Genelabs: FDA will require additional phase 3 trial of Prestara for women with lupus

By E. Janene Geiss

Philadelphia, Jan. 13 - Genelabs Technologies, Inc. said that the Food and Drug Administration has indicated that the company will need to conduct an additional, well-controlled phase 3 clinical trial to support a New Drug Application for Prestara to treat women with systemic lupus erythematosus.

But while the company said it is currently designing the needed trial, it does not have the funding to conduct the trial on its own. Without a collaborator, Genelabs said it may need to delay or discontinue further development of Prestara, according to a company news release.

The company said it also discussed with the FDA its options for pursuing Prestara in an indication of prevention of loss of bone mineral density in women with lupus. Genelabs has pursued a bone mineral density indication since receiving an approvable letter for its Prestara New Drug Application in 2002.

The FDA said that additional positive prospective phase 3 clinical trial data also would be necessary before the FDA would consider reviewing an NDA for bone mineral density in lupus, officials said.

Based on those indications, Genelabs said it plans to pursue an indication for treating the signs and symptoms of lupus as a more viable route forward for Prestara than the bone mineral loss indication.

"I believe the FDA recognizes the need for new drugs for lupus, but at the same time they also must adhere to their established standards for approval. They are indicating that they will require one additional pivotal trial in order to approve our NDA for the treatment of lupus. I am encouraged that the agency has acknowledged the positive outcome from our previous study evaluating Prestara's overall impact on women suffering from lupus. Genelabs is potentially only one positive clinical trial from approval for a difficult and debilitating disease that has very limited and inadequate treatment options," James A.D. Smith, president and chief executive officer, said in the release.

Genelabs said it is designing an additional clinical trial for the lupus indication.

The company said it plans to work with the FDA in the development of the protocol, as suggested by the FDA in the recent meeting, and plans to formally meet with the agency again regarding the prospective clinical trial design.

Genelabs said its first double-blind, placebo-controlled clinical trial of Prestara for lupus enrolled 191 patients and evaluated Prestara's ability to reduce the glucocorticoid dose in steroid-dependent women with mild to moderate lupus while maintaining stable or improved systemic lupus erythematosus disease activity.

The primary endpoint was sustained reduction in glucocorticoid dose to levels approximately equivalent to those normally produced by the adrenal glands. Results showed that patients who received the 200 mg daily doses of Prestara had a higher response rate than patients who received placebo, particularly for those patients with active disease at baseline. The results of this study were published in the July 2002 issue of Arthritis and Rheumatism.

Genelabs also completed a second double-blind, placebo-controlled clinical trial, which enrolled 381 patients and evaluated the ability of Prestara to improve or stabilize clinical outcome and disease symptoms in women with mild to moderate lupus. The primary endpoint was stabilization or improvement in two lupus disease activity measures, two health-related quality of life measures and no clinical deterioration. There was a statistically significant greater rate of response for Prestara patients than for those on placebo.

In late 2002, the FDA advised Genelabs that it considered the study to be positive, adequate and well-controlled. The results of this clinical trial were published in the September 2004 issue of Arthritis and Rheumatism.

For the bone mineral density indication, Genelabs conducted a separate study of 55 patients to assess the effect of Prestara on the bone mineral density of women with lupus who were taking glucocorticoids.

An analysis of the patients who had pre- and post-treatment bone mineral density measurements showed that the group of patients receiving Prestara had a statistically significant increase in bone mineral density, compared to a decrease in bone density for the group of patients on placebo. The results of this study were published in the April 2005 issue of The Journal of Rheumatology.

Genelabs is a Redwood City, Calif., biopharmaceutical company focused on development of pharmaceutical products to improve human health.

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