IND Submission by Synergy Pharma

Synergy Pharmaceuticals Inc. ( SGYP - Snapshot Report ) 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 this year.

We note currently approved drugs for the treatment of GI inflammatory disease include Pfizer Inc.’s ( PFE - Analyst Report ) Dipentum, AstraZeneca’s ( AZN - Analyst Report ) Entocort and Salix Pharmaceuticals, Ltd.’s ( SLXP - Analyst Report ) Colazal.

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 ( BMY - Analyst Report ) , developed to treat shingles, a severe painful skin rash caused by the varicella zoster virus (the same virus that causes chickenpox).

Our Recommendation

We currently have a Neutral recommendation on Synergy Pharma. However, the stock carries a Zacks #4 Rank (Sell rating) in the short run.