Emerging Drug Developer: Taris Biomedical

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Tiny Taris sets sights on a big target

For a tiny biotech, Taris Biomedical has some big plans. In short order the company has constructed a development platform for a drug/device combo that can apply to some of the world's biggest markets.

"It's a wonderful platform," says Christine Bunt, a CombinatoRx veteran who took the chief operating officer's job at the start-up.

The Lexington, MA-based biotech believes it can take technology developed in the labs of MIT's Michael Cima and Robert Langer--who's provided the scientific foundation for a long line-up of biotech companies--and cut a direct clinical path pointed to regulatory approval for a program designed to provide sustained release of a slightly modified version of lidocaine to the bladder. And Taris' program can be adapted to a range of conditions: interstitial cystitis/painful bladder syndrome, bladder cancer, overactive bladder, urinary tract infections and chronic pelvic pain syndrome.

"Think about drug-eluding stents designed for the cardiovascular area," says Bunt. "We're doing kind of the same thing. The device itself has about the size and weight of a medium-sized paper clip. The device looks like a small pretzel. It's very light and has a very attractive buoyancy so it can float in the urine.

"The entire length of the silicon tubing can be filled with solid drugs," she adds. "It works through very simple osmotic pressure. We can easily control the release rate" over days or weeks. "That's controlled by the surface area, the thickness and diameter of the tubing."

The simplicity of the device combined with the use of a well-defined therapeutic helped attract a group of venture backers who like to get involved at an early stage with emerging biotech companies. Flagship Ventures, Flybridge Capital Partners and Polaris Venture Partners co-led last week's $15 million Series A round.

The program originated in the lab of MIT's Cima. And very early on researchers had some tough challenges to face-- not the least of which involved the retention of the device in the bladder. Researchers are now finishing a reformulation of lidocaine "to produce tablets that are small enough to fit into silicon tubing."

The biotech operated in stealth mode for several months, in part because Bunt and others wanted a chance to sit down with the FDA to get a better sense of what regulators would be looking for from the new drug/device program. Bunt came away confident that the high unmet medical need they were tackling--where existing therapies either have limiting side effects or limited results--"creates a situation where the agency is willing to work more with the company."

It hasn't hurt that researchers are starting out with lidocaine, which has a thoroughly studied safety and efficacy profile. And the program has the added advantage of delivering a lower sustained dose of the medication.

"I can't comment on the development path," adds Bunt, when asked about the prospective development timeline. "What I can say is that we know exactly what we need to do to finalize the preclinical phase" and go on into the clinic. And this program is unlikely to take anywhere near as long as the seven or eight-year quest that many developers face this early on.

Taris currently has a staff of 13. And right now no one is planning any quick exit strategies.

Says Bunt: "I don't believe in that. I believe in building value for unmet medical needs."

What she is planning on is rapid growth,

"We are moving very fast," she says. "We'll be in Phase I in the fall followed by a Phase II study in 2010 in the first half. And you know how it is when you advance an organization into the clinical stage. We are looking at adding 8 to 10 people next year."