- AstraZeneca halted a Phase 2a trial for an asthma drug licensed from U.K.-based Synairgen after an interim analysis revealed a lower-than-expected number of exacerbations would likely make it difficult to determine primary efficacy results, Synairgen reported on Wednesday.
- Synairgen said AstraZeneca would continue to evaluate secondary endpoints for the drug, an inhaled form of interferon beta, with more detailed data expected in the first quarter of 2017.
- The trial setback is still a major blow to Synairgen and its lead program, however. Company shares fell sharply in value on the London Stock Exchange Wednesday.
Synairgen licensed the drug in question (SNG001 or AZD9412) to AstraZeneca in June 2014, receiving $7.25 million upfront with potential for up to another $225 million in milestone payments.
At the time, AstraZeneca saw the inhaled interferon beta candidate as a good complement to its respiratory portfolio, with potential in both severe asthma and chronic obstructive pulmonary disease (COPD).
In addition to the Phase 2a study that was halted, AstraZeneca is also working with Synairgen on a Phase 1 study in COPD.
Unfortunately for Synairgen, however, the number of severe exacerbations seen in the trial population were lower than what the companies expected based on the original trial design. With fewer events to measure, AstraZeneca concluded it would be difficult to analyze whether the study met its primary endpoint.
Synairgen did say AstraZeneca believed there were a sufficient number of patients to evaluate secondary endpoints.
Synairgen doesn't have a deep bench of other candidates in development. Outside of SNG011, Synairgen is partnered with Pharmaxis to develop a LOXL2 inhibitor currently in discovery phase. Phase 1 clinical trials on that drug are expected to begin sometime in 2017, according to a recent earnings report.