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AstraZeneca reports hit-and-miss PhIII for arthritis pill

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In need of late-stage success stories, AstraZeneca ($AZN) turned in another tale of mixed results from a major Phase III study of an experimental pill against rheumatoid arthritis. The London drug giant missed one out of two main goals for the study of fostamatinib, leaving the prospects of the candidate open to skepticism after it fell short of matching the efficacy of AbbVie's ($ABBV) Humira in an earlier mid-stage trial.

The lackluster data from studies of fostamatinib, a spleen tyrosine kinase inhibitor, bring more questions about the merits of an already thin late-stage pipeline from AstraZeneca. And waning expectations for the oral RA candidate punctuate the drugmaker's need for more Phase III assets to replace an aging cadre of big-market medicines such as Crestor and Nexium ahead of those drugs' upcoming patent expirations.

Yet AstraZeneca hasn't given up on fostamatinib, which the company licensed from Rigel Pharmaceuticals ($RIGL) in 2010.

In the late-stage OSKIRA-1 study, the company met the goal of improvement in a measure of joint tenderness and swelling, but then the study fell short of needed impact on bone erosion and narrowing of joint space in X-ray images. The 923-patient trial compared treatment on two doses of fostamatinib and methotrexate with placebo and methotrexate. The most common adverse events in the study included hypertension, diarrhea, nausea, headache and the common cold.

Later this fiscal quarter AstraZeneca plans to report results of the second and third Phase III studies of fostamatinib. Leerink Swann analysts say this morning that the drugmaker needs to nail down successes in two out of three of the late-stage studies to seek an approval.

AstraZeneca executives have held out hope for the program following the FDA approval of rival Pfizer's ($PFE) RA drug Xeljanz in November and intense interest in new oral attacks on rheumatoid arthritis, which is dominated by multibillion-dollar sales of injected therapies such as Humira and Enbrel.

"These top-line results provide important information on the efficacy and safety of fostamatinib and demonstrate that the compound has an effect on the signs and symptoms of rheumatoid arthritis," Dr. Briggs W. Morrison, AstraZeneca's executive vice president of global medicines development and medical chief, said.

AstraZeneca's new CEO Pascal Soriot, recruited from Roche, has made clear that he wants to improve the company's lackluster R&D track record. Last month the CEO revealed a reorganization of his global research group with 1,600 jobs to be cut and after he quick-marched former R&D chief Martin Mackay to the exits.

- here's the release
- see the Reuters article
- and TheStreet's report

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