RESEARCH - Prasterone for lupus: product falls at final hurdle

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Prasterone for lupus: product falls at final hurdle

Rheumawire

Oct 6, 2004

Nainggolan

Redwood City, CA - A potential new drug for systemic lupus erythematosus

(SLE), prasterone (Prestara, Genelabs Technologies Inc), appears to have

fallen flat at the last hurdle before approval.

Genelabs announced yesterday that a preliminary analysis of its phase 3

clinical trial, Study GL02-01, showed that it failed to meet its primary

end point [1]. The study was designed to measure the effect of

prasterone on the bone-mineral density (BMD) of women with SLE receiving

glucocorticoids.

Genelabs previously completed a 1-year phase 3 clinical trial in which a

subset of 55 patients receiving prasterone had increased BMD, compared

with a decrease in bone density for those on placebo. As reported by

rheumawire, this study was published in Arthritis & Rheumatism last

month, although the BMD data on the subgroup were not part of that

paper.

With Study GL02-01, the company was trying to duplicate these earlier

BMD resultsit was hoping that the new trial would confirm a protective

effect of prasterone on BMD, which would have paved the way for US

approval of the product. Genelabs shares fell by 66% after it announced

the disappointing results.

The company said it plans to continue its analysis of data from Study

GL02-01 and will seek meetings with the FDA to determine the company's

next steps.

" Although these preliminary results show that this study failed to reach

statistical significance, we are continuing to analyze the data to gain

further understanding of the results, " said AD (president

and chief executive officer, Genelabs). " This process typically takes

some time, and I regret that we will likely not have further information

to provide on Prestara until we have completed these steps. "

The failure of prasterone in this new trial will be a blow both to lupus

patients and rheumatologists treating them, who were looking forward to

a new weapon in their armamentarium. There has been no new drug approved

for lupus in almost 40 years.

Another new agent for lupus renal disease, abetimus (LPJ 394, Riquent,

La Jolla Pharmaceutical), also failed to meet its primary end point of

reducing the time to renal flare in its pivotal phase 3 trial.

Nevertheless, the company filed for US approval of the product earlier

this year and is expecting a decision from the FDA in mid-October, it

told investors recently.

" Even though our new drug application for Riquent has been accepted by

the FDA for review, and even though we have agreed with the FDA

regarding the design of a potential phase 4 trial and we have initiated

the trial, there is no guarantee that the FDA will approve Riquent in a

timely manner, or at all, " B Engle (chair and CEO, La Jolla

Pharmaceutical) told the UBS Global Life Sciences Conference last week

[2].

Both Genelabs Technologies and La Jolla Pharmaceutical are small

biotechnology companies whose lead products are prasterone and abetimus,

respectively.

Sources

Genelabs announces preliminary results of Clinical

Trial GL02-01 in women with systemic lupus erythematosus. October 5,

2004; Available at: http://www.genelabs.com/news/index.html

La Jolla Pharmaceutical to present at UBS Global Life

Sciences Conference. September 22, 2004; Available at:

http://www.ljpc.com/pressrelease/0922_04.html

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org