AstraZeneca och Lilly meddelar att man fortsätter in i Fas III med läkemedel mot tidig Alzheimer
AstraZeneca och Lilly meddelar att resultatet i AMARANTH, en fas II/III studie med AZD3293, en peroral beta secretase cleaving enzyme (BACE) inhibitor, som är under utveckling som möjlig behandling för begynnande Alzheimer´s sjukdom kommer att fortsätta in i fas III.
Phase II/III trial of AZD3293, an oral potent small molecule BACE inhibitor, will continue to Phase III after positive interim safety data
The AMARANTH independent data monitoring committee recommended the study continue without modification after a scheduled interim safety analysis was conducted. The analysis was not designed to review efficacy.
Menelas Pangalos, Executive Vice President, IMED Biotech Unit, AstraZeneca, said: “Alzheimer’s disease remains one of the biggest challenges facing medical science today. 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.”
AZD3293 has been shown in Phase I studies to reduce levels of amyloid beta in the cerebro-spinal fluid of people with Alzheimer’s disease and healthy volunteers. The progression of Alzheimer’s disease is characterised by the accumulation of amyloid plaque in the brain. BACE is an enzyme associated with the development of amyloid beta. Inhibiting BACE is expected to prevent the formation of amyloid plaque and eventually slow the progression of the disease.
Phyllis Ferrell, vice president and global development leader for Alzheimer’s disease at Lilly said: “This is an important and meaningful step forward on the path to better understand the Alzheimer’s puzzle. We’d like to thank the AMARANTH participants and the trial investigators for taking part in this important study and thank our colleagues at AstraZeneca for their partnership.”
AstraZeneca and Lilly have also announced the planned initiation of a new Phase III trial for AZD3293. The trial, named DAYBREAK, will study the safety and efficacy of AZD3293 in people with mild Alzheimer’s dementia. DAYBREAK will begin enrolling participants in the third quarter of 2016.
AstraZeneca and Lilly announced an alliance in 2014 for the development and commercialisation of AZD3293/LY3314814. Under the agreement, Lilly leads clinical development, working with researchers from AstraZeneca’s Neuroscience Research and Development Team, while AstraZeneca will be responsible for manufacturing. The companies will take joint responsibility for commercialisation of the molecule and will share all future costs equally for development and commercialisation, as well as net global revenues post-launch.
Inlägget AstraZeneca och Lilly meddelar att man fortsätter in i Fas III med läkemedel mot tidig Alzheimer dök först upp på Neurologi i Sverige.