Associate

Santarus Inc. hit a fairly high hurdle in its SAN-05 Phase III trial, and partially unveiled early positive results.

SAN-05, the San Diego-based company's oral, immediate-release omeprazole suspension for upper gastrointestinal bleeding in critically ill ventilated patients, performed well enough to reach the primary endpoint in the trial with a particularly stringent "p" value in a head-to-head study against intravenous cimetidine, a standard of care in the indication.

"We are still doing the analysis on the secondary endpoints, but we can say we did hit the statistical significance of the primary endpoint," said Gerald Proehl, Santarus CEO and president. The secondary measurements - pH control in patients and how many of them needed a dose increase vs. intravenous cimetidine - are "very supportive of the results in the primary endpoint" and "look favorable," he said.

The trial involved 359 patients who had an acute physiology and chronic health evaluation score of more than 11, and at least one risk factor for upper GI bleeding in addition to mechanical evaluation. Patients could not be bleeding prior to the trial.

Intravenous cimetidine is an approved histamine-2 receptor antagonist and the only marketed drug in the U.S. for the upper GI bleeding indication. The company estimates there are 4 million patients annually in the U.S. who might be at risk for upper GI bleeding.

The trial was a non-inferiority study. Privately held Santarus wanted to show "compelling data" in order to have "the potential to have [SAN-05] approved with one study." To do so, it set the "p" value at 0.025. By Santarus declaring that the primary endpoint was reached, it's assumed the "p" value came in below that 0.025 figure.

SAN-05 "is a combination of an antacid and omeprazole," Proehl told BioWorld Today. In combating upper GI bleeding, "the primary goal is to try to increase pH and hold pH up for as long as you can." SAN-05 offers the additional benefit of its route of administration - down a nasal gastric tube once daily - and might be useful outside the walls of the hospital as well.

"Quite honestly, what we have found is that once patients leave the ICU, physicians might want to continue the patients on the product," Proehl said. "It is [peach] flavored. You could take it orally if the doctor deemed it important."

The full analysis of the trial is expected to be complete by the end of November or early December, Proehl said, and the company plans to file for approval about six months from now. The drug is not partnered, but Proehl and Santarus plan to remedy that.

"We are currently talking with a number of pharma partners," he said. "We expect to sign someone within the next 12 to 18 months."

The company also is developing a chewable tablet for immediate-release omeprazole and is planning a pilot study in the fourth quarter. If all goes well there, it would look to start pivotal trials in 2004. Santarus is investigating other formulations that would broaden the use of the drug. Proehl said it could have use in general heartburn, gastric ulcers, erosive esophagitis and, potentially, pediatric gastroesophageal reflux disease, among other indications.

In May the company said it raised $51.4 million in a private placement, its third round of outside funding. With that money in its back pocket, Santarus is financially in "a very good position," said the company's vice president, chief financial officer, treasurer and secretary, Debra Crawford.

"We have more than $55 million in cash," she told BioWorld Today. "Things can change, but our current burn is about $2 million a month."