AstraZeneca (AZN) announced top-line results from the phase III LIGHT study (n=214) on lesinurad. The phase III study is evaluating the potential of lesinurad as a monotherapy in gout patients who were unsuccessfully treated with one or both xanthine oxidase inhibitors, Zyloprim (allopurinol) and Uloric (febuxostat).
AstraZeneca is evaluating the candidate as a selective uric acid re-absorption inhibitor (:SURI) that inhibits the URAT1 transporter to normalize uric acid excretion and reduce serum uric acid (sUA) levels. Results from the study revealed that the proportion of patients under lesinurad met the sUA goal (<6.0 mg/dL) at six months compared to patients under placebo.
AstraZeneca further mentioned that patients under lesinurad, as monotherapy, experienced serum creatinine elevations and renal adverse events compared to those under placebo. Some of the common adverse events experienced by the patients under lesinurad monotherapy are diarrhoea, nausea and constipation.
We note that lesinurad is also being developed in three other late-stage studies (CLEAR1, CLEAR2 and CRYSTAL) in combination with xanthine oxidase inhibitors for the treatment of patients suffering from tophaceous gout. AstraZeneca expects results from these studies in mid 2014.
The company plans to make regulatory submissions for lesinurad in both the U.S. and EU during the second half of next year. We remind investors that lesinurad was added to AstraZeneca’s pipeline with the acquisition of Ardea Biosciences, Inc. In Jun 2012, AstraZeneca completed the acquisition of Ardea Biosciences for approximately $1.26 billion or $32 per share. We expect investor focus to remain on AstraZeneca’s pipeline going forward.
AstraZeneca presently carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Jazz Pharmaceuticals (JAZZ), Bayer (BAYRY) and Johnson & Johnson (JNJ). While Jazz Pharma holds a Zacks Rank #1 (Strong Buy), Bayer and Johnson & Johnson carry a Zacks Rank #2 (Buy).