ALK paediatric SLIT-tablet trial meets primary endpoint

16th January 2019 (Last Updated January 16th, 2019 13:04)

ALK has announced positive results from a Phase III paediatric clinical trial of its sublingual allergy immunotherapy (SLIT) tablet to treat allergic rhinitis caused by ragweed.

ALK has announced positive results from a Phase III paediatric clinical trial of its sublingual allergy immunotherapy (SLIT) tablet to treat allergic rhinitis caused by ragweed.

Ragweed is a common cause of hay fever in North America and in some parts of Europe.

The clinical trial lasted for three years and was conducted on 1,022 participants in North America and Europe.

The Phase III, randomised, placebo-controlled trial analysed the efficacy and safety of ALK’s ragweed SLIT-tablet in children aged between five and 17 who had a history of ragweed-induced allergic rhinitis.

The study was intended to analyse whether treatment with SLIT-tablets would lead to a significant reduction in symptoms and medicine used in patients during the peak ragweed season.

"These results are among the most compelling ever seen in large-scale AIT clinical research."

It met its primary endpoint with a TCS reduction of 38% against placebo-treated patients and treatment was well tolerated with a favourable safety profile.

ALK executive vice-president of research and development Henrik Jacobi said: These results are among the most compelling ever seen in large-scale AIT clinical research and demonstrate the potential benefit of treating childhood allergies with these tablets.

"Commercialisation of the tablet portfolio for all relevant ages is a central part of ALK’s growth strategy, and we have recently seen the importance of a paediatric indication for other SLIT-tablets in Japan, where families and doctors have embraced what was a new treatment option for children with allergies.”

The findings of clinically relevant efficacy in children are also in line with the earlier demonstration of its sister product, GRAZAX.

ALK will now start talks with regulatory authorities about extending the present product labelling.

The firm also expects to present additional details from the trial at a scientific congress later in 2019.