Alzheimer's trials launched in Europe: Neurochem

Alzhemed is Neurocem's investigational product candidate for the treatment of Alzheimer's disease (AD). There are 73 centres in ten countries which have been selected by Neurochem to conduct the trial, of which many are centres of excellence of the European Alzheimer's Disease Consortium (EADC), the company announced in a press release.

The multi-centre, randomized, double-blind, placebo-controlled and parallel designed European phase III clinical trial will investigate the safety and efficacy of Alzhemed in treating AD, with some 930 mild-to-moderate AD patients taking part in the trial. They will be randomized to receive either placebo or one of two different dose levels of Alzhemed for a period of 18 months, in addition to their regular treatment with one of a number of acetylcholinesterase inhibitors.

In July, Neurochem completed the enrolment of 1052 mild-to-moderate AD patients for its North American phase III clinical trial on Alzhemed. To date, approximately 470 and 210 patients have completed six and nine months of the North American trial, respectively. Both the European and North American trials are designed to demonstrate the disease-modifying potential of Alzhemed.

Alzhemed's good tolerability profile and unique mechanism of action aimed at stopping the progression of the disease rather than targeting the symptoms are particularly interesting. The enthusiasm evidenced by the large attendance at our recent investigator meeting in Vienna for this phase III illustrates the European medical community's interest in and the excitement about participating in this trial, a company release said. 

Azhemed is an orally administered, small organic molecule specifically designed to modify the course of AD by binding to soluble amyloid ß (Aß) protein and keeping it in a non-fibrillar form. As reported previously, results of the phase II trial demonstrated that there were no apparent safety findings of concern in patients treated with Alzhemed and that the investigational product candidate was well tolerated in individuals with mild-to-moderate AD. 

Alzheimer's Disease (AD) is a progressive form of dementia associated with specific brain pathologies. It impairs a person's cognitive and motor functions and gradually destroys the brain.

AD is the most common cause of dementia in our aging population. Almost 5 million individuals in the United States alone currently suffer from the condition. The U.S. Alzheimer's Association estimates that by 2025, over 22 million people worldwide will be afflicted.

According to a report commissioned by the U.S. Alzheimer's Association, AD costs American businesses approximately US$61 billion a year That price tag includesUS$24.6 billion for direct health care of Alzheimer's patients and US$36.5 billion to cover costs related to caregivers of AD patients, including lost productivity, absenteeism and worker replacement.

Neurochem is focused on the development of therapeutics for neurological disorders. The company's pipeline of proprietary, disease-modifying oral products addresses critical unmet medical needs. 1,3-propanedisulfonate (1,3PDS; Fibrillex) is designated as an orphan drug and a Fast Track Product candidate and is also part of an FDA Continuous Marketing Applications Pilot 2 programme. The phase II/III clinical trial of Fibrillex for the treatment of AA Amyloidosis was recently concluded. The company is in the process of submitting a New Drug Application (NDA) for Fibrillex that the FDA has agreed to file and review and 3APS (Cerebril), for the prevention of hemorrhagic stroke caused by Cerebral Amyloid Angiopathy, has completed a phase IIa clinical trial, the release said.

BY OUR PHARMA CORRESPONDENT