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Pagina 9 van de webcast
In Phase 2 studies in F508del/Min and F508del/F508del
patients:
• VX-440 in combination with tezacaftor and ivacaftor was generally
well tolerated and the overall safety profile was favorable
• The majority of adverse events were mild or moderate
• The most common adverse events, regardless of treatment group,
were infective pulmonary exacerbation, cough, sputum increased
and diarrhea
• One patient treated with VX-440 600mg q12h had elevated liver
enzymes >5x ULN and discontinued treatment. One patient treated
with VX-440 600 mg q12h had elevated liver enzymes >8x ULN,
which were observed on the final day of dosing. In both patients,
the elevated liver enzymes returned to normal after treatment
discontinuation or completion.