Gilead Sciences said it is halting a combined Phase II/III trial assessing its anti-MMP9 antibody candidate GS-5745 in patients with moderately to severely active ulcerative colitis.
The halt, Gilead said yesterday, followed a recommendation from the trial’s Data Monitoring Committee that the study be terminated early for failing to meet prespecified futility and efficacy criteria.
The committee carried out a planned interim analysis after the first 150 patients were treated for an 8-week induction duration in the planned 1600-patient trial.
The proportion of participants in a cohort of patients achieving remission at week 8 based on select Mayo Clinic Score (MCS) measures was one of the trial’s two primary endpoints. The other was the proportion of participants in a second cohort achieving remission at week 52 based on select MCS measures.
“Gilead has also reviewed the data and determined that there is insufficient evidence of a treatment benefit in the group of patients randomized to receive either one of two doses of GS-5745,” Gilead said in a statement.
The interim analysis included no safety concerns, Gilead added.
The trial began in September 2015, and had a primary completion date of February 2019, according to ClinicalTrials.gov.
“The discontinuation of the development of GS-5745 for ulcerative colitis is disappointing. This is the latest in the series of pipeline setbacks faced by Gilead,” Zacks Equity Research concluded today on its Analyst Blog.
Zacks cited Gilead’s termination in January of a Phase II study assessing simtuzumab idiopathic pulmonary fibrosis, citing a lack of efficacy. Simtuzumab remains in Phase II development for nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis.
In March, Gilead halted six trials of Zydelig (idelalisib) in combination with other treatments in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, and indolent non-Hodgkin lymphomas, following reports of deaths and other adverse effects. The drug is approved, however, in three other cancer indications: chronic lymphocytic leukemia (CLL), follicular B-cell non-Hodgkin lymphoma, and small lymphocytic lymphoma.
Gilead said the trial halt will not affect other clinical studies of GS-5745. According to the company, GS-5745 is the subject of an ongoing Phase III study in patients with gastric cancer, a Phase II study assessing the compound in combination with Bristol-Myers Squibb’s Opdivo® (nivolumab) in patients with gastric cancer; and additional Phase II studies in moderately to severely active Crohn’s disease, rheumatoid arthritis and cystic fibrosis.
“These studies will continue as planned,” Gilead added.