Synthetic Biologics, Fuelled by Billionaire, Takes Aim at C.Diff

[Corrected 5/3/13, 2:30 p.m. See below.] Founded in 2001, Synthetic Biologics is a biotech company headquartered in Rockville, MD, with an office in Ann Arbor, MI, focused on the treatment of serious infectious diseases. CEO Jeff Riley says the company has been transformed during the past year or so—when billionaire biotech investor RJ Kirk came on board with a 22 percent ownership stake in Synthetic Biologics—and is now in the middle of two mid-stage clinical trials. It hopes to report results from those trials in about a year.

“Our primary focus is the anti-infective space,” Riley explains. “We looked at the different diseases out there and settled on the greatest unmet need.”

Synthetic Biologics is developing SYN-004, an oral beta-lactamase enzyme tablet to treat C. difficile overgrowth infections that patients typically pick up in hospitals. Riley says the problem is that today’s antibiotics kill all bugs, the good and the bad, and once intravenous antibiotics are in the small intestine on their way to being excreted, they wreak havoc on the good bugs critical to keeping gastrointestinal microflora in balance. Infections around intravenous catheters also keep patients in the hospital longer, which results in higher costs. [An earlier version of his paragraph incorrectly described SYN-004. We regret the error.]

Riley says that Synthetic Biologics expects SYN-004,which is currently in Phase 2b trials, to be a multi-billion-dollar drug that will especially appeal to hospital administrators once Affordable Care Act spending limits are in place and hospitals get penalized for post-surgical infections that lead to re-admissions. Because SYN-004 has no systemic exposure—it goes right to the gut instead of the bloodstream—Riley calls it “a benign way to treat a nasty problem.”

Synthetic Biologics also has a drug to treat multiple sclerosis (MS) in mid-stage clinical trials. Riley says about 40 years ago, doctors noticed that pregnant women with MS would see their symptoms disappear during the third trimester. Eventually, doctors figured out that the hormone estriol was responsible. Synthetic Biologics has developed a synthetic form of estriol called Trimesta. The company is testing Trimesta for the treatment of relapsing-remitting MS, as well as cognitive dysfunction in female MS patients.

Riley says because it’s a hormone, Trimesta is safe to take in conjunction with other MS treatment drugs. The mid-stage trials of Trimesta are being conducted in cooperation with UCLA, which Riley says is funding the study.

Synthetic Biologics has about 20 employees between its two locations, and Riley says the company is looking for novel treatments that are particularly beneficial to our healthcare system because they tackle problems that are especially costly or persistent. “We’re looking for novel ways to go after infections by creating brand new, highly targeted drugs,” he adds.

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2 responses to “Synthetic Biologics, Fuelled by Billionaire, Takes Aim at C.Diff”

  1. Incandenza says:

    What in the world? How did you confuse a beta-lactamase enzyme with an orally-administered extract from fecal material (as was in the original version of the article)?

  2. Sarah Schmid StevensonSarah Schmid says:

    You might want to ask their press person that question, as the information was in the materials that were sent over from the company’s public relations firm.