Genelabs Submits Phase III Lupus Study Protocol to FDA

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Genelabs Submits Phase III Lupus Study Protocol to FDA

WASHINGTON (Reuters Health) Nov 15 - Genelabs Technologies Inc. said on

Friday that it has submitted a protocol to the US Food and Drug

Administration (FDA) for a phase III study requested by the agency as a

condition for approval of the lupus drug Prestara (prasterone).

If approved, Prestara could become the first new lupus drug to hit the US

market in about 40 years.

The FDA requested the additional study when it deemed the drug approvable

this summer. The trial is designed to confirm an increase in bone mineral

density observed in a phase III study of women with mild to moderate

systemic lupus erythematosus who were taking low-dose glucocorticoids.

The company said the protocol it submitted calls for a multicenter,

randomized, placebo-controlled, double-blinded study to be conducted at

leading US medical centers with a primary endpoint of bone mineral density

at the lumbar spine.

The protocol calls for the enrollment of about 110 women with systemic lupus

erythematosus who are receiving glucocorticoids. They will be treated for

six months with 200 mg per day of Prestara or placebo.

The firm hopes to begin the trial before the end of this year.

Formerly known as Aslera, Prestara is Genelabs' lead product candidate.

Prestara has US fast-track status, which allowed Genelabs to submit clinical

data on a rolling basis.