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Synergy Hits Mark on Second Trial, Eyes Approval For Constipation Drug

Xconomy New York — 

It looks like Synergy Pharmaceuticals may have a drug on its hands.

Shares of the New York-based company surged over 15 percent in pre-market trading this morning after its drug for chronic idiopathic constipation (CIC), plecanatide, hit all of its goals in the second of two Phase 3 trials. As with an earlier study in June, plecanatide was better than a placebo at alleviating patients’ chronic constipation over 12 weeks. The results help position Synergy to file an application for approval of the drug with the FDA in January of next year, the company said.

It’s tricky to compare across trials, of course, but what has Synergy (NASDAQ: SGYP) surging is the implication that plecanatide, a once-daily pill, may be easier to tolerate—namely, lead to less diarrhea—than a rival, marketed drug from Ironwood Pharmaceuticals called linaclotide (Linzess). In the latest study, 3.2 percent of patients on a 3.0 mg dose and 4.5 percent of patients on a 6.0 mg dose reported diarrhea, compared to 1.2 percent of those on placebo. (Linaclotide’s label lists that diarrhea occurred in 16 percent of patients with chronic constipation in a Phase 3 trial.)

At the same time, patients had a “durable overall response” to the drug—as in, to be crude, they pooped more times per week than those on placebo. Some 20.1 percent of the patients taking 3 mg of the drug and 20.0 percent of the patients taking 6 mg responded, compared to 12.8 percent of patients on placebo. Synergy enrolled 1,337 patients in the study; around 440 patients were in each study arm. The numbers are similar to those Synergy reported from its first study (21 and 19.5 percent responders, respectively, in the 3.0 mg and 6.0 mg groups compared to 10.2 percent in placebo; diarrhea in 5.9 and 5.5 percent of the 3.0 mg and 6.0 mg groups).

Synergy will disclose more data from its two studies at upcoming scientific conferences.

Synergy’s drug is one that, like Ironwood’s (NASDAQ: IRWD), is a so-called “guanylate cyclase” receptor agonist—it binds to a specific target found on the lining of the gut, which is supposed to boost the secretion of fluids in the intestines, and help stool pass through. Plecanatide mimics the activity of a naturally occurring hormone, uroguanylin. Ironwood and Synergy had a patent feud surrounding plecanatide a few years ago, but came to a deal in 2012 whereby Ironwood could get a “low single digit” royalty on net sales of Synergy’s drug. (Synergy reserves the right in the deal to challenge certain Ironwood patents in the future.)

Plecanatide is also in a mid-stage trial for irritable bowel syndrome with constipation, another disease for which linaclotide is already approved.

Photo “In the Stomach” courtesy of Marcin Chady via a Creative Commons license.