Dive Brief:
- Before market open on Wednesday, British drugmaker AstraZeneca plc disclosed its once-failed asthma drug has chalked up two more late-stage failures.
- The treatment, called tralokinumab, did not meet its primary endpoint in both the Phase 3 TROPOS study, and the late-stage STRATOS 2 trial. Topline results showed the drug failed to significantly reduce asthma exacerbation rates or lessen the need for steroid use in severe asthma patients.
- These setbacks come several months after the interleukin-13 inhibitor failed the STRATOS 1 study this past May.
Dive Insight:
The two latest failures for tralokinumab should probably not have come as a surprise. The drug's miss in its first Phase 3 study forced AstraZeneca to switch gears mid-stream.
After the iffy data from STRATOS 1, the British pharma emphasized a sub-population of the study with high levels of a certain biomarker that had responded well to the drug, despite the overall failure. This prompted AstraZeneca to emphasize these likely responders in the already-ongoing STRATOS 2 study.
Yet despite the narrowed focus on a patient subgroup, STRATOS 2 came up short. AstraZeneca has not yet revealed the underlying data from these studies, but expects to present them at an upcoming medical meeting.
This will likely be AstraZeneca's last attempt to push forward with this product. In its ongoing sell off of non-core assets, the drugmaker divested the rights to tralokinumab in skin disorders to Leo Pharma for $115 million upfront in a deal that could be worth $1 billion should tralokinumab ever make it to market.
The sale was part of a yearslong effort by AstraZeneca to focus on core therapeutic areas and monetize any products that don't fit into those niches. The company has had a laundry list of deal announcements over the last two years as it sells off segments of its portfolio product by product.
But tralokinumab isn't the only IL-13 blocker experiencing problems. Swiss pharma giant Roche had a similar compound in its development pipeline that it sold to Dermira last year for $80 million upfront and another $1.84 billion in milestones after mixed late-stage results.