Synergy Pharmaceuticals Inc.
) recently announced the submission of an Investigational New Drug
(IND) application to the US Food and Drug Administration (FDA) for
its inflammatory bowel disease (IBD) candidate, SP-333.
SP-333, a second generation guanylyl cyclase C (GC-C) receptor
agonist, has the potential to be developed for the treatment of
gastrointestinal (GI) inflammatory disorders and diseases.
Synergy Pharma is looking to initiate a phase I study with the
candidate later this year. The study is expected to enroll more
than 300 patients at 40 sites in the US.
In pre-clinical studies, 0.05 mg/kg body weight dosage of SP-333
demonstrated superior anti-inflammatory activity when compared to
100mg/kg dosages of 5-aminosalicylic acid (5-ASA).
Synergy Pharma primarily develops drugs for the treatment of GI
disorders and diseases. The company's lead candidate, plecanatide,
is being developed for GI disorders.
The company is developing plecanatide for the treatment of
constipation-predominant irritable bowel syndrome (IBS-C). The
company plans to initiate the first trial in IBS-C patients later
We note currently approved drugs for the treatment of GI
inflammatory disease include
) Entocort and
Salix Pharmaceuticals, Ltd.
Synergy Pharma was in the news recently due to the acquisition
of all assets related to FV-100, an oral nucleoside analogue, from
Bristol-Myers Squibb Company
), developed to treat shingles, a severe painful skin rash caused
by the varicella zoster virus (the same virus that causes
We currently have a Neutral recommendation on Synergy Pharma.
However, the stock carries a Zacks #4 Rank (Sell rating) in the
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