Shares in Shire Plc (LON:SHP, NASDAQ:SHPG) rose after it published positive results of a trial of a treatment for swelling under the skin (angioedema).
In London, the shares were up 4.6% at 4,952p as the company said its investigational treatment lanadelumab was shown to reduce the hereditary angioedema (HAE) monthly attack rate by 87% in a Phase 3 26-week pivotal trial.
Data from the trial will form the basis of a biologics licence application (BLA) for evaluation by the US Food and Drug Administration (FDA).
Lanadelumab has already received both Orphan Drug Designation and Breakthrough Therapy Designation from the FDA and Orphan Drug Designation from the European Medicines Agency (EMA), which basically means the drug will be fast-tracked through the regulatory process.
“If approved, lanadelumab may offer patients a long-acting treatment option that significantly reduces HAE attacks when administered subcutaneously [beneath the skin] as infrequently as every four weeks,” said the clinical trial’s investigator, Aleena Banerji, MD, of Massachusetts General Hospital in Boston, Massachusetts.
The condition is not normally life threatening, unless it affects the throat, but can be very painful. The genetic disorder is estimated to affect between one in 10,000 and one in 50,000 people worldwide, and tends to affect the hands, feet, area around the eyes, the lips and tongue and the genitals.
Shire’s lanadelumab was generally well tolerated over the 26-week treatment period. No treatment-related serious adverse events or deaths were reported. The most common adverse event was pain around the area where the injection was made.