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

Taris Biomedical played its cards close to the vest in its early days, but it was apparently moving with great speed. The Cambridge, MA-based biotech company, a startup from the MIT labs of Michael Cima and Bob Langer, left stealth mode about six months ago and is already bounding ahead to mid-stage clinical trials.

Taris raised its first $15 million in August 2008, a story which my colleague Ryan McBride broke for us back in June. A couple weeks later, Christine Bunt, the company’s co-founder and chief operating officer, revealed at our XSITE event that the company was already designing its first clinical trials, including one for interstitial cystitis, sometimes called painful bladder syndrome. By the time I met Bunt for a follow-up interview in early November, she surprised me by saying the company had passed its first safety trial and was prepping for a Phase II study that could offer real evidence that its idea works in people.

Today, the company is formally announcing that it passed the first trial, without providing details, other than to say results will come out soon in a peer-reviewed scientific journal. But other companies that have tried similar drug-device combo treatments for the bladder have failed in their first clinical trial, which is what makes this trial noteworthy. Langer said in a statement that the initial Taris trial matters because it “validates the core platform technology.”

So what has enabled Taris to move so quickly?

“The FDA and the NIH recognize the unmet need for interstitial cystitis,” Bunt says.

What it means is there aren’t many other good treatment options for the condition Taris is targeting. An estimated 1.3 million people in the U.S.—more than 90 percent of them women—suffer from varying degrees of interstitial cystitis. Scientists don’t really know what causes the condition, and it’s hard to diagnose. But urologists and primary care doctors are all too familiar with the complaints people make about frequent urination, and pain during urination, which can be intense. In some severe cases, patients have to urinate as many as 60 times a day, according to the National Institutes of Health.

Christine Bunt

Christine Bunt

Painful and frequent urination may not sound all that serious at first, but Bunt goes out of her way to emphasize that the medical community is putting a high priority on new therapies. The suicide rate in patients with this condition is five to seven times higher than the national average, Bunt says. The NIH supports a group of researchers in the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network, who are seeking to better characterize the disease, with a budget that exceeds $26 million, Bunt says.

Johnson & Johnson’s pentosan (Elmiron), an oral tablet, is one treatment option. It was cleared for sale by the FDA in 1996, but it only helps relieve symptoms for about 30 percent of patients, according to the NIH. Scientists aren’t sure how it works, although one hypothesis is that it may repair defects in the bladder lining.

Another option is basically a bladder wash, in which doctors insert a catheter up the urinary tract into the bladder, and release dimethyl sulfoxide, known as DMSO. Treatments are given every week or two for as much as two months, and repeated as needed, which isn’t ideal for a chronic disease, Bunt says. Instead of DMSO, some patients get a lidocaine cocktail, although that regimen isn’t FDA approved. Other patients simply take over-the-counter pain medications.

The Taris system, which it calls LiRIS, still requires a medical professional to perform the catheter procedure through the urinary tract, but it shouldn’t have to be done as often, Bunt says. The device, which Bunt pulled out of a business-card holder to show me 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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