With Latest Data, Investors Again Compare Synergy To The Billion-Dollar Ironwood Pharma

Synergy Pharmaceuticals (SGYP) is getting some much-needed love with phase 2 data, presented at a medical meeting on Monday, for the company's lead drug candidate, plecanatide in Irritable Bowel Syndrome (IBS-C). Plecanatide is already in phase 3 trials for the treatment of Chronic Constipation, and a large phase 3 IBS-C program is set to start by the end of 2014, according to the company.

Synergy presented detailed results from the phase 2b plecanatide IBS-C trial at the American College of Gastroenterology’s 2014 Annual Scientific Meeting on Monday. The company released top-line results in April of this year, but this is the first detailed look at the data.

Investors like to compare developmental drugs to existing/competing products in order to gauge potential. Ironwood Pharmaceuticals (IRWD) and partner Forest Labs, of Actavis (ACT), are already on the market with a similar product called Linzess. Both drugs are guanylate cyclase-C agonists, though Synergy's product may have some tolerability improvements. Analysts project peak Linzess sales of over $1 billion dollars. Lionesses did $62.7 million in the second quarter of 2014.

Two data points of note with the latest data, available here:

The trial demonstrated that 41.9% and 40% of patients receiving 3mg and 9mgs of plecanatide, respectively, were Overall Responders under FDA criteria. Only 24.7% of patients receiving placebo (p<0.05) met this criteria.

Under the FDA's definition of an Overall Responder, a patient must show a ≥30% reduction in worst abdominal pain and an increase of ≥1 complete spontaneous bowel movements (CSBMs) from baseline in the same week, for at least 6 of 12 weeks.

This also compares favorably to about 34% of patients responding to Linzess in Ironwood's phase 3 trials.

Plecanatide's key differentiating feature when compared to Linzess is a lower rate of diarrhea. In this IBS-C trial, and consistent with previous constipation trials, around 10% of patients presented with diarrhea; twice that, about 20%, of patients taking Linzess present with diarrhea.

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