AbbVie recently provided its 2Q17 update in a call led by CEO Mr. Richard Gonzales. As usual, there was no mention of phase 3 diabetic nephropathy candidate atrasentan (an endothelin A antagonist), nor did we hear any commentary on NASH. This latter piece was somewhat disappointing, considering management’s suggestion on the company’s 1Q17 call that NASH was “on the roadmap” for AbbVie going forward. Of course, this doesn’t necessarily imply anything about the company’s plans to invest in NASH, and we’ll be watching closely for any new NASH candidates that pop up in AbbVie’s pipeline (this is an area of high unmet need, and a common comorbidity of type 2 diabetes). According to ClinicalTrials.gov, the phase 3 SONAR trial of atrasentan is expected to complete in April 2020. In 1Q17, we noticed that this timing was pushed back from the previous November 2018, though this wasn’t particularly surprising given that recruitment for the study began in May 2013 and is still ongoing. Atrasentan used to be the leading candidate in the diabetic nephropathy competitive landscape, but these recruitment woes and trial delays have put its clinical progress behind other agents in phase 3: The DERIVE trial for AZ’s SGLT-2 inhibitor Farxiga (dapagliflozin) is expected to complete in November 2017, the CREDENCE trial for J&J’s SGLT-2 inhibitor Invokana (canagliflozin) is expected to complete in June 2019, a phase 3 study of allopurinol (sponsored by JDRF, NIH, and other collaborators) is also expected to complete in June 2019, and phase 3 trials of Bayer’s finerenone are expected to complete in October 2019 and February 2020. Our diabetic nephropathy competitive landscape offers a more complete picture, including details on earlier-stage pipeline products aiming for this indication.
-- by Payal Marathe and Kelly Close