Med Check

Lundbeck announced May 29 that its investigational compound LuAE58054 met its primary endpoint in a fixed dose, randomized, placebo-controlled study in 278 patients with Alzheimer’s disease. LuAE58054 is a novel, selective 5HT6 receptor antagonist. Augmentation therapy with LuAE58054 (plus 10 mg/day donepezil) at the selected dose resulted in statistically significant improvement in cognition, as measured by the Alzheimer’s Disease Assessment Scale-cognitive subscale over a 24-week treatment period versus placebo (plus 10 mg/day donepezil). Secondary endpoints, including measures of global status and activities of daily living, also showed positive trends with the addition of LuAE58054, compared with donepezil. The study was conducted in several European countries as well as Canada and Australia.

On June 1, Eli Lilly and its subsidiary, Avid Radiopharmaceuticals, announced limited availability of Amyvid (florbetapir F 18 injection) , a radioactive drug that binds to brain beta-amyloid and is detected by positron emission tomography (PET) to produce images of the amyloid neuritic plaques in the brains of individuals who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.

Amyvid is available to imaging centers in markets surrounding 16 manufacturing sites throughout the United States. Because Amyvid loses over half of its radioactivity every two hours, it must be distributed directly to imaging centers from the specialized radiopharmacies where it is produced. Lilly advises patients to speak to their health care provider to determine if Amyvid is an appropriate option and to determine if it is available in their area.

Lilly also announced the launch of its online reader training program at AmyvidTraining.com. Lilly and Avid also collaborated with the American College of Radiology to present a training program, which was launched on June 11 in Miami. The reader training programs were developed to provide training for radiologists and nuclear medicine physicians who will be responsible for reading Amyvid scans. The manufacturers cautioned that Amyvid images should be interpreted only by readers who have successfully completed the reader training. Errors may occur in the estimation of plaque density during image interpretation.

For more information about Amyvid, see the June 1 Psychiatric News.

Nektar Therapeutics said June 7 that regulators are giving fast-track status to its experimental pain drug NKTR-181. Designed to treat moderate to severe chronic pain, NKTR-181 may be less likely to be abused than other pain medications because it takes effect on the brain slowly.

The fast-track designation allows Nektar to submit its marketing application to the Food and Drug Administration (FDA) piece by piece instead of having to file all the paperwork at once. It also allows for more frequent interaction with the agency and a possible priority review.

Nektar said it plans to start a mid-stage trial of NKTR-181 in July. The trial will test the drug’s safety and effectiveness in treating chronic pain caused by osteoarthritis of the knee. It is also planning a study that will evaluate the drug’s potential for abuse.

AC Immune announced June 18 that it has entered into a second exclusive worldwide license agreement and research collaboration with Genentech for the research, development, and commercialization of AC Immune’s anti-Tau antibodies for the potential treatment of Alzheimer’s disease and other neurodegenerative diseases.

Under the multiyear research collaboration, AC Immune will work in partnership with Genentech to identify and formulate several preclinical candidates. Genentech will have global responsibility for preclinical and clinical development, manufacturing, and commercialization of antibodies resulting from the collaboration.

Genentech is currently evaluating the anti-Abeta antibody crenezumab in a phase 2 clinical study in Alzheimer’s patients with mild to moderate symptoms. In May 2012, crenezumab was selected to be tested in the first-ever prevention trial in healthy individuals who are genetically at risk for developing Alzheimer’s disease.

On June 13, Merck announced data from two pivotal phase 3 efficacy trials for suvorexant . In the studies, suvorexant significantly reduced the time it took patients to fall asleep and increased the time that patients stayed asleep as early as the first night and at the three-month time point compared with placebo. The data were presented at SLEEP 2012, the annual meeting of the Associated Professional Sleep Societies.

The most common adverse events reported at an incidence of greater than or equal to 5 percent and more often than placebo were sleepiness and headache. Other data presented at the meeting included results that showed the effects of suvorexant after daily dosing for at least a year and results from a driving study in elderly patients. Merck plans to present additional results from its two pivotal phase 3 efficacy trials later this year.

Merck said it plans to file a New Drug Application for suvorexant with the FDA in 2012. If approved, it would be the first medicine approved in a new class of medications called orexin receptor antagonists, for use in patients with difficulty falling or staying asleep.

Takeda announced June 8 that it has finalized a contract to transfer TAK-070, previously developed by Takeda as a treatment of Alzheimer-type dementia, to the National University Corporation, the University of Tokyo.

TAK-070 was discovered by Takeda and acts to inhibit the β-secretase enzyme. Amyloid-β-protein is postulated as a fundamental cause of Alzheimer’s-type dementia and is produced by the action of β-secretase on amyloid-β-precursor protein. TAK-070 is thought to suppress the production of amyloid-β protein by inhibiting this β-secretase.

“Although we chose not to continue the clinical development of TAK-070, Takeda is eager to use all our molecules in any way that can bring benefit to patients, and we believe that transferring TAK-070 to University of Tokyo Hospital is a great way of doing this,” said Paul Chapman, a general manager of the Pharmaceutical Research Division of Takeda.