aston.martin schreef op 26 oktober 2016 09:04:
[...]
De voorziene ontwikkelingen van fase 2 en fase 3, zoals ze gisteren door Vertex zijn voorgesteld, staan toch wel in zeer schril contrast met het tijdsschema van Galapagos. Ik hoop dan ook dat dit schema snel herzien wordt.
GLPG2737 zou nu trouwens toch wel stilaan fase 1 mogen beginnen als ze midden 2017 de triple combo in patiënten willen testen...
Uit het rapport van Morgan Stanley van 10 oktober n.a.v. gesprekken met het management van Galapagos:
Mgt.also answered a number of keyinvestor questions: (1) On
the potential PhII triplecombination trial design, mgt. indicated it would likely
pursue both PhIIa and PhIIb studies. The PhIIa (still likely conducted in Europe
only) would look at four week endpoints from initial triple combinations. If mgt.
moves into the clinic by mid-2017 (current guidance), data would be expected in
2018. The PhIIb would explore three doses for 13 weeks in both
homo/heterozygote mutations with data likely ~1.5 years after study initiation.
Thus, mgt. would expect a PhIII start by mid-2019. Mgt. would not expect to run
monotherapy studies in PhIIb, but could need to complete smaller 'flanking'
studies of some doublet combinations; (2) On thesecond corrector GLPG-2737,
mgt. remained confident that itnow has the right corrector and remains on its
timeline to complete necessary clinical work to advance the triple combination;
het volledige rapport:
www.iex.nl/Forum/Upload/2016/9629092.pdf