>>Metabasis Announces Completion of Enrollment in the Phase 2b Clinical Trial for CS-917 in Patients With Type 2 Diabetes
Thursday February 1, 8:30 am ET
SAN DIEGO, Feb. 1 /PRNewswire-FirstCall/ -- Metabasis Therapeutics (Nasdaq: MBRX - News) today announced that enrollment was recently completed in the ongoing Phase 2b clinical trial for CS-917, a compound being developed for the treatment of type 2 diabetes by Daiichi Sankyo pursuant to a licensing agreement between the two companies. This proof-of-concept study is designed to evaluate safety and tolerability after three months of dosing of CS-917, as well as its effect on blood levels of the molecule HbA1c, an important measure of glucose control in patients with type 2 diabetes.
A total of 392 patients have been enrolled at over 100 sites in this randomized, double-blind, placebo controlled trial. Patients are evenly distributed among four groups consisting of two active dose groups of CS-917, an active comparator and placebo. If successful, the trial could support selection of a dose for a pivotal Phase 3 clinical trial.
In two successfully completed Phase 2a clinical trials (14-day and 28-day) in patients with type 2 diabetes, CS-917 was well tolerated and significantly reduced the elevated blood glucose levels that characterize the disease. The results from the 14-day Phase 2a clinical trial involving 39 patients were presented at the 2006 American Diabetes Association meeting and showed that oral administration of CS-917 in the morning resulted in significant lowering of post-dose fasting plasma glucose (FPG) compared to placebo. This study was followed by a 28-day study in 146 type 2 diabetic patients which indicated that CS-917 was most likely to be administered twice daily.
"The completion of patient enrollment in this trial is another step forward in the development of this novel compound, designed to inhibit gluconeogenesis, for patients suffering from type 2 diabetes," stated Dr. Paul Laikind, president and chief executive officer of Metabasis. "With an estimated 180 million people worldwide with type 2 diabetes and with the incidence continuing to grow, new treatment options are urgently needed as current therapies often only achieve modest reduction in the production of glucose. We believe that CS-917 is the first of a new therapeutic class that has the potential to be an important distinctive approach for treating patients who suffer from type 2 diabetes."
Dr. Mark Erion, executive vice president of research and development and chief scientific officer at Metabasis, commented. "CS-917 acts as a direct inhibitor of the pathway in the liver responsible for the production of glucose, the gluconeogenesis pathway. CS-917 is being evaluated to determine whether it may be used alone or in combination with certain other drugs designed to enhance removal of glucose from the bloodstream, and for the large number of patients who are unable to take metformin, a treatment currently used as first line therapy in patients with type 2 diabetes."
About CS-917:
CS-917 is a compound for the treatment of type 2 diabetes that was discovered by using Metabasis' proprietary NuMimetic(TM) technology, and is being developed by Daiichi Sankyo pursuant to a licensing agreement between Metabasis and Daiichi Sankyo. Metabasis retains co-promotion rights in North America. CS-917 is a prodrug of an orally active, potent and selective inhibitor of fructose-1, 6-bisphosphatase (FBPase), a regulatory enzyme in the pathway responsible for the production of glucose in the liver, known as the gluconeogenesis pathway. By specifically inhibiting this pathway, liver glucose production should be reduced and blood sugar levels decreased in patients with diabetes, independent of insulin levels, body weight and disease stage. Metabasis believes that CS-917 is the first product candidate to be studied in human clinical trials that is designed to directly block this pathway.<<
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Still on track for reporting in the first half, I'd say, but the stock is not moving at all on the news. I remember now why I was asking if anybody had a feel: there are no recent webcasts. Shoot, Gilead archives some of their webcasts for a year. Is MBRX really that short of mass data storage? Webmaster on sabbatical? The JP Morgan webcast they archive is simply a link to the JP Morgan website, so that you have to be a JP Morgan client to listen it. Sheesh. Hey, Dr. Laikind, little help here, please. Given their attitude about archiving, I'll be sure to catch the next one quickly.
Cheers, Tuck |
