NEW YORK, Feb. 11 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals announced today that the last subject randomized into the SUN-Micro Phase 3 clinical trial has completed their scheduled 8 month visit. This milestone officially marks the completion of this pivotal clinical trial of its investigational drug Sulonex(TM) (sulodexide oral gelcap) in the treatment of subjects with type 2 diabetes and persistent microalbuminuria despite treatment with the maximum approved or tolerated dose of either an Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB). This randomized, double-blind, placebo-controlled study enrolled 1,056 subjects at over 150 sites worldwide.
The Company anticipates being able to report top-line results from this study before the end of March 2008, and expects that the Collaborative Study Group will make a comprehensive scientific presentation of the data at a medical conference in the 2nd or 3rd quarter. The Company is targeting an NDA filing before year end.
“The completion of the Sulonex Phase 3 clinical program is an important and significant milestone for Keryx,” stated Michael S. Weiss, Chairman and CEO of the Company, who continued, “We recognize and are grateful for the dedication, diligence and compliance exhibited by the Collaborative Study Group and the more than 1,000 patients who participated in what is considered to be the largest ever randomized study for type 2 diabetic patients with persistent microalbuminuria.”
Commenting on the news, Edmund J. Lewis, MD, co-Principal Investigator of the Phase 3 Study remarked, “We would like to commend both our Investigators and their patients for their level of commitment towards the completion of this pivotal 8-month study, marking the culmination of critical research in a disease area for which there has not been a novel treatment option in almost 15 years. We look forward to assembling and analyzing the data from this study.”
ABOUT THE SULONEX (sulodexide oral gelcap) PHASE 3 and PHASE 4 CLINICAL PROGRAM
Sulodexide is in a pivotal Phase 3 and Phase 4 clinical program under a Special Protocol Assessment with the Food and Drug Administration. These trials are being conducted by the Collaborative Study Group, the world’s largest standing renal clinical trials group.
The clinical plan to support an NDA approval for sulodexide under Subpart H (accelerated approval), as agreed upon with the FDA under an SPA, consists of: (i) a single Phase 3 trial in subjects with microalbuminuria based on the surrogate marker of regression of microalbuminuria as the primary endpoint; (ii) supportive data from previously conducted clinical studies; and (iii) substantial recruitment into our Phase 4 confirmatory study that will measure clinical outcomes in subjects with overt nephropathy, or macroalbuminuria.
The Phase 3 clinical program is a multi-center, randomized, double-blind, placebo-controlled study, comparing 200 mg daily of sulodexide versus placebo, with a 1:1 randomization between the two arms. The objective of this study is to evaluate the safety and efficacy of sulodexide in subjects with type 2 diabetes and persistent microalbuminuria, or diabetic nephropathy, despite being treated with a maximum approved or tolerated dose of an angiotensin II receptor blocker (ARB) or angiotensin-converting enzyme inhibitor (ACEi). The study is designed for subjects to be on drug for six months, followed by two months of evaluation off-drug.
During the drug and off-drug evaluation period, all subjects in the study population are expected to continue to receive maximum approved or tolerated doses of ACEis or ARBs. Subjects who were not already on maximum approved or tolerated doses of ACEis or ARBs for 120 days were required to go into a run- in period prior to randomization of up to 120 days. This run-in period was designed to stabilize blood pressure and to confirm persistent microalbuminuria while the subjects are treated with maximum approved or tolerated doses of ACEis or ARBs.
The primary endpoint for the Phase 3 clinical trial is “therapeutic success” at 6 months, where therapeutic success is defined as (i) conversion from microalbuminuria to normoalbuminuria, as measured by albumin/creatinine ratio (ACR), with at least a 25% reduction in ACR relative to baseline ACR, or (ii) a 50% reduction in ACR relative to baseline ACR.
Concurrently with the Phase 3 clinical trial, the Company is continuing enrollment into its Phase 4 clinical trial, which is a randomized, double- blind, placebo-controlled study, also comparing 200 mg daily of sulodexide versus placebo, with a 1:1 randomization between the two arms. The objective of this Phase 4 study is to evaluate the efficacy of sulodexide in reducing the rate of progression to End-stage renal disease and adverse clinical sequelae in subjects with type 2 diabetes and macroalbuminuria or overt diabetic nephropathy, despite being treated with a maximum approved or tolerated dose of an ARB. All subjects in the Phase 4 study population are expected to continue to receive maximum approved or tolerated doses of ARBs during the course of the study. The Phase 4 study is designed to enroll approximately 2,200 subjects.
The Company has committed to the FDA, as a condition to the accelerated approval of sulodexide based on the Phase 3 clinical trial, that the Phase 4 study would be substantially enrolled at the time of the filing of the NDA for sulodexide.
ABOUT SULONEX (sulodexide oral gelcap)
Sulodexide belongs to a proposed new class of nephroprotective, or kidney protecting, drugs, known as the glycosaminoglycans. A variety of members of this chemical family have been shown to decrease pathological albumin excretion in diabetic nephropathy in humans. Some of the members of this chemical family include the following approved drugs: standard heparin, low molecular weight heparin and danaparoid. These agents all require therapy by injection and are all potent anticoagulants, which are blood thinners capable of inducing bleeding. Sulodexide, on the other hand, is given orally and, in this form, has demonstrated little, if any, anticoagulant effects to date.
Keryx owns the exclusive rights to sulodexide for the treatment of diabetic nephropathy in North America, Japan and certain other markets outside of Europe. Diabetic nephropathy is a long-term complication of diabetes in which the kidneys are progressively damaged. Sulodexide is a glycosaminoglycan compound with structural similarities to the broad family of marketed heparins and low molecular weight heparins. This drug has been marketed in a number of European, Asian and South American countries for many years by our licensor for certain cardiovascular conditions and has an established safety profile at the doses used for such indications. Additionally, it has been demonstrated in multiple clinical trials conducted in Europe and the U.S., including two randomized, double-blind, placebo-controlled Phase II studies, that sulodexide can reduce urinary protein excretion in patients with diabetic nephropathy.
ABOUT KERYX BIOPHARMACEUTICALS, INC.
Keryx Biopharmaceuticals, Inc. is focused on the acquisition, development and commercialization of medically important, novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer. In addition to sulodexide, Keryx is developing Zerenex(TM), an oral, iron- based compound that has the capacity to bind phosphate and form non-absorbable complexes. Zerenex is currently in Phase 2 clinical development for the treatment of hyperphosphatemia (elevated serum phosphorous levels) in patients with end-stage renal disease. Keryx is also developing clinical- stage oncology compounds, including KRX-0401 (perifosine), a novel, first-in- class, oral modulator of Akt, a pathway associated with tumor survival and growth, and other important signal transduction pathways. KRX-0401 is currently in Phase 2 clinical development for multiple tumor types. Keryx also has an active in-licensing and acquisition program designed to identify and acquire additional drug candidates. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release anticipating future clinical and business prospects for our lead drug candidate Sulonex, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward- looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: the results of the Phase 3 study for Sulonex could be inconclusive or negative; even if we receive positive results from the Phase 3 study for Sulonex, we may not be able to finalize the NDA before year end for various reasons including the completion of necessary non- clinical studies; the completion of manufacturing preparations; or other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information in our website is not incorporated by reference into this press release and is included as an inactive textual reference only.
CONTACT: Lauren Fischer of Keryx Biopharmaceuticals, +1-212-531-5965
Web site: http://www.keryx.com/
