Emerging Drug Developer: MediQuest Therapeutics

By John Carroll

MediQuest's 13-year journey to commercialization

It's been a long, winding road for MediQuest Therapeutics, but the tiny Bothell, WA-based biotech has just taken a big step toward commercializing its first product.

Founded in 1994, MediQuest had to refocus four years ago and set out on a new development path. Yesterday, the company unveiled positive, late-stage highlights on its lead therapy. And the company hopes to use its Phase III data to round up a new venture round to fund an expansion designed to dovetail with a submission to the FDA for its first approval.

When Fred Dechow, PhD, took over as MediQuest's CEO in 2002, the company had an eight-year track record of preclinical programs that never could make the leap into human trials. The developer had racked up some solid in vitro results for its compounds to control inflammation - but a disappointing set of in vivo data. The treatments couldn't break through stubborn biological barriers.

So Dechow regrouped. MediQuest took its technology and experience and targeted topical therapies that could treat inflammatory conditions of the skin and nails: Raynaud's disease, nail psoriasis, onychomycosis and actinic keratosis. The company concentrated much of its efforts on Raynaud's disease - a stinging constriction of blood flow to hands, feet and other extremities with an estimated market potential of more than $300 million. According to MediQuest, some 2 million people - 90 percent women - seek medical treatment for Raynaud's every year. There are no other therapies approved specifically for this condition.

The Phase III trial of MQX-503 was small by most standards, involving only 109 patients. Researchers for the company said Thursday that more volunteers applying MQX-503 reported reduced severity of Raynaud's disease compared to the placebo group. The research from the late-stage study is being presented at the American College of Rheumatology meeting in Boston.

We have three programs in clinical development right now," Dechow tells FierceBiotech. "We had our clinical programs begin in 2003, when we filed our first IND." And he's banking on MediQuest's drug delivery technology to push more of these therapies through Phase III as well.

After MQX-503, MediQuest has a therapy in Phase IIb for onychomycosis, a prevalent form of toenail fungus. Another therapy for nail psoriasisis is poised to enter mid-stage trial.

Up until the summer of 2006, when venture capitalists put up the biotech's first round of $16.5 million, MediQuest relied entirely on angel investors for its survival. Much of the first round cash - which came from investors like Nova A/S, Janus and Integra Investors -- is gone now, and Dechow says he's in talks to raise more money - though he's keeping mum about when a new round could be completed. He did tell the Seattle Post-Intelligencer last summer that he expected to raise $20 million to $40 million in the next round. The money will be quickly put to use.

We are definitely going to need additional people as things develop further," says Dechow, estimating that the company's workforce of 28 could double or triple in the months after the second venture round comes together.

An NDA on MQX-503 is expected by the end of this year, says Dechow, who's hoping that the agency will accept the application and provide MediQuest with a PDUFA action date. Dechow is also working on a co-promotional deal with a bigger pharma player who could commercialize the therapy among primary care physicians who see the majority of patients. MediQuest in turn hopes to field a small sales force of its own to focus on specialists and thought leaders in the field.