) 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
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.
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
FOREST LABS A (FRX): Free Stock Analysis
IRONWOOD PHARMA (IRWD): Free Stock Analysis
SYNERGY PHARMAC (SGYP): Free Stock Analysis
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