By Jim Shrine
GelTex Pharmaceuticals Inc. reported results of a Phase III trial that showed its cholesterol-reducing agent, Cholestagel, was as effective in once-daily dosing as split dosing.
Those results would help in convenience of administration for patients, if the drug is approved. They also support previous Phase III and Phase II data showing Cholestagel, a non-absorbed hydrogel that binds and removes bile acids from the intestinal tract, reduced LDL cholesterol levels by 15 percent to 20 percent.
Meg Malloy, senior analyst at Hambrecht & Quist LLC, in New York, said the news means GelTex is on track to file a new drug application (NDA) by the middle of the year.
Conventional therapy for lowering cholesterol is a class of drugs called statins. Separately, GelTex, of Wal tham, Mass., is in Phase II studies testing Cholestagel in combination with statins. An earlier study showed the combination offered significant reduction of LDL cholesterol compared to a statin alone.
Malloy said Cholestagel would not replace the more-potent statins, but has a place in the market if approved. ¿The goal of Cholestagel is to provide a safe and tolerable alternative,¿ she said.
The market for Cholestagel might include the 5 percent of patients who don¿t respond to statins; those worried about long-term toxicity issues; women of childbearing age; and young people who prefer not to undergo long-term statin therapy, Malloy said.
Another opportunity is in the use of Cholestagel in tandem with statins.
Paul Mellett, chief financial officer at GelTex, said the company would like to seek ¿class¿ labeling for the product, meaning an indication for use as a monotherapy or in combination with statins.
The ongoing Phase II combination studies ¿ with Merck & Co.¿s Zocor and Warner-Lambert Co.¿s Lipitor ¿ are expected to be completed by the time the NDA is filed.
¿We never intended to compete with statins,¿ Mellett said. ¿We view it as a complementary product.¿
The new Phase III trial involved four arms: morning dosing, evening dosing, split dosing and placebo. Results from the drug arms were consistent regardless of dosing schedule. The 100-patient trial was conducted at four centers in Europe over a six-week period.
The previous Phase III study, the results of which were released in January, involved 466 patients followed for six months. Results showed a significant and dose-dependent reduction in LDL cholesterol levels.
Elevated cholesterol is a major risk factor in the development of atherosclerosis and coronary heart disease. GelTex said only 6 million of the 24 million Americans with the condition are receiving treatment.
GelTex¿s stock (NASDAQ:GELX) fell 68.7 cents per share Monday, closing at $17.875. n