Date: 2013-12-13
Type of information:
phase: 3
Announcement: results
Company: AstraZeneca (UK)
Product: lesinurad
Action mechanism: Lesinurad is an investigational agent being studied as a selective uric acid re-absorption inhibitor (SURI) that inhibits the URAT1 transporter, normalising uric acid excretion and reducing serum uric acid (sUA).
Disease: gout
Therapeutic area: Inflammatory diseases
Country:
Trial details: LIGHT (Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors) was a six month study conducted by AstraZeneca and Ardea Biosciences, a wholly-owned subsidiary of AstraZeneca, to assess the sUA lowering effects and safety of 400mg of lesinurad used once daily as a monotherapy compared to placebo in 214 patients with sUA levels ? 6.5 mg/dL (highly symptomatic population with mean sUA of 9.3mg/dL at baseline) who are intolerant, or have a contraindication, to allopurinol or febuxostat.
Latest
news: * On December 13, 2013, AstraZeneca has announced top-line results from LIGHT, a Phase III study investigating the potential of lesinurad as a monotherapy in the small population of gout patients who are intolerant to, or otherwise cannot take, one or both xanthine oxidase inhibitors allopurinol and febuxostat. In the trial, lesinurad met the primary endpoint with a statistically significant (p< 0.0001) higher proportion of patients meeting the sUA goal of <6.0 mg/dL at six months compared with those patients treated with placebo. Patients in the LIGHT study treated with lesinurad monotherapy were more likely to experience serum creatinine elevations and renal adverse events, including serious events, compared to patients on placebo. Other commonly reported adverse events in patients treated with lesinurad monotherapy were diarrhoea, nausea and constipation.
The other Phase III trials in the lesinurad programme are investigating lesinurad in combination with allopurinol in patients not reaching target sUA levels on allopurinol alone (CLEAR1 and CLEAR2) and as a combination therapy with febuxostat in patients with tophaceous gout (CRYSTAL). The results of these studies are expected in mid 2014, and regulatory submissions in the US (NDA) and EU (MAA) are expected in the second half of 2014.
