p.