By Randall Osborne
SAN FRANCISCO - GelTex Pharmaceuticals Inc. said results are positive from the first Phase III trial of its product for lowering LDL cholesterol levels, and results of a second Phase III trial are expected by April, with a new drug application filing due as early as mid-year.
The favorable Phase III findings fall in line with data from Phase II trials, said Mark Skaletsky, president and CEO of Waltham, Mass.-based GelTex, who gave a presentation Monday at the 17th annual Hambrecht & Quist Healthcare Conference here.
"There shouldn't be any surprises, if Phase II is done well," Skaletsky told BioWorld Today. "It's a numbers game."
GelTex's first study of Cholestagel, evaluating 466 patients over six months, showed reductions of LDL cholesterol at all dosing levels, including a 16 percent drop at the 3.8-grams-per-day dose, and a 20 percent reduction at 4.5 grams per day. Patients took the drug in the morning and evening. Side effects were minimal.
The second study is evaluating Cholestagel for lowering LDL cholesterol at once-daily and split-dosing regimens over a six-week period. "You can take [Cholestagel] with a large meal, and for most people that's dinner, or you can split it between two meals," Skaletsky said. "We completed basically the same study - a Phase II study - in the first quarter of 1997," but the FDA asked for a repeat, he said.
Cholestagel is a non-absorbed hydrogel that binds and removes bile acids from the intestinal tract, thus stimulating the liver to remove cholesterol from the bloodstream.
Last November, the FDA approved Renagel (sevelamer hydrochloride), a non-absorbed, polymer-based phosphate binder for patients with end-stage renal disease, an event that triggered a $15 million payment to GelTex by development partner Genzyme Corp., of Cambridge, Mass. (See BioWorld Today, Nov. 3, 1998, p. 1.)
Skaletsky said Renagel marketing is going well.
"We're pleased with what we're seeing," he said. "At the end of 1998, we had over 1,200 people on Renagel." The drug is under regulatory review in Europe and Canada.
GelTex's stock (NASDAQ:GELX) closed Monday at $24.937, up $1.625.
In other news from the H&Q conference:
o SangStat, of Menlo Park, Calif., said it intends to file for marketing approval of Sang-2000, a capsule dosage of its cyclosporine formulation, based on positive results of a bioequivalence trial comparing the product to Novartis AG's Neoral capsules. SangStat's oral solution cyclosporine product, SangCya, was approved in November. SangStat intends to file for U.S. and European approvals of Sang-2000 in the first half of this year. n