October 1, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Wall Street analysts are bullish on Ardelyx Inc. , a clinical-stage biopharmaceutical company, after it released positive phase 2 data for its novel gastrointestinal drug Tenanpanor in the treatment of irritable bowel syndrome, two biotech analysts with Citigroup said Wednesday.
“We believe the data looks competitive to leading approved drugs in this setting, and we will await plans from partner AZN in this setting,” wrote analyst Jonathan Eckard and Yaron Werber in a note to investors.
Citigroup does not include IBS-C in their estimates to reach its current price of $27, and therefore the drug could present an upside to estimates if the path forward for the drug were to become more clear.
“We also remain positive on Tenapanor’s profile and current data in chronic kidney disease (CKD) and end-stage renal disease (ESRD), with important phase 2 data expected during 2015,” they wrote.
Citi maintained its buy rating on the stock.
The phase 2b trial enrolled 371 IBS-C patients into three doses of Tenapanor, showing a dose-response, and the highest (50 mg bid) showed highly statistically significant benefits. In this 50mg dose, 61 percent hit the primary endpoint versus 34 percent for placebo. The secondary dual composite endpoint of complete spontaneous bowel movements and abdominal pain responder in 6 of 12 weeks was also highly positive with 50 percent Tenapanor versus 24 percent for placebo meeting response criteria.
“Importantly, the secondary composite endpoint ARDX used in this trial is outlined in FDA guidance as the approval endpoint for IBS-C. We believe the similarities on the measure for Tenapanor and currently approved drugs should ease AZN’s assessment of Tenapanor and the IBS-C landscape,” wrote Eckhard and Werber. “We also believe these results point to a competitive profile for Tenapanor in this setting on both efficacy and safety, and could be difficult for AstraZeneca PLC to ignore.”
