People with idiopathic pulmonary fibrosis (IPF) who have low levels of oxygen in the blood (hypoxemia) might be closer to having a new treatment option with the launch of a Phase 1 trial evaluating GBT440 in healthy volunteers, and two Phase 2 tests in select IPF patients.
Global Blood Therapeutics developed GBT440 as a hemoglobin modifier that transforms the oxygen-hemoglobin dynamic, potentially increasing oxygen uptake in the lungs and improving blood oxygen saturation, as well as oxygen delivery to heart and lung tissue.
“In patients with chronic hypoxemic pulmonary disorders such as IPF, the lungs cannot supply adequate oxygen to the blood, and the resulting hypoxia is believed to play a key role in adverse outcomes,” Ted W. Love, MD, president and CEO of Global Blood Therapeutics, said in a press release.
The Basecamp trial (NCT03051711) will assess the drug’s safety, tolerability, pharmacokinetics and effect in healthy volunteers under hypoxic and exercise conditions that maximize stress of the heart and lungs.
About 12 healthy volunteers between 18 and 50 years old will be enrolled in the study, and will receive 900 mg of GBT440 administered orally, once a day, for 14 days. The study’s primary endpoint is the change in oxygen saturation at rest and during maximal exercise, measured under hypoxic conditions. Assessment of VO2-max, cardiac output and dyspnea (difficulty breathing) is included in the study’s secondary endpoints.
Researchers will assess both primary and secondary endpoints at rest and after maximal exercise under normoxic (normal levels of oxygen) and hypoxic conditions.
Global Blood Therapeutics is also conducting two Phase 2 trials evaluating GBT440 as a potential treatment for hypoxemia in two specific groups of IPF patients: patients who become hypoxemic on exertion (NCT02846324), and patients who depend on oxygen at rest (NCT02989168). Both trials are currently recruiting IPF patients at numerous sites in the U.S. (information is available on the links provided).
“We believe GBT440 has promising applications in hypoxemic pulmonary conditions because of its potential to enable increased oxygen uptake in the lungs and improve oxygen saturation, which in turn improves oxygen delivery to tissues,” Love said. “Designed to address the physiologic effects of GBT440 under hypoxemic and maximal stress conditions in fit healthy volunteers, Basecamp results will support our understanding of GBT440’s effects on hypoxemia and exercise capacity across a range of hypoxic conditions.”