Update on Phase 3 Clinical Trials of Lanabecestat for Alzheimer's Disease
"The complexity of Alzheimer's disease poses one of the most difficult medical challenges of our time, and we are deeply disappointed for the millions suffering from this devastating disease," said
The IDMC recommendation to stop the studies was not based on safety concerns.
"We are saddened by this outcome as our researchers are working tirelessly to find a solution for the many people who are impacted by this devastating disease," said Menelas Pangalos, Ph.D., Executive Vice President, IMED Biotech Unit,
The AMARANTH trial randomized patients with early Alzheimer's disease to receive lanabecestat, 20mg or 50mg, or placebo orally once daily for 104 weeks. The primary endpoint of the trial was change from baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13). Early Alzheimer's disease is defined as the continuum of patients with mild cognitive impairment due to Alzheimer's disease and patients diagnosed with mild Alzheimer's dementia. Patients who completed the AMARANTH trial were given the opportunity to enroll in the AMARANTH extension trial, where all patients received active treatment.
The DAYBREAK-ALZ trial randomized patients with mild Alzheimer's disease dementia to receive lanabecestat, 20mg or 50mg, or placebo orally once daily for up to 156 weeks. The primary endpoint of the trial was change from baseline on ADAS-Cog13.
Lilly does not anticipate significant costs associated with this decision and is reaffirming both its financial guidance for 2018 and its mid-term guidance for the remainder of this decade.
About Alzheimer's Disease
Alzheimer's disease is a fatal illness that causes progressive decline in memory and other aspects of cognition.1 Dementia due to Alzheimer's disease is the most common form of dementia, accounting for 60 to 80 percent of all cases.2 There are currently an estimated 50 million people living with dementia around the world, with numbers expected to increase to nearly 75 million by 2030 and 132 million by 2050. Almost 10 million new cases of dementia are diagnosed each year worldwide, implying one new case approximately every 3 seconds. The current total annual societal and economic estimated cost of dementia is
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