National Editor

Saegis Pharmaceuticals Inc. was granted an exclusive license to develop and market its lead Alzheimer's disease candidate, SGS742, from Novartis Pharma AG, which got an equity stake in Saegis as part of the deal.

"The whole key is having drugs with efficacy that are very safe," said Rodney Pearlman, president and CEO of Saegis, located in Half Moon Bay, Calif.

Existing cholinesterase inhibitors, such as Aricept (donepezil) from New York-based Pfizer Inc., "are all good drugs but often the efficacy is limited by nausea and vomiting," since the drugs work not just in the brain, but all over the body.

A treatment that could be dosed higher might work better, and Saegis is advancing the GABA-B receptor antagonist SGS742 with that hope.

In 2001, Basel, Switzerland-based Novartis granted Saegis an option to an exclusive license on SGS742, and Saegis went on to complete a Phase II trial of the compound in mild cognitive impairment (MCI), which is age-related memory loss that often precedes Alzheimer's. (See BioWorld Today, Aug. 20, 2002.)

Saegis next is getting under way a Phase II trial of SGS742 in mild to moderate Alzheimer's disease. In November, the privately held firm raised $30 million in an equity financing to push SGS742 and other candidates. (See BioWorld Today, Nov. 19, 2003.)

Founded in 1999 and formerly known as David Pharmaceuticals Inc., the company in-licensed three compounds in 2000 and 2001, two (called DVD742 and DVD006 at the time) from Novartis and one (called DVD111) from the Russian Academy of Medical Science.

The company said in November it was completing a Netherlands-based Phase II trial of DVD111 in age-related cognitive decline, along with the Phase II trial of DVD742 for MCI in the United States. Both are finished.

DVD742 eventually was renamed SGS742.

The drug "works for MCI, but it's very difficult to get approval because there's no path to approval [for that indication] yet," Pearlman said, so the company will pursue the Alzheimer's indication first instead.

DVD006 is "sitting on the shelf," and is not being developed further, Pearlman said. DVD111 yielded "different answers from what we hoped" in the Phase II study, and will be pursued in moderate to severe Alzheimer's, as well as cognitive deficits associated with coronary artery bypass graft surgery, he said.

Another drug, in-licensed from Eli Lilly and Co., of Indianapolis, is SGS518. It is expected to enter the clinic this year for cognitive deficit associated with schizophrenia, where a "huge opportunity" exists, Pearlman told BioWorld Today.

Available drugs deal with the effects of schizophrenia, such as hallucinations and psychoses, but there are no drugs yet approved to deal with cognitive deficit related to the disease, he said.

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