Brief: Alk-Abello Says Phase 3 Clinical Trial For HDM Tablet Meets Primary Endpoint
08/06/2023 15:58
June 8 (Reuters) - ALK-Abello A/S ALKb.CO :
* LARGE PHASE 3 CLINICAL TRIAL SUCCESSFULLY MEETS PRIMARY
ENDPOINT, CONFIRMING THE POTENTIAL OF ALK’S HOUSE DUST MITE
TABLET IN YOUNG CHILDREN
* PRIMARY AND ALL KEY SECONDARY CONFIRMATORY ENDPOINTS WERE
MET
* IMPROVEMENT IN TOTAL COMBINED ALLERGIC RHINITIS SCORE
(TCRS) OF
22% COMPARED TO PLACEBO
* RESULTS WERE HIGHLY STATISTICALLY SIGNIFICANT AND
CONSISTENT
ACROSS MULTIPLE ENDPOINTS
* WILL NOW PURSUE A DIALOGUE WITH RELEVANT REGULATORY
AUTHORITIES
ABOUT EXPANDING CURRENT PRODUCT INDICATIONS
* SUBJECT TO APPROVAL, HDM TABLET COULD BE AVAILABLE FOR
YOUNG
CHILDREN IN EUROPE AND NORTH AMERICA IN 2024/25
* EXPECTS TO PRESENT FURTHER DETAILS FROM TRIAL AT A
SCIENTIFIC
CONGRESS LATER IN 2023/24
* ALK EXPECTS TO REPORT TOP-LINE RESULTS FROM ITS PHASE 3
PAEDIATRIC TRIAL WITH TREE POLLEN TABLET ITULAZAX IN Q4 2023
Source text for Eikon: ID:nL8N3803R9
Further company coverage: ALKb.CO
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