To get a stroke drug to market, even the patience of a saint will do you no good. The Aug. 9, 2007 issue of the New England Journal of Medicine includes a paper that details last October's failure of Renovis Inc.'s NXY-059 in the phase III SAINT II trial. (See BioWorld Today, Oct. 27, 2006.)

NXY-059 joined a large trash heap of failed stroke drugs that already included dozens of compounds in the past decade alone, and has since been enlarged by the addition of Paion AG's and Forest Laboratories' Desmoteplase, which failed its Phase III trial for acute ischemic stroke in June. (See BioWorld Today, June 4, 2007, and related story in this issue.)

But Sven Jacobson, interim president of Remedy Pharmaceuticals, nevertheless does not think his company will end up another martyr in the attempt to get a stroke drug to market.

Remedy, founded in July 2005 with its headquarters in New York, is based on work licensed from the University of Maryland in Baltimore. To date, the company has seed funding from New York Venture Fund Carrot Capital, where Jacobson is a principal. It has no full-time employees, but is "managed virtually" by Jacobson with the help of a number of consultants.

Remedy focuses on drugs targeting a novel ATP gated channel, which senses and responds to cellular energy levels. Ischemic stroke is the first indication the company has in its sights, but Jacobson told BioWorld Today that the channel "is novel enough and exciting enough to keep us busy for a long time. Clearly there are opportunities in spinal cord injury, traumatic brain injury, and hemorrhagic stroke," he added. "And we hold the license to all those fields of use."

The reason Jacobson is optimistic about Remedy's ability to beat the odds is that the company is working on an FDA-approved drug: the diabetes drug glyburide. And the company has human data, albeit retrospective and in patients that were not randomized to the treatment, that suggested the drug works in humans to ameliorate the consequences of stroke.

"To my knowledge, no one prior to us has been in a position, before going into the clinic, of having at least some indication that their drug works in humans," he said.

The indication he refers to is published in the September 2007 issue of Stroke, where researchers - including J. Marc Simard from the University of Maryland at Baltimore, upon whose research Remedy's approach is founded - reviewed medical records of patients with diabetes who were hospitalized after suffering an acute ischemic stroke.

The scientists found that diabetic patients who were on glyburide or two related drugs had significantly better outcomes than matched diabetic controls. The improvements did not correlate with blood sugar levels, suggesting that the drugs did not merely improve stroke outcomes because patients who were taking them had better blood sugar control.

The paper was accompanied by an editorial urging a prospective randomized trial of glyburide and its relatives for ischemic stroke. Such a trial is indeed Remedy's plan; the company is about to begin pre-investigational new drug discussions with the FDA and hopes to be in Phase II trials by the end of 2008.

Along with the need for a prospective randomized study, the big question is whether the drug will be successful if it is administered after a stroke, rather than before. No human data exist on that question, but from animal data, Jacobson is optimistic.

"We have animal data which show that you can delay treatment," he said. He did not want to talk about the data in detail prior to peer-reviewed publication, but said that the time window for effective treatment is "certainly comparable to what other people have thought is reasonable - about six hours."

Genentech's Activase, the only currently approved drug treatment for ischemic stroke, needs to be administered within three hours, which is one of the reasons most ischemic stroke victims never receive the drug.

Jacobson thinks that the start of the Phase II trial is a likely time for the company to switch from its current consultant-based mode to a company with actual employees. He was less sure about when the company would see the need for a Series A financing, saying only that "we want to take it far enough that it's compelling for other investors.

"I mean, I already think it's compelling," he added. "But there are a few more parts of the puzzle we are working on which will tip other investors over the edge."