Shire PLC (ADR) (NASDAQ:SHPG) shares are surging in pre-market on Thursday after the company announced positive results from its phase three study on Hereditary angioedema (HAE). The company revealed that its final stage trial for the HELP, which is a multi-center, randomized, double-blind placebo-controlled parallel group, assessed the efficacy, as well as, safety of subcutaneously administrated lanadelumab compared to placebo during the 23-week period in patients of above 12 years of age.
Shire pointed that HAE is a rare, genetic disorder that is projected to affect approximately one in 10,000 to one in 50,000 people around the globe. The company believes that the situation results in recurrent, localized edema (swelling). The biotech firm cited areas of the body that most commonly affected. It included the extremities, gastrointestinal tract, and upper airways. The company believes that the swelling could be debilitating and painful, potentially impacting both work and education for people living with HAE.
The company’s CEO, Flemming Ornskov, reacted to the developments to comment “We are extremely encouraged by these topline Phase 3 results. We have nearly a decade of experience and a strong portfolio and pipeline in HAE and believe these data demonstrate high potential for transforming the way patients living with this condition are treated.”
Shire indicated that it intends to submit a biologics license application (BLA) for assessment by the U.S. Food and Drug Administration (FDA) during the later part of the current year or early next year. The biotech firm pointed out that 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).
At time of writing this, Shire shares are trading up 7.32 percent at Nasdaq.