Emerging Drug Developer: CoLucid

CoLucid helps define lean and mean in biotech

A roster of new biotech companies has sprung up recently that relies on a virtual business model to keep costs down as they advance therapies to proof of concept. But CoLucid Pharmaceuticals may well set the pace for what qualifies as lean-and-mean these days.

There are only four full-time employees at the company, says CEO James White, PhD. Even if you combined all the part-timers, the payroll would still add up to only 10 full-time staffers. And rather than rent a headquarters space and bring in talent from around the country, Durham, NC-based CoLucid's approach has been to let its people stay put, using all the communications technology at their disposal to keep people connected, coordinated and focused on their projects.

Think low overhead.

"Most of the money," says White, who calls Boston home, "is going to the science."

CoLucid got its start when Eli Lilly put a portfolio of development programs up for licensing in 2005. One of those became COL-144, a migraine therapy which became the lead development program of the fledgling biotech.

"It all has to do with the formulation," explains White. "When Lilly began the program they studied it intravenously in Phase I. That's what we inherited." The advisory board felt that the company's best start was to continue the IV program, study side effects and efficacy in a European study and then switch to an oral formulation. COL-144 selectively targets 5HT1F receptors expressed in the trigeminal nerve pathway.

"We saw very good results from that study," says White, "and that encouraged us to complete development. We have just completed a Phase I in oral formulations with very good safety and the same blood levels at oral as in IV."

The key is to achieve a better therapeutic effect than triptans - which have a similar mechanism of action -- without producing the same cardiovascular side effects. "This approach should allow us to relieve migraine pain without having coronary arteries narrowed," says White.

The plan now is to get through Phase II later this year with a tablet that can replicate the same positive data seen in the IV study. That study should get underway by the end of this year or early next and will take four to six months to complete. 

There's also a preclinical candidate for the promotion of wakefulness - a stimulant the company believes can work without any addictive side effects - that's scheduled to start Phase I early next year. That candidate is the product of a chemistry platform that CoLucid licensed that holds the promise of producing new drug candidates - delivering therapies to the brain with multiple therapeutic effects on the central nervous system -- as the company takes root and expands.

CoLucid was founded by Pappas Ventures, which joined a $25 million Series B round at the beginning of July that included Domain Associates, Pearl Street Venture Funds and Triathlon Medical Ventures and was led by Care Capital. 

That money takes the company to the doorstep of a Phase III trial on its lead program and through Phase I for its two follow-up programs. From there, CoLucid has the potential to forge a partnership deal for COL-144. 

"We certainly are interested in talking to several people about the potential to partner," says White. After that, if the IPO market still looks tight, there's also the potential to go to a Series C round and continue to advance the science themselves. 

But don't look for any sudden influx of new recruits. The virtual model has a ways to run at CoLucid.

"It works very well from preclinical through Phase II," says White about the business model. "That's the sweet spot where this can work most efficiently. You can cut to the chase, find the best people happy living where they are, working on an exciting program."

It doesn't really matter these days that the CEO is in Boston, a handful of top executives are scattered around the country, a trial takes place in Europe or the SAB is scattered around the world, says White. 

The virtual model "has allowed us to rapidly get the best possible team together."

Now it all comes down to the data they produce.