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GEN News Highlights : Nov 15, 2011

Synergy Pharmaceuticals Obtains $5.64M Financing

Firm recently moved its only clinical candidate into Phase II/III for constipation.

Synergy Pharmaceuticals completed a financing in which it raised gross proceeds of approximately $5.648 million. The proceeds will be used for working capital, to advance clinical development of lead candidate plecanatide, and to bring SP-333 into the clinic.

The financing took place through the sale of 2,657,882 units, each unit consisting of one share of common stock and one common stock purchase warrant. The warrants have a purchase price of $2.125 per unit. They are immediately exercisable at an exercise price of $2.75 per share and are exercisable for five years.

On October 24, Synergy reported that it had initiated dosing of patients in a Phase II/III trial of plecanatide to treat chronic idiopathic constipation (CIC). The drug has also completed a Phase I study in patients with irritable bowel syndrome with constipation.

Plecanatide is a member of a new class of essentially nonsystemic drugs called guanylate cyclase C (GC-C). It is a synthetic analog of uroguanylin, a natriuretic hormone that regulates ion and fluid transport in the GI tract. Orally administered plecanatide binds to and activates GC-C receptors expressed on epithelial cells lining the GI mucosa. This activates the cystic fibrosis transmembrane conductance regulator (CFTR) and leads to augmented flow of chloride and water into the lumen of the gut.

Activation of the GC-C receptor pathway is believed to facilitate bowel movement as well as produce other beneficial physiological responses including improvement in abdominal pain and inflammation. In animal models, oral administration of plecanatide promotes intestinal secretion and also ameliorates GI inflammation.

SP-333 is a second-generation GC-C agonist with the potential to treat gastrointestinal diseases such as ulcerative colitis. Synergy plans to file an IND application in the first half of 2012. SP-333 will be the second drug from Synergy’s portfolio of GC-C agonists to enter the clinic.

"SP-333, to our knowledge, represents the most stable GC-C agonist ever developed," states Gary S. Jacob, Ph.D., president and CEO of Synergy Pharmaceuticals. “The stability of SP-333 to proteolytic degradation in simulated intestinal fluid suggests it to be an ideal GC-C agonist for exploring this class of drugs to treat inflammatory bowel diseases such as ulcerative colitis.”

SP-333 also is a synthetic analog of uroguanylin. Deficiency of this hormone is predicted to be one of the primary reasons for the formation of polyps that can lead to colon cancer as well as debilitating and difficult-to-treat GI inflammatory disorders such as ulcerative colitis and Crohn disease.

Orally administered SP-333 binds to and activates GC-C expressed on epithelial cells lining the GI mucosa, producing anti-inflammatory activity. In animal models, oral administration of SP-333 ameliorates GI inflammation by suppressing production of certain pro-inflammatory cytokines.