H. Lundbeck’s Phase III Data Crushes Hope for Alzheimer’s Once Again
September 23, 2016
By Alex Keown, BioSpace.com Breaking News Staff
VALBY, Denmark – Once again the dreaded Alzheimer’s disease has eluded a drugmaker’s attempt to defeat the memory-fragmenting disease. Danish company H. Lundbeck A/S (LUN.CO) announced this morning its experimental Alzheimer’s treatment, idalopirdine failed in a late stage trial.
Lundbeck announced Thursday afternoon that both doses being studied in the Phase III trial showed an “a weak efficacy profile” and failed to meet primary and secondary endpoints. The Phase III trial failed to demonstrate the promising results that an earlier Phase II trial showed.
“We are disappointed about the outcome of this study,” Anders Gersel Pedersen, Lundbeck’s chief scientific officer, said in a statement. “The phase II data were very encouraging but unfortunately, these data failed to replicate those findings.”
Idalopirdine is a selective 5-HT6 receptor antagonist. The 5-HT6 receptor is expressed in brain regions involved in cognition, such as the cortex and the hippocampus, and modulates activity of multiple neurotransmitter systems.
Lundbeck is developing idalopirdine along with Japan’s Otsuka Pharmaceutical Co. Ltd., the company said in a statement. Although idalopirdine showed “weak efficacy,” Lundbeck said the drug was safe and well-tolerated.
Finding a cure for Alzheimer’s has been a monumental struggle for pharmaceutical companies. As companies look for a cure or therapy, researchers are taking different approaches to tackling the dread disease. Lundbeck’s idalopirdine was believed to modulate the balance between excitation (glutamate) and inhibition (GABA) in the brain. Other developmental drugs target the buildup of amyloid plaque, which many researchers believe is the cause of Alzheimer’s. Earlier this year, New York-based Anavex Life Sciences Corp. (AVXL) reported anecdotal evidence its drug, Anavex 2-73, was showing positive response in a mid-stage trial. Two patients who were administered the drug were able to regain control of some motor functions and memories, including the abilities to play piano and paint. Although the results were miniscule, they were promising.
Alzheimer’s disease, a type of dementia, affects 15 million people worldwide, a number that is expected to grow to 75 million by 2030 due, in part, to the lack of effective treatments. In total, there are about 50 million people suffering from some form of dementia worldwide. There are currently no drugs that target the cause of Alzheimer’s the most common form of dementia. There are several drugs on the market that help manage Alzheimer’s, but none treat the primary cause, including Eisai Co. (ESALF.PK)’s Aracept.
Lundbeck said that although the Starshine study failed, the company is continuing with two other late-stage studies, Starshine and Starbright. Data from those trials is expected to be available in the first quarter of 2017, the company said in a statement.
Idalopirdine is not the only drug Lundbeck has co-developed with Otsuka. The two companies teamed up to develop Rexulti, a therapy for adults battling depression as well as for adults battling schizophrenia.
Last year Lundbeck eliminated 1,000 positions as the company faced the challenges of generic medications. At the time the company announced the job cuts, Lundbeck had seen approximately a seven percent decline in revenue due to generic competition for its antidepressant Cipralex and Alzheimer’s treatment Ebixa.
Other key products in Lundbeck’s pipeline include Abilify Maintena, Brintellix, Northera and Onfi.