Results

Pushing the positive in p=0.05, RedHill says it’s ready for a pivotal IBD test

June Almenoff

RedHill BioPharma $RDHL pushed hard to tout the data from a Phase II study for irritable bowel disease, but the stock started to slide this morning as the online gambling crowd started to tease out the meaning of the p=0.05 bottom line that came with the data.

That’s right on the border of victory and defeat in a clinical study, and not all observers were ready to cheer the data alongside Redhill execs.

Investigators tested a 12mg dose of Bekinda (RHB-102) among 126 patients with diarrhea predominant IBD. Using FDA guidance, they used a primary efficacy outcome of stool consistency response.

In the drug arm 54.7% of the patients responded, compared to 35.3% in the placebo group, though the company insisted that the near-20 point difference compared favorably with what researchers saw in late-stage studies of Xifaxan and Viberzi. (We’ll note here that researchers generally hate to compare data from different trials using different patient populations, etc. — unless it backs up their case.)

The data also looked fairly unimpressive to the skeptics in Twitter, though, which did nothing for its share price, which dropped about 8% in early trading.

“If both the safety and efficacy results are reproduced in the planned pivotal studies, possibly powered to win on pain as well, Bekinda 12 mg has the potential, if approved, to become an important new therapy and standard-of-care for IBS-D,” noted advisory board member June Almenoff.


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