It’s a version of naproxen, a non-steroidal anti-inflammatory drug (NSAID) widely used to treat arthritis and other conditions, that has been modified to reduce the gastrointestinal side effects of NSAIDs. Such side effects—which include bleeding and perforations of the digestive tract—are responsible for some 17,000 to 20,000 deaths in the U.S. each year, and more than a billion dollars in healthcare costs, according to Fink. The development of in the 1990s of Vioxx, Bextra, and Celebrex—so-called COX-2 inhibitors—was an attempt to produce NSAIDs with minimal gastrointestinal side effects, but Vioxx and Bextra were notoriously pulled from the market after they proved to raise the risk of heart attack and stroke.
It turns out that all NSAIDs carry some cardiovascular risks. Recent research points to naproxen as one of the safest from that perspective, but there’s still the gastrointestinal problems to contend with. That’s where Logical’s drug, LT-NS001, could come in.
Logical in-licensed LT-NS001 from a struggling California biotech when it became clear early on in the startup’s history that the two pieces of University of Pittsburgh science around which the company was founded were too far from commercialization to attract investors. (The company continues to pursue that work, however, with the aim of producing treatments for diabetes, obesity, rheumatoid arthritis, and inflammatory bowel disease.) The idea behind the drug is elegantly simple: attach an extra molecule to naproxen that renders the drug inert in the stomach and intestine, where it could otherwise cause harm, but that falls off as soon as the drug reaches the bloodstream, allowing it to get down to business blocking inflammation and relieving pain. Competing approaches—and there are many—include paring NSAIDs with drugs that protect the stomach and bypassing the stomach altogether by delivering the drug through a patch or cream.
In animal tests, Fink says, LT-NS001 has only a “trivial” level of gastrointestinal toxicity, while providing relief from pain and inflammation that’s equivalent to regular naproxen. The company just started a Phase 1b clinical trial of the drug in Holland (the drug had already undergone one Phase 1 trial when Logical licensed it). It plans to finish that trial and begin, and hopefully complete, a proof-of-principle trial in 2008, Fink says. Should the drug continue to look good in such Phase 2 trials, Logical will look for a partner to help with the larger, more expensive Phase 3 studies, he says.
Logical is also in discussions for the rights to another clinical-stage drug, according to Fink. It’s all part of the firm’s strategy of being a “semi-virtual company” that keeps fixed costs and headcount down by making strategic use of in-licensing, outsourcing, and partnerships. To manage all those moving parts, Fink and Green have assembled a small group of senior executives with a good number of years in drug development under their belts. “It’s a very experienced management team,” says Fink, “which is terrific, because I’m not experienced.”
Before the Jimi Hendrix seeps too deeply into your brain, let me take you on a little detour back to the automotive metaphor I so tortured at the beginning. Fink says he hasn’t yet sold his house in Pittsburgh—he has a small apartment here and is still doing some commuting between the two cities. And it occurs to me that, by combing the clinical-stage work in-licensed from industry with preclinical work born of academia, Logical is not only jump-starting its own progress but also providing a roadmap that could ease the commute of other young companies between the academic and corporate worlds. One more reason why I’ll be interested to see how Logical enjoys the ride.
