- AstraZeneca's lupus drug failed to reduce the disease's activity in a pivotal clinical trial, according to a Friday announcement.
- The British pharma did not release any data in its topline report beyond the fact that the study did not achieve its primary endpoint of reducing the activity levels of systemic lupus erythematosus (SLE) in patients with moderate to severe forms of the autoimmune disease.
- Sean Bohen, AstraZeneca's chief medical officer, called the trial results "disappointing for patients and the lupus community" in an Aug. 31 statement.
AstraZeneca hoped anifrolumab could work for lupus, a disease that has been particularly difficult for pharmas to find effective treatments for in recent years.
This spring, two other companies flopped in the space. Ablynx NV failed a Phase 2 trial in March, jeopardizing a deal with AbbVie that could be worth as much as $665 million. Then, ImmuPharma's lupus drug missed the mark in a pivotal study in April, leading the company's stock to plummet as a result.
AstraZeneca's drug fared well in Phase 2 testing, where results showed it significantly reduced disease activity and improved common symptoms of lupus such as rash and arthritis.
That promise faltered in TULIP 1, the first of two Phase 3 trials for anifrolumab.
TULIP 1 enrolled 460 patients who every four weeks received either placebo or intravenous infusions of anifrolumab at a 150 mg dose or a 300 mg dose. anifrolumab every four weeks as well as placebo. But it failed to meet its goal of providing a statistically-significant reduction in disease as measured by the SLE Responder Index 4 at 12 months. Full results will be revealed at a future medical meeting.
The second trial, TULIP 2, pits a fixed dose of 300 mg of anifrolumab every four weeks against placebo for 373 patients. Topline results are expected later this year, according to the company.
AstraZeneca previously planned to file anifrolumab for approval in 2019 for the U.S., Europe and Japan.