Following an end-of-phase 2 meeting with the FDA, Synergy Pharmaceuticals (SGYP) will begin two phase 3 studies of plecanatide, the company’s lead drug candidate, in Irritable Bowel Syndrome with Constipation (IBS-C) in the fourth quarter. The company is already running two large phase 3 studies of plecanatide in Chronic Idiopathic Constipation (CIC). SGYP is trading down on Tuesday in-part because the 2,100-patient phase 3 program will be expensive – though the magnitude of these trials should come as no surprise, investors anticipate some form of financing in the next year – but also as a result of sector-wide weakness; the iShares Nasdaq Biotechnology ETF (IBB) is down 5% in two days of trading.
Synergy ended the first quarter of 2014 with $70.6 million in cash & equivalents. Through a controlled equity sales agreement with Cantor Fitzgerald, the company can (as of May 9) raise an additional $48.6 million selling common stock into the open market.
The phase 3 IBS-C program will include two doses of plecanatide, 3mg and 6mg, consistent with dosing in the current phase 3 CIC program. The IBS-C trials will each enroll 1,050 patients and will compare the two plecanatide doses to placebo.
One or more of PropThink’s contributors are long SGYP.
