Global Blood Therapeutics (GBT) has decided to terminate the GBT440 program for the treatment of idiopathic pulmonary fibrosis (IPF).
The company has taken the decision based on three proof-of-concept studies, which does not show clinically meaningful efficacy results.
The studies comprised of Phase 1 study in healthy volunteers called Basecamp and two Phase 2a studies in patients with IPF called GBT440-006 and ZEPHYR.
In Basecamp, the healthy volunteers who secured GBT440 900mg under hypoxic conditions showed a statistically significant increase in oxygen saturation, validating the mechanism of action of the drug in hypoxemia and showing that GBT440 is a potent and effective hemoglobin modifier.
In GBT440-006, the adults with IPF and low oxygen levels during exercise who secured GBT440 1,500mg showed a statistically significant but small dose-dependent improvement in oxygen-saturation.
In ZEPHYR, the adults with more severe IPF (on oxygen at rest) who secured GBT440 900mg did not show improvement in oxygen saturation.
According to the company, the studies show proof-of-concept regarding improvement in oxygen saturation in healthy volunteers and patients with IPF.
GBT president and CEO Dr Ted Love said: “From the outset, we set a high bar for success in our IPF program. The results re-affirm our confidence in the mechanism of action of GBT440.
“However, the data from these proof-of-concept studies did not demonstrate sufficient overall clinical benefit to justify continuing the program.
“While we are disappointed that we didn’t meet our high bar for success, and we are disappointed that we will not be able to help the IPF community, we are grateful to the patients, healthy volunteers and healthcare professionals who participated in the trials and supported us in these efforts.”