Date: 2016-06-20
Type of information: Initiation of the trial
phase: 2a
Announcement: initiation of the trial
Company: Global Blood Therapeutics (USA - CA)
Product: GBT440
Action
mechanism: Hypoxemia (abnormally low levels of oxygen in the blood) can lead to tissue hypoxia (a deficiency in the amount of oxygen reaching the tissues), which is believed to play a key role in adverse patient outcomes in idiopathic pulmonary fibrosis. GBT440, a hemoglobin modifier, works by increasing hemoglobin's affinity for oxygen. Emerging data suggest that hemoglobin modifiers such as GBT440 have the potential to restore normal hemoglobin function and increase oxygen uptake in the lungs, resulting in improved oxygen delivery to tissues. GBT440 has been shown in preclinical studies to increase oxygen saturation in hypoxic conditions.
Disease: idiopathic pulmonary fibrosis and hypoxemia
Therapeutic area: Lung diseases - Respiratory diseases - Rare diseases
Country:
Trial details:
Latest
news: * On June 20, 2016, Global Blood Therapeutics, announced it has initiated a Phase 2a study of GBT440, a hemoglobin modifier, in adults with idiopathic pulmonary fibrosis (IPF) and hypoxemia. GBT440-006 is a randomized, double-blind, placebo-controlled study of GBT440 that is evaluating safety, tolerability, pharmacokinetics and effect on hypoxemia in patients with IPF. A total of 18 IPF patients will be enrolled and randomized to one of two doses of GBT440 or placebo administered orally once daily for 28 days. An additional 12 patients may be enrolled following an independent safety review for a total of up to 30 patients. In addition to safety, tolerability and pharmacokinetics of GBT440, the change from baseline in oxygen saturation both at rest and after exercise will be explored.
