ALK’s partner MSD has produced encouraging results from a North American Phase III clinical trial of ALK’s investigational sublingual allergy immunotherapy tablet for the treatment of house dust mite allergic rhinitis.
The trial demonstrated a statistically significant improvement in the primary endpoint in favor of HDM SLIT-tablet compared with placebo, according to BioSpace.com. The primary endpoint of the trial was to demonstrate a reduction in the ‘Total Combined Rhinitis Score’ (TCRS) which is the sum of the average daily rhinitis symptom score and the average daily medication score. The treatment also was generally well tolerated, BioSpace.com noted in its article.
MSD officials have informed ALK counterparts that they now plan to discuss the data and the plans for a regulatory submission of a Biological License Application (BLA) for the HDM SLIT-tablet with the US Food and Drug Administration (FDA.) The HDM SLIT-tablet is currently undergoing regulatory reviews in Europe and Japan.
MSD also plans to present the full trial results at an upcoming scientific congress.