By Frances Bishopp
GelTex Pharmaceuticals Inc. reported preliminary results from two Phase II clinical studies of CholestaGel, a non-absorbed cholesterol reducer, showing comparable cholesterol lowering activity between once-daily and split dosing and better toleration than had been observed in a previous Phase II study reported last year.
CholestaGel is a non-absorbed hydrogel that binds and removes bile acids from the intestinal tract. This activity stimulates the liver to remove cholesterol from the bloodstream to reduce bile acid levels.
The new studies were designed to evaluate dose response and dose frequency. The first, a Phase IIc study, which compared once-daily dosing against split dosing in 120 patients, produced clear evidence that once-daily dosing is at least as effective as split dosing, Amy Wilson, director of business development at GelTex, told BioWorld Today.
Preliminary results of the IIb study, a 147-patient, multicenter dose-ranging double-blind placebo-controlled study, demonstrated comparable efficacy.
CholestaGel was well tolerated in both of the newly reported studies, with a lack of gastrointestinal side effects such as constipation, which are significant problems with existing bile acid sequestrants, she said.
CholestaGel material, Wilson said, used in these two studies, was manufactured by an improved process in order to increase the stability of the process and to make it more cost effective. The new material, she said, did produce an increase in shelf-life and a lower cost of goods.
GelTex, of Waltham, Mass., has also developed a 650 mg tablet formulation of CholestaGel, which will be used in subsequent clinical studies of the drug, replacing the 400 mg capsule previously used. The 650 mg formulation is designed to allow a reduction in the number of tablets needed to achieve the desired reduction in cholesterol levels. The 400 mg tablet was used in both the Phase 11 studies, Wilson said and the company plans to use the 650 mg tablet formulation in another dose-ranging Phase II study, looking again at once-a-day vs twice-a-day dosing.
"This will give us an opportunity to try out what we think the Phase III studies will look like," Wilson said. "Phase III should begin in early 1998, after completion of the Phase II studies, which we hope will be by the end of the year."
In June 1996, GelTex terminated an agreement with Ono Pharmaceuticals Co. Ltd., of Osaka, Japan., to develop CholestaGel for sale in Japan, China, Korea and Taiwan. GelTex re-acquired all rights to the product in these countries.
GelTex stock (NASDAQ:GELX) closed down $0.125 Wednesday to $25.625. *