Galecto was advised to stop enrolling and treating patients at high dose and certain ones at low dose in its Phase 2b GALACTIC-1 trial of GB0139, an investigational inhaled therapy for idiopathic pulmonary fibrosis (IPF).
The recommendation — made by an independent data safety and monitoring board (DSMB) that recently conducted a safety analysis of the trial’s current data — specifically concerned people randomized to either the 10 mg dose of GB0139, or to the 3 mg dose when given in combination with other IPF standard-of-care therapies, such as Ofev (nintedanib) and Esbriet (pirfenidone).
After a review of unblinded safety and efficacy data from the GALACTIC-1 (NCT03832946) trial, the DSMB noticed an “imbalance in serious adverse experiences across study groups,” the company said in a press release, without further explanation. No such imbalance was seen in mortality.
The DSMB recommended that patients in both these groups — high dose and combination low dose — discontinue treatment and leave the trial.
Galecto said it is working with study investigators and regulatory authorities to implement these changes.
“Galecto is committed to patient safety and continuing the development of life changing treatments for patients with IPF,” said Hans Schambye, MD, PhD, CEO of Galecto.
The company expects to continue enrolling IPF patients not using Ofev or Esbriet, who will be randomized to GB0139 at a 3 mg dose or to a placebo, given as a dry powder inhalation once daily. Recruitment is currently underway at multiple sites in the U.S., the European Union, Canada, the U.K., and Israel.
“Around 50% of IPF patients in Europe and the U.S. do not receive treatment with either pirfenidone or nintedanib, representing a very significant unmet medical need, as they have no available treatment options. Based on our prior phase 1b/2a study of GB0139 in IPF patients, we believe the 3 mg dose has the potential to be an effective clinical dose for these patients,” Schambye said.
“There is a very strong demand for a tolerable alternative to the approved therapies,” he added. “We anticipate completing enrollment in the GALACTIC-1 trial this year with initial data readout in 2022.”
GALACTIC-1, a 52-week study, will continue to evaluate the safety and efficacy of GB0139 in IPF patients, as a low-dose inhalation treatment and not in combination with other IPF therapies. The trial initially aimed to enroll about 450 patients, ages 40 and older, and no changes are expected here.
The trial’s main goal is to assess treatment effects on forced vital capacity (FVC), a standard lung function measure, at the study’s end. Secondary goals include the proportion of participants whose FVC declines by more than 10% from the study’s start, as well as the time to IPF-related hospitalization or mortality.
“We do not expect the recommended changes, which relate solely to the inhaled GB0139 in IPF, to impact any of our other planned trials,” Schambye said, adding that three additional Phase 2 trials of GB2064 and GB1211 — two oral experimental therapies for other fibrotic disorders — are planned to start this year.
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