Positive Results on SGYP Candidate - Analyst Blog
January 03 2013 - 11:30AM
Zacks
Synergy Pharmaceuticals (SGYP) recently
presented positive results from a phase IIb/III study on its
chronic idiopathic constipation (CIC) candidate, plecanatide. The
study met its primary objective along with other key
objectives.
The results also showed that plecanatide was well tolerated.
Synergy Pharma enrolled 951 patients suffering from CIC across 113
clinical sites in the US for the phase IIb/III study.
The study was designed to evaluate plecanatide (0.3, 1.0, 3.0 mg
doses) in increasing the number of complete spontaneous bowel
movements (CSBM's) along with the impact of other parameters in CIC
patients. The study showed that the 3mg dose of the candidate
demonstrated a 19% (p=0.009) overall responder rate compared to
10.7% in placebo.
We remind investors that the CIC market is highly competitive
with the presence of players like Forest Laboratories
Inc. (FRX) and Ironwood Pharmaceuticals
(IRWD).
We note that last week Synergy Pharma initiated a phase IIb
study with plecanatide for the treatment of patients suffering from
constipation-predominant irritable bowel syndrome (IBS-C). The
trial will be evaluating the average change in CSBMs during the
trial period in comparison to their baseline weekly CSBM rate that
was established during the screening phase of the study.
Additionally, Synergy Pharma recently completed a phase I
clinical trial on SP-333, a guanylate cyclase C (GC-C) agonist,
being developed for the treatment of ulcerative colitis (UC) and
other GI diseases.
We expect investor focus to stay on the successful development
of the candidate. Synergy Pharma currently carries a Zacks #3 Rank
(Hold). Meanwhile, Ironwood Pharma carries a Zacks #1 Rank (Strong
Buy).
FOREST LABS A (FRX): Free Stock Analysis Report
IRONWOOD PHARMA (IRWD): Free Stock Analysis Report
SYNERGY PHARMAC (SGYP): Free Stock Analysis Report
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