(^22) ANALYSIS BIOSPECTRUM | SEPTEMBER 2018 | http://www.biospectrumindia.com
symptoms of the disease gradually worsen over a
number of years. This disease has no current cure;
there are drugs that only treat symptoms and these
drugs are highly patient dependent.
For the pharma industry, it’s been a bumpy ride to
fight Alzheimer’s disease. Alzheimer’s is a formidable
foe for a number of reasons. The brain isn’t easy to
access, animal models for testing are difficult and it
is estimated that nearly 99.6 per cent of the clinical
trials have failed in the course of 2002 to 2012. A
recent study looked at how 244 compounds in 413
clinical trials fared for Alzheimer’s disease between
2002 and 2012. The study findings paint a gloomy
picture. Of those 244 compounds, only one was
approved.
Despite this sky-high failure rate, pharmaceutical
companies are leaving no stone unturned to find a
cure for this debilitating disease, presumably because
of the lucrative and largely untapped drug market.
Wall Street thinks that a medicine for Alzheimer’s
could rake in a monstrous $20 billion in sales by
2030, given that over 5 million Americans already
suffer from this debilitating disease, combined with
the fact that there are no treatments available right
now.
In the past decade or two, global drug
powerhouses like Eli Lilly, Eisai, Roche, Pfizer,
AstraZeneca, Biogen, and Merck have devoted
billions of dollars into projects. Among this diverse
list of clinical hopefuls, Eli Lilly and Biogen’s beta-
amyloid plaque-busting antibodies -- solanezumab
and aducanumab, respectively -- have garnered the
most attention, in part because of the advanced state
of their development. While the lucrative market is
attracting pharma companies, so is repeated failures
and billions of dollars spent, prompting several
pharma giants to end their research efforts towards
finding a cure for the disease.
2018 began with pharma giant Pfizer announcing
that it was ending its internal efforts to develop new
drugs for Alzheimer’s and Parkinson’s diseases.
Axovant Sciences also announced that it is pulling
plug off its Alzheimer’s drug after a key study failure.
These setbacks pile on to an already depressing
situation: more than 400 failed clinical trials since
the last Alzheimer’s drug — which only treats
the symptoms of the disease, temporarily — was
approved more than a decade ago.
“I was surprised, because I knew Pfizer had
interesting compounds in the pipeline,” said Dr. Jeff
Cummings, director of the Cleveland Clinic Lou Ruvo
Center for Brain Health in Las Vegas as quoted by
the CNBC. For Cummings, though, it was ultimately
just one more addition to a long record he has
maintained, documenting the failure of Alzheimer’s
treatments. “It is another statement that development
of drugs, particularly for neurodegenerative diseases
like Alzheimer’s and Parkinson’s, has proven to be
enormously difficult.”
It takes on average 13 years for a candidate for
Alzheimer’s treatment to move from laboratory
to Food and Drug Administration (FDA) review
and 10 years for an agent to navigate the clinical
development period from start of phase I to end of
FDA review, elaborates a recent study. This means
that under current circumstances, an agent must
now be in phase II to possibly be approved by 2025.
Although there are few promising agents in the
clinical trial pipeline with the high rate of failure
of Alzheimer’s disease drug development, the aim
of having a repertoire of agents that could respond
comprehensively and individually to a patient’s
clinical circumstances within the 2025 timeframe
is not easy. Also, Alzheimer’s patients are generally
diagnosed in the late stage, mostly due to delayed
appearance of symptoms. Hence, developing the early
diagnostic devices that can detect the disease early is
also a significant challenge.
A new ray of hope
Amid these string of failures and trial closures,
comes Japan’s Eisai and Biogen’s announcement
bringing in hope to millions of patients. The
companies announced positive topline results
from the Phase II study with BAN2401, an anti-
amyloid beta protofibril antibody, in 856 patients
with early Alzheimer’s disease. The study achieved
statistical significance on key predefined endpoints
evaluating efficacy at 18 months on slowing
progression in Alzheimer’s Disease Composite
Score and on reduction of amyloid accumulated in
CURRENT CLINICAL TRIALS
FOR ALZHEIMER’S DISEASE
Global:
Phase 1: 25 drugs, 29 trials
Phase 2: 52 drugs, 68 trials
Phase 3: 28 drugs, 42 trials
Phase 4: 7 (i.e. these have successfully
completed Phase 3 testing).
Approximately 66 have been discontinued.
Europe:
Nine registered trials driven by large
pharmaceutical companies, such as Eli Lilly,
Hoffmann-La Roche, Janssen, Biogen, Eisai,
AZTherapies and Novartis.
Source: Vanessa Jane Hall
(http://sciencenordic.com - dated March 17, 2018)
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