First Biogen Inc, Now Roche Holding Ltd. : Rays Of Hope For An Alzheimer’s Cure

After Biogen’s success in slowing down Alzheimer’s progress in early-stage trials, Roche Holding intends to take its own Alzheimer’s candidate on a trial re-run

Roche Holding Ltd. (ADR) (OTCMKTS:RHHBY) is considering the initiation of a second trial to test its investigational Alzheimer’s drug that was abandoned in December after a disappointing initial study, Bloomberg reports. The move comes months after Biogen Inc (NASDAQ:BIIB) reported positive data for its own experimental Alzheimer’s med, BIIB037, which targets the same beta amyloid protein targeted by Roche’s gantenerumab.

The connection between dementia and abnormal protein deposits in the brain was made by the German psychiatrist Alois Alzheimer in 1902, and it was another 80 years later that beta amyloid protein was found to be a possible anti-Alzheimer’s target. No clinical trial has yet been able to reduce the protein in Alzheimer’s patients’ brains and simultaneously slow disease progression.

BIIB037 (aducanumab) is the first Alzheimer’s investigational drug that not only demonstrated a 71% reduction in cognitive decline at the highest dosage among 166 patients in an early-stage trial, compared to a placebo, but also reduced beta amyloid protein. According to Biogen’s chief medical officer Alfred Sandrock, the company will go past mid-stage trial for BIIB037 directly into final-stage testing.

The trials are set to start later this year and the company intends to test two drug doses, including a lower dosage in trial patients who have a genetic disposition to Alzheimer’s disease. Such patients demonstrated the most side effects in Biogen’s early-stage trial.

Paulo Fontoura, head of neuroscience clinical development at Roche, commented on Biogen’s Alzheimer’s data in an interview to Bloomberg: “Everyone was excited to see that data,” since it rekindled hopes in a beta-amyloid targeting cure for the disease. Roche now plans to re-run its own study of gantenerumab at a higher dosage and with certain other trial adjustments. Mr. Fontoura further said that a second trial will also be conducted for mild Alzheimer’s patients to check if chance of success can be increased.

“Dose is one of the key factors we are looking at now,” he said, adding: “The two molecules are remarkably similar. It’s more to do with how the experiment was set up.”

Mr. Fontoura was also of the opinion that Biogen’s trial results may have to be confirmed in larger studies since the current trial used a small sample size. “The Biogen data is a little bit of a surprise, because typically you need much larger sample sizes to see that much of a signal…In Alzheimer’s unfortunately we’re still in a world where we do need pretty large datasets to get a robust signal,” he said.

Interestingly, however, Biogen’s Alzheimer’s drug did present adverse side-effects in trial subjects especially the brain swelling termed as amyloid-related imaging abnormalities (ARIA). More than half of Biogen’s trial patients with genetic mutation favoring Alzheimer’s disease suffered through ARIA while one third was forced to discontinue treatment due to it. Roche hopes to establish its own drug as both are safe and efficient in treating Alzheimer’s disease.

Alzheimer’s disease is a progressive deterioration of brain function, leading patients to an eventual memory loss. There are currently 47.5 million patients of the disease, including other form of dementia worldwide, and the number is expected to nearly double by 2030, as per the World Health Organization (WHO). WHO further estimated that the healthcare cost of dementia worldwide came up to $600 billion in 2010.

The fact that further expands the market opportunity of an Alzheimer’s medicine is that the disease has no worthwhile approved treatments as yet. The available drugs do not cure but only serve to relieve patients of certain disease symptoms such as declining cognitive function and even the benefits are short-term.

The currently available drugs include Eisai Co., Ltd’s (ADR) (OTCMKTS:ESALY) Aricept, which raked in nearly $2.7 billion in sales in 2010 before losing US patent protection the same year. Moreover, a 2014 study published in Alzheimer’s Research UK revealed that 244 Alzheimer’s drugs were tested between 2002 and 2012, out of which only one got approved – Lundbeck A/S’s Ebixa.

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