La Jolla Pharmaceutical Co. said data from a Phase II trial of itslupus drug were positive, clearing the way for continued developmentof the compound, LJP 394, which is designed to shut downproduction of antibodies linked to the autoimmune disease.
Peter Ulrich, La Jolla's senior vice president of development andmarketing, said the San Diego company expects to conduct a PhaseIIb study this year to define the best treatment regimen for the drugbefore proceeding to a Phase III trial in early 1997.
LJP 394 was created with La Jolla's Tolerance Technology, whichmakes molecules that bind to the surface of B cells and that shut offtheir production of disease-causing antibodies.
LJP 394 targets double-stranded DNA antibodies, which are believedto cause kidney disease, the main killer of lupus patients.
Lupus affects more than 1 million people in the U.S., most of themwomen. In addition to kidney failure, patients can suffer skinproblems, central nervous system disorders and arthritis. Currenttreatments involve steroids and cytotoxic drugs, which attack theentire immune system and cause serious side effects.
La Jolla's Phase II trials of LJP 394 involved 58 patients with mildlupus nephritis at eight U.S. medical centers. Results of the placebo-controlled, dose-ranging studies showed the drug was well toleratedwith no significant adverse side effects and it reduced levels of thedouble-stranded DNA antibodies.
Patients were divided in nine groups and treated over four months.The average reduction in double-stranded DNA antibodies was 32percent in those receiving 10 mg weekly doses of the drug comparedwith 2 percent in patients taking a placebo. The average reduction inantibodies in patients receiving 50 mg weekly treatments was 42percent.
The Phase II data confirmed earlier studies. When LJP 394 is firstadministered it clears the double-stranded DNA antibodies floatingfree in the blood and then suppresses B cell production of theantibodies.
A Phase IIb trial, Ulrich said, will help La Jolla establish how muchdrug is needed to reach the point where antibody production becomessuppressed.
LJP 394 is not considered a cure. It is designed to stabilize the loss ofkidney function in lupus patients.
La Jolla's stock (NASDAQ:LJPC) closed Friday at $8.87, up 25cents. n
-- Charles Craig
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