Concert presented at the European Cystic Fibrosis Society today, and presented phase 1, multiple dosing with solid tablet results, for CTP-656 in healthy volunteers. We initially were given top-line results in April, so there were not many surprises today. The important information to consider from this completed phase 1 clinical trial with 7 days of dosing, is the following below under fed conditions.
CTP-656 to M1 Ratios
Single dose CTP-656 to M1 ratio = 1.5
7th day dose CTP-656 to M1 ratio = 1.8
With CTP-656, the highest exposure is to the most active species (parent).
With Ivacaftor, the highest exposure is to the less-active metabolite (M1) (20% active relative to Ivacaftor).
Next step for Concert and CTP-656, is to initiate a phase 2 efficacy clinical trail by the end of 2016. Thank you for reading.
CTP-656 to M1 Ratios
Single dose CTP-656 to M1 ratio = 1.5
7th day dose CTP-656 to M1 ratio = 1.8
With CTP-656, the highest exposure is to the most active species (parent).
With Ivacaftor, the highest exposure is to the less-active metabolite (M1) (20% active relative to Ivacaftor).
Next step for Concert and CTP-656, is to initiate a phase 2 efficacy clinical trail by the end of 2016. Thank you for reading.
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