- Gilead on Wednesday said it will end a Phase 2/3 study testing its experimental anti-MMP9 antibody in ulcerative colitis, citing insufficient evidence of benefit after a planned interim analysis of unblinded data.
- A data monitoring committee recommended the study be terminated after reviewing safety and efficacy results from the first 150 patients after eight weeks of treatment.
- Gilead had planned to enroll 1600 participants in the trial, which was one of five studies testing the drug, known as GS-5745, in various diseases.
Gilead will continue studying GS-5745 in other indications, so the setback in ulcerative colitis doesn't mean a total scrap of the program. But given the California drugmaker's reliance on revenue from its hepatitis and HIV drugs, any pipeline miss is met with questions of whether Gilead can be successful without external acquisitions.
A Phase 3 study in gastric cancer which combines GS-5745 with Bristol-Myers Squibb's Opdivo is the most advanced of the remaining studies. Gilead is also testing the drug in a mid-stage study in moderate-to-severe Crohn's disease, along with two early trials in solid tumors and rheumatoid arthritis.
"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," the company said.
Notably, Gilead did not indicate any new safety concerns with GS-5745.
With revenue from top-selling Harvoni falling sharply in the U.S., Gilead is under renewed pressure to deploy its roughly $25 billion in cash (as of June 30). Execs have previously said all options are on the table for future M&A, although Chief Operating Officer Kevin Young suggested at a recent investor conference that Gilead might be eyeing more medium and small-sized acquisitions.
At the same time, external events have made Gilead's pipeline look more attractive. Allergan's big push into the NASH space this week made Gilead's April acquisition of Nimbus Therapeutics and its mid-stage NASH therapy look more prescient.
Since Allergan announced its purchase of Tobira Therapeutics on Tuesday morning, Gilead stock has risen 3.2% through Wednesday's close (compared to Monday's closing price).
Still, investors may look with some skepticism on Gilead's non-liver disease, non-HIV forays until the company can prove it can develop a hit outside those areas. This fall should answer some of those questions, with a number of expected trial read-outs.
"Despite 5745’s failure in [ulcerative colitis], we continue to believe expectations are low for GILD’s overall pipeline, and though they come with mixed levels of risk, we can expect to see many other pipeline data points reading out over the coming months," wrote Jeffries analyst Brian Abrahams in a note.