There are two cystic fibrosis conferences approaching. The first is the UK Cystic Fibrosis Trust, that will start next week. The second conference is the NACFC North American Cystic Fibrosis Conference which will start October 7th. This is what we could potentially learn from both conferences regarding what is relevant to our investment.
UK Conference
CTP-656 single dose comparison with Kalydeco as placebo.
This will be the first in human clinical trial, to assess the PK, and compare against the current standard of care (Kalydeco) for CF patients. CEO Tung has already alluded to the comparison as being "significant" from a metabolic point of view. Concert will be presenting a late breaking abstract at this conference. What this means for CF patients, is that CTP-656 could potentially be dosed as a once daily, and improve on the drug to drug interaction profile over Kalydeco. We will be looking for the t1/2 life percentage improvement over Kalydeco, in addition to the AUC. The US patent extends out five years further to 2032 over Kalydeco 2027.
NACFC Conference
CTP-656 single ascending dose comparison with Kalydeco as placebo. Kalydeco is dosed 150 mg twice daily. This part of the phase 1, could tell us what an equivalent dose to 150 mg Kalydeco, could be attained with the deutered CTP-656 as single daily dosing. Following this will be a the multiple ascending dose part of the phase 1 trial, that should conclude early 2016.
GLPG1837 Galapagos (GLPG) is in a phase 1 clinical trial to assess the safety, tolerability, and the PK of potentiator GLPG1837, against placebo in healthy volunteers. From the NACFC abstract.
This randomized, double-blind, placebo-controlled study was designed to assess the safety, tolerability and pharmacokinetics of GLPG1837 in healthy volunteers over a range of single and multiple doses. In the single ascending dose (SAD) part of the study, 2 alternating cohorts of subjects are exposed to single oral doses of 30 to 2000 mg in fasted conditions (with 500 mg further evaluated after a high-fat high-calorie breakfast). The multiple ascending dose (MAD) part of the study is designed to administer GLPG1837 orally at doses of 125 to 500 mg b.i.d. for a period of 14 days. At the time of submission of this abstract the study was still ongoing. GLPG1837 has been safe and well tolerated up to the 1500 mg single dose (latest dose tested), with no dose-related abnormalities on any of the safety parameters. Full safety/PK data will be presented at the conference. Unlike Concert's CTP-656 phase 1 clinical trial, Galapagos chose not to use Kalydeco as a placebo comparison. The company plans to start a phase II, clinical trial for CF patients with the G155D gene mutation by the end of 2015. AbbVie and Galapagos will share responsibility and funding for phase 3 clinical development, from their agreement.
Bottom Line:
We will have to wait until the October NACFC to get a good comparison between what CTP-656, and GLPG1837 look like, as far as a PK, safety and dosing comparison is involved. Initially it looks like both drugs are safe in healthy humans, but how they interact with other drugs, and whether single or multiple dosing (b.i.d.) is required may be the differentiating factor. CTP-656 could potentially get through clinical trials quicker, if granted the expedited pathway by the FDA, and move directly to a phase 3 clinical trial after completing a phase 1. Thank you for reading.
UK Conference
CTP-656 single dose comparison with Kalydeco as placebo.
This will be the first in human clinical trial, to assess the PK, and compare against the current standard of care (Kalydeco) for CF patients. CEO Tung has already alluded to the comparison as being "significant" from a metabolic point of view. Concert will be presenting a late breaking abstract at this conference. What this means for CF patients, is that CTP-656 could potentially be dosed as a once daily, and improve on the drug to drug interaction profile over Kalydeco. We will be looking for the t1/2 life percentage improvement over Kalydeco, in addition to the AUC. The US patent extends out five years further to 2032 over Kalydeco 2027.
NACFC Conference
CTP-656 single ascending dose comparison with Kalydeco as placebo. Kalydeco is dosed 150 mg twice daily. This part of the phase 1, could tell us what an equivalent dose to 150 mg Kalydeco, could be attained with the deutered CTP-656 as single daily dosing. Following this will be a the multiple ascending dose part of the phase 1 trial, that should conclude early 2016.
GLPG1837 Galapagos (GLPG) is in a phase 1 clinical trial to assess the safety, tolerability, and the PK of potentiator GLPG1837, against placebo in healthy volunteers. From the NACFC abstract.
This randomized, double-blind, placebo-controlled study was designed to assess the safety, tolerability and pharmacokinetics of GLPG1837 in healthy volunteers over a range of single and multiple doses. In the single ascending dose (SAD) part of the study, 2 alternating cohorts of subjects are exposed to single oral doses of 30 to 2000 mg in fasted conditions (with 500 mg further evaluated after a high-fat high-calorie breakfast). The multiple ascending dose (MAD) part of the study is designed to administer GLPG1837 orally at doses of 125 to 500 mg b.i.d. for a period of 14 days. At the time of submission of this abstract the study was still ongoing. GLPG1837 has been safe and well tolerated up to the 1500 mg single dose (latest dose tested), with no dose-related abnormalities on any of the safety parameters. Full safety/PK data will be presented at the conference. Unlike Concert's CTP-656 phase 1 clinical trial, Galapagos chose not to use Kalydeco as a placebo comparison. The company plans to start a phase II, clinical trial for CF patients with the G155D gene mutation by the end of 2015. AbbVie and Galapagos will share responsibility and funding for phase 3 clinical development, from their agreement.
Bottom Line:
We will have to wait until the October NACFC to get a good comparison between what CTP-656, and GLPG1837 look like, as far as a PK, safety and dosing comparison is involved. Initially it looks like both drugs are safe in healthy humans, but how they interact with other drugs, and whether single or multiple dosing (b.i.d.) is required may be the differentiating factor. CTP-656 could potentially get through clinical trials quicker, if granted the expedited pathway by the FDA, and move directly to a phase 3 clinical trial after completing a phase 1. Thank you for reading.
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