Galapagos is aggressively pursuing drugs for people living with cystic fibrosis. We previously wrote about Galapagos extensively here Galapagos. Their previous top candidate, potentiator GLPG1837, has now been put on hold for a much more convenient once daily dosed potentiator GLPG2451. The drug has completed the safety phase 1 clinical trial in healthy subjects, and by Galapagos standards was viewed as ready for a phase 1 combo trial with their lead corrector GLPG2222. The ultimate goal for the company is to develop a triple combination for people with the F508del mutation, which represents around 90% of the total CF population. The phase 1 and 2 clinical trials are being funded almost 100% by their partner AbbVie. If this phase 1 combo clinical trial passes the safety test, then a third component corrector GLPG2737, which is currently in the safety phase of testing, will then be added to the combo 2451 and 2222 to form the triple. The big picture goal is to produce a better therapy than currently approved Vertex's two drug combo Orkambi. A once daily triple combo would be advantageous for CF patients that may take up to 20-40 pills per day for this disease.
Interim Analysis of 2451 and 2222
According to Galapagos, an interim analysis will be conducted on the combo mid-year. If the combo passes the safety test, then corrector #2 GLPG2737 will then be added to the mix, and the three drugs will be tested for CF patients with F508del around third quarter of 2017. So, by the end of 2017, the first triple combination (one potentiator, and two correctors) will be tested. However, if the current phase 1 clinical trial with 2451 and 2222, does not produce an acceptable drug/drug interaction safety profile in healthy participants, then the entire project would be delayed.
CTP-656 in Phase 2
Concert Pharmaceuticals CTP-656 is currently in a phase 2 clinical trial as mono-therapy for CF patients harboring the G551D mutation. The drug is dosed once daily, and has shown head to head comparison's with Kalydeco in several early clinical trials with PK advantage. The drug could fit nicely into the mix for a combo also, with two correctors, dosed as one simplified daily pill for F508del CF patients.
Bottom Line:
We'll monitor progress of the Galapagos combo clinical trial (2451 + 2222), and CTP656's phase 2 clinical trial that is scheduled to complete by the end of 2017. Thank you for reading.
Interim Analysis of 2451 and 2222
According to Galapagos, an interim analysis will be conducted on the combo mid-year. If the combo passes the safety test, then corrector #2 GLPG2737 will then be added to the mix, and the three drugs will be tested for CF patients with F508del around third quarter of 2017. So, by the end of 2017, the first triple combination (one potentiator, and two correctors) will be tested. However, if the current phase 1 clinical trial with 2451 and 2222, does not produce an acceptable drug/drug interaction safety profile in healthy participants, then the entire project would be delayed.
CTP-656 in Phase 2
Concert Pharmaceuticals CTP-656 is currently in a phase 2 clinical trial as mono-therapy for CF patients harboring the G551D mutation. The drug is dosed once daily, and has shown head to head comparison's with Kalydeco in several early clinical trials with PK advantage. The drug could fit nicely into the mix for a combo also, with two correctors, dosed as one simplified daily pill for F508del CF patients.
Bottom Line:
We'll monitor progress of the Galapagos combo clinical trial (2451 + 2222), and CTP656's phase 2 clinical trial that is scheduled to complete by the end of 2017. Thank you for reading.
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