Biotech Values

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Synergy Pharmaceuticals Announces Positive Results in the Second Phase 3 Trial of Plecanatide in Patients with Chronic Idiopathic Constipation (CIC)

Preliminary analysis of the data indicates that both plecanatide 3.0 mg and 6.0 mg doses met the study’s primary endpoint and demonstrated statistical significance in the proportion of patients in the intention-to-treat population who were durable overall responders compared to placebo during the 12-week treatment period (20.1% in 3.0 mg and 20.0% in 6.0 mg dose groups compared to 12.8% in placebo; p=0.004 for both doses). The durable overall responder endpoint is the current FDA endpoint required for US approval in CIC. Importantly, plecanatide was safe and well tolerated at both doses; the most common adverse event was diarrhea, which occurred in 3.2% of patients in 3.0 mg and 4.5% of patients in 6.0 mg dose groups compared to 1.3% of placebo-treated patients.

http://finance.yahoo.com/news/synergy-pharmaceuticals-announces-positive-results-100000891.html?soc_src=mediacontentstory&soc_trk=tw