Today’s Daily Dose brings you news about Ardelyx’ phase III study results of Tenapanor in irritable bowel syndrome with constipation; Capricor’s disappointing mid-stage trial data of CAP-1002; AstraZeneca’s encouraging results of Imfinzi in unresectable lung cancer and Ziopharm’s public offering.
Shares of Ardelyx Inc. (ARDX) plunged more than 39% on Friday, despite reporting positive results from the first of two phase III trials evaluating Tenapanor for the treatment of patients with irritable bowel syndrome with constipation, indicating investors’ skepticism.
The 12-week trial, dubbed T3MPO-1, achieved the primary endpoint of Combined Responder – i,e, a greater proportion of Tenapanor-treated patients achieved at least a 30% reduction in abdominal pain and an increase of one or more complete spontaneous bowel movements in the same week for at least 6 of the 12 weeks of treatment compared to placebo-treated patients.
The study also met seven of eight secondary endpoints.
So, what’s the worry?
The most commonly reported side effect of Tenapanor is diarrhea, and in the T3MPO-1 trial, discontinuations due to diarrhea were 5.9 percent for the Tenapanor-treated patients compared to 0.6 percent for the placebo group.
Tenapanor is also being evaluated as a treatment for hyperphosphatemia in patients with end-stage renal disease. In February of this year, the Company announced successful results from its phase III hyperphosphatemia trial. But there too, the treatment discontinuation due to diarrhea for patients treated with Tenapanor was 7.8%.
On February 2, 2015, the Company had reported results from its phase IIb hyperphosphatemia trial of Tenapanor. The trial met its primary endpoint but the stock fell as much as 32% that day as the rate of diarrhea was distinctly higher than expected in Tenapanor-treated patients.
A second phase III trial of Tenapanor for the treatment of patients with IBS-C, dubbed T3MPO-2, is ongoing with data expected early in the fourth quarter…