CombinatoRx Judgment Day Coming Soon, Arthritis Drug Results On the Way

Xconomy Boston — 

CombinatoRx is coming to one of those defining moments where it will either vault into becoming an emerging biotech industry player or it will take a big leap backwards. The Cambridge, MA-based company (NASDAQ: CRXX) will find out within the next four weeks whether its experimental combination drug for arthritis is likely to become a multi-billion dollar product, or a big, fat zero.

If a clinical trial of Synavive succeeds, “it certainly would mean we would pop the champagne,” says Gina Nugent, the company’s vice president of investor relations. If not, “it wouldn’t really be a clean-out-your-desks moment, but it may be that you’d have to take a shot of tequila. Maybe cry a little,” she says.

CombinatoRx was founded back in March 2000, has no marketed products, and has spent $220 million through the end of June on building a pipeline of drug candidates—so this first major clinical trial counts for a lot. The company’s medicines are unusual, because instead of developing new drugs from scratch, it uses computer screening methods to find novel treatments that combine conventional pharmaceuticals in new ways to improve their effectiveness. Its lead candidate at the moment is Synavive for osteoarthritis, the painful joint disease that affects an estimated 20 million people in the U.S., according to the National Institutes of Health. This is the form of arthritis traditionally associated with old age, degeneration of the joints, and for which people still mostly take over-the-counter pain meds, or possibly Pfizer’s Celebrex.

Synavive is designed to take a common generic immune-suppressor, prednisolone, in a very low dose, and combine it with dipyridamole, an anti-blood clotting agent. The idea is that by going to a low dose of the immune suppressor, patients can avoid some of its nasty side effects, like increased risk of osteoporosis and cataracts, while the dipyridamole activates it in such a way that it retains its full anti-inflammatory pain relief action.

The drug is currently in a 279-patient clinical trial of patients with arthritic knees, called Comet-1, says John Randle, the company’s senior vice president of corporate development. The main goal is to show improved pain relief compared with a placebo after three months of treatment, with a secondary goal of showing the combination is better than just plain low-dose prednisolone by itself. Results are expected in October, Randle says.

CombinatoRx was encouraged to go this far by earlier trials. One suggested its combo could help almost two-thirds of patients achieve a 20- percent reduction in symptoms of rheumatoid arthritis after six weeks, compared with about one-third who did that well on placebo. Another study of patients with osteoarthritis in the hands found that patients on Synavive had a 31 percent average reduction in pain, compare with 7 percent on a placebo.

There was a catch here, though, with patients complaining of headaches in the earlier trials. … Next Page »

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