By Mary Welch

Staff Writer

Genelabs Technologies Inc. said the FDA agreed that its proposed new drug application for GL701 for systemic lupus erythematosus (SLE) was adequate for submission. The Redwood City, Calif., company also released results of its second Phase III study that showed the drug was statistically significant over the placebo in some analyses in patients with active disease.

"In September we reported that we had the results of a second Phase III trial but did not release the data," said Debra Catz Bannister, Genelabs' vice president of corporate communications and investor relations. "People have been sitting on the edge of their seats waiting for the data because back in September, we didn't even say if it was statistically significant, which it is - highly statistically significant. So we had a pre-NDA meeting with the FDA, showed them the data, and they agreed that it was adequate for submission."

Genelabs will start the process of a rolling application very early in 2000, with the completion scheduled for the second half of next year, she said.

The second Phase III trial was designed to determine whether GL701 can improve or stabilize clinical outcome and disease symptoms in people with SLE. Among the efficacy measurements were the Systemic Lupus Erythematosus Disease Activity Index, the Systemic Lupus Activity measure, the Krupp Fatigue Severity Score and a patient global assessment.

In the double-blind, placebo-controlled trial, 381 women were randomized to receive either an oral dose of 200 mg of GL701 or placebo once a day for 12 months. In one analysis, the proportion of patients with active disease who responded to treatment with GL701 was 66 percent to 49 percent for placebo patients (p=0.005).

In addition, the advantage of GL701 over placebo was consistent among secondary efficacy variables as well, the company said.

However, Genelabs refused to discuss other details of the trial, including whether or not some subsets did not achieve statistical significance.

"Just because we said that GL701 demonstrated statistical significance in some analyses should not lead to the inference that it did not in others," Bannister said. "We don't want to talk about other parts of the trial until we can present them at a scientific study and get them published. We don't want to jeopardize the integrity of the data."

GL701 contains prasterone, the generic designation for dehydroepiandrosterone (DHEA), as its active ingredient. DHEA is a naturally occurring hormone produced by the adrenal glands. SLE patients typically have abnormally low levels of DHEA.

SLE affects about 1 million people worldwide, primarily women. If approved GL701 would be the first new treatment for SLE in 40 years.

Genelabs Technologies' stock (NASDAQ: GNLB) closed Monday at $4.187, up 6.25 cents.