Irish pharmaceutical company Shire has reported positive topline results from its Phase III HELP clinical trial of lanadelumab to treat hereditary angioedema (HAE) and from the Phase II TURANDOT trial of SHP647 (PF-00547659) for the treatment of ulcerative colitis.
Lanadelumab is an investigational, fully human monoclonal antibody designed to inhibit plasma kallikrein, while SHP647 is an anti-mucosal addressin cell adhesion molecule 1 (MAdCAM-1) antibody.
The results from multi-centre, randomised, parallel group, double-blind, placebo-controlled HELP trial showed that biweekly and monthly lanadelumab met both primary and secondary endpoints with a statistically significant decrease in mean attack frequency of HAE.
The trial assessed the efficacy and safety of 150mg and 300mg of subcutaneous lanadelumab for 26 weeks in 125 patients aged 12 or older.
The drug was found to be well-tolerated, with no treatment-related serious adverse events or deaths.
The results from Phase II TURANDOT trail indicated that all the 7.5mg, 22.5mg, 75mg and 225mg doses of SHP647 met the primary endpoint with significant remission rates.
The multi-centre, double-blind, placebo-controlled, parallel group trial evaluated the drug in 357 adults with moderate-to-severe ulcerative colitis over 12 weeks.
The remission rates were found to be greater when treated with 22.5mg and 75mg of SHP647.
The drug also met the secondary endpoints of clinical response and mucosal healing and was found to be well-tolerated.
Last year, the firm licensed the global rights of SHP647 to all indications from Pfizer. In the third quarter of this year, it plans to start a Phase III trial to assess the drug.
Lanadelumab also obtained orphan drug designation from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and breakthrough therapy designation from the FDA.
Later this year or early next year, Shire intends to submit a biologics licence application (BLA) to the FDA for lanadelumab.