Eli Lilly and Company and AstraZeneca have agreed to continue studies into AMARANTH, a phase 3 of the phase 2/3 trial of AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor being developed as a potential treatment for early Alzheimer’s disease.
The independent data monitoring committee of AMARANTH has suggested that the study should be continued without modification after conducting a planned interim safety analysis, which was not designed to review efficacy.
In the phase 1 studies, AZD3293 has been demonstrated to decrease levels of amyloid beta in the cerebro-spinal fluid of people with Alzheimer’s and healthy volunteers.
Progression of Alzheimer’s disease is characterised by accumulation of amyloid plaque in the brain and BACE, which is an enzyme linked with development of amyloid beta.
Inhibiting BACE is expected to stop the formation of amyloid plaque and ultimately slow the progression of the disease.
AstraZeneca IMED biotech unit executive vice-president Menelas Pangalos said: "Alzheimer’s disease remains one of the biggest challenges facing medical science today.
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"BACE inhibitors have the potential to target one of the key drivers of disease progression and we are delighted that our combined efforts have resulted in the development of AZD3293 moving into the next phase of study.
"Disease-modifying approaches, such as this, have the potential to transform the treatment of Alzheimer’s disease and help patients in this area of large unmet medical need."
In addition, Lilly and AstraZeneca have announced the scheduled initiation of phase 3 trial for AZD3293.
The new trial, called DAYBREAK, will study the safety and efficacy of AZD3293 in people with mild Alzheimer’s dementia, and will start enrolling participants in the third quarter of this year.
In 2014, both companies announced a collaboration for development and commercialisation of AZD3293/LY3314814.
Under the deal, AstraZeneca will now get a payment from Lilly.
Under the contract, Lilly leads clinical development, working with researchers from AstraZeneca’s neuroscience research and development team, while AstraZeneca will be responsible for manufacturing.