Based on the safety, tolerability and pharmacokinetic data from this study, the company plans to advance VX-814 into a Phase 2
dose-ranging study in patients with two Z mutations.
The Phase 2 study is expected to be initiated in the third quarter of 2019 and will be a randomized, placebo-controlled,
dose-ranging study that will enroll approximately 100 patients at 60 sites globally.
Ferrannini said, as shown in a 2010
dose-ranging study he led.
The phase II safety, efficacy, and
dose-ranging study of 245 patients (231 in the modified intent-to-treat population, and 237 in the safety population) also compared 2.8- and 5.6-mg sublingual doses.
Tiotropium Respimat in asthma: a double-blind, randomized,
dose-ranging study in adult patients with moderate asthma.
Separately, Gary Hattersley, Ph.D., presented encouraging results from a 231-patient, 24-week, phase II
dose-ranging study of abaloparatide delivered by transdermal patch.
The company shares had lost 5.74 percent in regular trading Friday after it announced it had voluntarily discontinued its Phase 2b
dose-ranging study of MDCO-2010, a serine protease inhibitor which was being developed to reduce blood loss during surgery.
Robust efficacy was demonstrated in both 1% and 4% strength doses in this randomized, double-blind,
dose-ranging study enrolling 32 patients ages 2 to 15.
Based on positive results from a phase I/II study with ofatumumab in multiple sclerosis (MS) announced earlier this month, GSK plans to start a phase IIb
dose-ranging study in MS with subcutaneous delivery in 2011.
The phase 2b
dose-ranging study evaluated the efficacy, safety and tolerability of GSK1838262 in adults diagnosed with migraine headache (with or without aura), according to the International Headache Society criteria.
In their extension of a 28-week Phase II
dose-ranging study, Takeda and Amylin note that patients who continued treatment with pramlintide/metreleptin for 52 weeks demonstrated sustained weight loss, whereas those continuing on a placebo regained almost all of their weight.
Sanofi-aventis recently announced that the results of the TREK
dose-ranging study for its new injectable anticoagulant, AVE5026, were presented at the 49th annual meeting of the American Society of Haematology (ASH) in Atlanta.