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Synergy Pharma preps step 2 for Trulance as positive PhIII IBS-C data squares off against Ironwood and Ardelyx

Gary Jacob, Synergy CEO

Hot on the heels for an approval of Trulance (plecanatide) for chronic idiopathic constipation, Synergy Pharma $SGYP is back with positive Phase III data on irritable bowel syndrome, which will quickly trigger some comparisons with a well-established drug in the market as well as a late-stage drug coming up close behind.

Investigators say that Trulance scored the primary endpoint in two large studies involving 2,100 patients with IBS involving constipation. Overall responders — those patients who achieved a significant reduction in the worst abdominal pain along with a significant increase in bowel movements over 6 of 12 weeks — in both dose groups outpaced the placebo arm.

By the numbers:

Study 1: 30.2% in 3 mg and 29.5% in 6 mg dose groups compared to 17.8% in placebo; p<0.001 for 3 mg and p<0.001 for 6 mg; Study 2: 21.5% in 3 mg and 24.0% in 6 mg dose groups compared to 14.2% in placebo; p=0.009 for 3 mg and p<0.001 for 6 mg).

The efficacy tallies, though, trail a bit behind Ironwood’s $IRWD Linzess, approved back in 2012. At the time the FDA highlighted this set of data: In 6 out of 12 weeks, 34% (Study 1) and 34% (Study 2) of LINZESS-treated patients were combined responders, versus 21% (Study 1) and 14% (Study 2) of placebo-treated patients. However, the most common adverse event that investigators were watching out for, diarrhea, was lower among the Trulance patients.

Unless you run a head-to-head study, cautioned Trulance investigator Ronald Fogel, you’re not really going to find out which drug is actually better. A few points one way or the other could be explained by various factors. Fogel, who also treats patients in his Michigan clinic, says it may not matter much in any case. He and other physicians in this field prefer to let patients take home a couple of drugs available for this condition to find out which one is right for them. That n=1 approach always works best, he adds, especially when you consider that most patients don’t respond as desired to any one therapy.

“We give patients samples of each one and say, tell me which is best and we’ll give you a prescription,” Fogel tells me. “I think it will be a mix. You never really know how people will respond. Sometimes nothing works.”

He and his colleagues may also have another drug to add to that sample mix.

Ardelyx $ARDX is being given good odds as analysts wait for their Phase III IBS-C data on pain and bowel movements and diarrhea for tenapanor. The first round of Phase III data comes later in this quarter, with Wedbush looking for an NDA filing in 2018.


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