Taris Biomedical, MIT Spinoff With Bladder Drug Device, Leaps Ahead To Mid-Stage Trial

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at a Kendall Square coffee shop, is a thin flexible tube with a wire inside made of nitinol to give it strength and flexibility. The wire can be pressed down until it’s narrow enough to slide through a catheter into the bladder. But once inside, it springs out into a wider pretzel-like shape, is released, and stays there after the catheter is removed.

The shape is important because it allows the Taris device to stay inside the bladder despite all the pressure it faces from urine that could force it back out, Bunt says. The coating is made to be soft enough so it won’t irritate the bladder’s inner lining. And, importantly, the coating has one tiny hole that allows the device to release a dose of lidocaine anesthetic over a two-week period, she says. Then a medical professional can remove it.

How well does this thing really work? Bunt won’t say, but the trial did randomly assign patients to get the Taris technology or a control procedure. The results were good enough that they prompted Taris to get ready for Phase II, by hiring a new chief medical officer, Julie Lekstrom Himes, who previously worked at Coley Pharmaceuticals, Millennium Pharmaceuticals, and the NIH.

For now, Taris thinks it can continue to go it alone in developing the LiRIS. The company has 10 employees, and 10 consultants helping it prepare for the next step. Taris is looking for partners to help it develop the technology for other uses beyond interstitial cystitis, and it has been approached by more than one company, Bunt says. Taris is surveying other medical conditions for which localized drug delivery to the bladder might be useful, including bladder cancer, overactive bladder, and urinary tract infections. All told, these and other bladder conditions are thought to affect an estimated 50 million people in the U.S., Taris says.

One competitor on the horizon is the world’s biggest drug company, Pfizer (NYSE: PFE). The New York-based company is developing an antibody drug called tanezumab that’s nearing a mid-stage trial of 360 patients with interstitial cystitis, scheduled to start in January.

“We see [the Pfizer drug] as a complementary therapy to our LiRIS system,” Bunt says, because the Taris system acts locally in the bladder, while the Pfizer drug works differently by circulating through the bloodstream. Pfizer, which knows urologists quite well because of its experience with sildenafil (Viagra), may also help drum up demand for better bladder treatments which could someday benefit Taris, Bunt says.

So the stakes are getting high for Taris, and it’s all happening quite fast for a company that didn’t move into permanent offices and labs until January. When the data on the first trial comes out in a scientific journal, Taris will be “ready to go out with a bang,” Bunt says. But so far, she says, “it’s been a great ride, a very fast one.”

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