The North American Cystic Fibrosis Conference began yesterday. Concert presented some new data for CTP-656, and Galagapos released phase 1 data for drug GLPG1837 today. Below is new data for drug GLPG1837, and some comparison of CTP-656 and GLPG1837.
The half life (t 1/2) of 1837 runs between 6 and 15 hours depending on the dosage. I selected a middle of the range dosage of 500 mg used in the phase 1, for comparison to CTP-656 regarding plasma concentration, and their distinct profiles.
plasma concentration 500 mg 12 hours fed around 200 (ng/mL)
The half life of CTP-656 is 15 hours with a 150 mg dose.
plasma concentration 150 mg 12 hours fed 1306 (ng/mL)
The half life (t 1/2) of Kalydeco is around 11 hours for a 150 mg dose.
plasma concentration 12 hours fed 412 (ng/mL)
-Concert said CTP-656 was similar to Kalydeco at all dose levels, and well tolerated up to 300 mg.
-Galagapos 500 mg dosed twice daily with six participants, all experienced tiredness, and five experienced headache, in healthy subjects. Galagapos says final safety data is pending.
From the data above, it looks like GLPG1837 will have to be dosed twice daily judging by the half life range of 6-15 hours, and Galagapos did not breakout each individual dose with half life. Two distinct drugs, as plasma levels with CTP-656 150 mg at 12 hours is substantially higher than GLPG1837 500 mg. Concert believes that QD dosage (once daily) is possible with CTP-656. The company still has to run a multiple ascending dose phase 1 trial, evaluating CTP-656 against Kalydeco. Galagapos plans to initiate a phase 2 clinical trial for CF patients by the end of 2015. Thank you for reading. No positions in Galagapos.