Metabasis Therapeutics Inc. says it will look to find a partner to advance its experimental diabetes drug following studies that showed the therapy safe and effective in a midstage human trial.
The second generation drug, MB07803, targets a key enzyme to control production of excess blood sugar in the liver. The 28-day study involved 105 patients with type 2 diabetes.
Study results, released April 28, showed first-time evidence of a reduction in glucose levels using MB07803.
Metabasis Chief Executive Officer Paul Laikind says the most recent findings should help the company find a development partner to push the drug forward.
In July, Metabasis was hit with a pair of setbacks, sending its stock price down, with shares losing more than half their value. Schering-Plough Corp. told the company it was pulling out of a collaboration to develop a new hepatitis B therapy, and its first generation diabetes drug failed to prove efficacy in a clinical trial.
MB07803 was developed as an improved diabetes drug following the setback.
“We were enthusiastic to find out whether preclinical data would translate into clinical data, and it did,” Laikind said. “There are no other drugs on the market today that work through this same mechanism.”
Most work to target insulin, the hormone responsible for glucose levels, but Laikind says that some therapies lose their effect over time.
“Even though we do have quite a number of drugs to treat patients with type 2 diabetes, it still is a poorly treated disease,” Laikind said. “There’s still room for considerable improvement.”
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FDA Wants More Info From Isis: Shares of Carlsbad-based Isis Pharmaceuticals Inc. sank April 25 following the FDA’s request for additional data demonstrating that its experimental cholesterol-lowering drug does not cause cancer.
Shares of Isis, traded on Nasdaq under the symbol ISIS, fell $4.81, or 29 percent, closing at $11.99.
Isis and its Cambridge, Mass.-based partner, Genzyme Corp., are developing the drug, mipomersen, to treat a severe form of high cholesterol called homozygous familial hypercholesterolemia.
The FDA’s request will delay the time it takes the companies to file a new drug application by about a year. They had originally intended to file in late 2009, but the additional data could delay the application until 2010.
Analysts pointed to back-to-back refusals of Isis’ mipomersen and another cholesterol drug made by Merck & Co. Inc. as a worrisome trend that could make it tougher on companies to win approvals for cholesterol drugs.
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