October 25, 2018 / 6:09 AM / 23 days ago

BRIEF-Galapagos Reports Top-line Interim Results Of FALCON Trial Part 1 In CF

Oct 25 (Reuters) - GALAPAGOS:

* REPORTED ON WEDNESDAY TOPLINE INTERIM RESULTS OF FALCON TRIAL PART 1 IN CF

* PRELIMINARY RESULTS FROM PART 1 OF THE TRIAL SHOW THAT THE DUAL AND TRIPLE COMBINATIONS OF GLPG2451 AND GLPG2222 WITH AND WITHOUT GLPG2737, RESPECTIVELY, WERE GENERALLY WELL TOLERATED DURING THE DOSING PHASE

* THE LONGER-TERM SAFETY FOLLOW-UP IS CURRENTLY ONGOING

* ALL ADVERSE EVENTS WERE MILD TO MODERATE; THERE WERE NO DEATHS AND NO SERIOUS ADVERSE EVENTS REPORTED

* ONE PATIENT WAS PREMATURELY REMOVED FROM THE TRIAL DURING THE DUAL COMBINATION TREATMENT PERIOD FOLLOWING THE DEVELOPMENT OF RASH (ALLERGIC SKIN REACTION)

* PK RESULTS FOR ALL COMPONENTS WERE IN LINE WITH EXPECTATIONS BASED ON PREVIOUS DATA OBSERVED IN HEALTHY SUBJECTS AND/OR CF PATIENTS

* TWO WEEKS` TREATMENT WITH THE DUAL COMBINATION (GLPG2451 AND GLPG2222) RESULTED IN MEAN DECREASE FROM BASELINE IN SWEAT CHLORIDE CONCENTRATION OF APPROXIMATELY 25 MMOL/L AND A MEAN INCREASE IN PPFEV1 OF APPROXIMATELY 3%

* SUBSEQUENT TWO-WEEK TREATMENT WITH THE TRIPLE COMBINATION (GLPG2451, GLPG2222 AND GLPG2737) DID NOT RESULT IN ADDITIONAL ENHANCEMENT OF CFTR ACTIVITY

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Further company coverage: (Gdynia Newsroom)

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