AC IMMUNE PARTNER GENENTECH PRESENTS IMPORTANT DATA ON ALZHEIMER'S THERAPY CRENEZUMAB
AC IMMUNE PARTNER GENENTECH PRESENTS IMPORTANT DATA ON ALZHEIMER'S THERAPY CRENEZUMAB
- Crenezumab higher dose in CREAD Phase 3 Alzheimer's trial supported by exposure-response model
- Phase 1b dose-escalation study results support 60mg/kg dose in CREAD Phase 3
Lausanne,
Prof.
About the crenezumab drug-disease progression model
Genentech has developed a comprehensive drug-disease progression model to simulate the Phase 3 clinical trial and estimate the likelihood of achieving relative reduction in disease progression in patients treated with different doses of crenezumab, in different patient populations. The drug-disease model adequately described the historical longitudinal decline in ADAS-Cog 12[1] and CDR-SB[2] in mild to moderate AD patients of crenezumab in Phase 2 studies (
The clinical trial simulations using the drug-disease model predict a meaningful response of crenezumab in patients with mild AD at a dose of 60mg/kg IV every 4 weeks, as measured by CDR-SB and ADAS-Cog 12. This dose of 60mg/kg IV was selected by Genentech for the Phase 3 CREAD trial, which started recruitment of patients in Q1 2016.
About the Phase 1b study results
Genentech presented the results of the first two cohorts of the Phase 1b crenezumab dose escalation study (NCT02353598) in 52 patients with mild-to-moderate Alzheimer's disease. No dose-limiting toxicities were observed at 30, 45 and 60mg/kg doses of crenezumab. No events of Amyloid Related Imaging Abnormality-Edema (ARIA-E) were observed in the Phase 1b study and only a few patients (6 of 52) showed asymptomatic Amyloid Related Imaging Abnormality-Hemsiderin(ARIA-H) which did not result in treatment discontinuation. The pharmacokinetic profile of crenezumab is dose proportional up to the 60mg/kg dose and is consistent with historical data. The serum concentrations at this dose are four fold higher than in the 15mg/kg IV every four weeks dose used in the Phase 2 trials. These safety and pharmacokinetic data of the Phase 1b dose escalation study support the continued treatment of patients with crenezumab at a higher dose of 60mg/kg.
About Crenezumab
Crenezumab was discovered by
Genentech is currently evaluating the clinical efficacy and safety of crenezumab in a Phase 3 clinical trial, CREAD, in 750 participants with prodromal or mild Alzheimer's disease, which started in Q1 2016 and is expected to read out in 2020. In addition crenezumab was chosen by an international panel of experts, including the
About Alzheimer's disease
It is becoming increasingly clear that Alzheimer's disease develops because of a complex series of events that take place in the brain over a long period of time. Two proteins - Tau and beta-amyloid (Abeta) - are recognized as major hallmarks of neurodegeneration: tangles and other abnormal forms of Tau protein accumulate inside the brain cells and spread between cells, while plaques and oligomers formed by beta-amyloid occur outside the brain cells of people with AD.
AD is one of the biggest burdens of society with a dramatic and growing worldwide incidence rate of one new case every three seconds, or 9.9 million new cases of dementia each year. Since the incidence and prevalence of AD increase with age, the number of patients will grow significantly as society ages. Worldwide in 2015 there are 46.8 million people living with dementia and by 2050 it is expected that global patient numbers will triple to 131.5 million. It is estimated that the annual societal and economic cost of dementia has risen from
About
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For further information please contact:
| Prof. Andrea Pfeifer Chief Executive Officer Phone: +41-21-345 91 21 E-mail:andrea.pfeifer@acimmune.com |
Eva Schier Corporate Communications Manager Phone: +41-21-345 91 34 Mobile: +41 79 926 66 03 E-mail: eva.schier@acimmune.com |
| Nick Miles/ Toomas Kull Cabinet Privé de Conseils s.a. Phone : +41 22 321 45 40 E-mail : miles@cpc-pr.com kull@cpc-pr.com |
In the US Ted Agne The Communications Strategy Group Inc. Phone: +1 781 631 3117 E-mail: edagne@comstratgroup.com |
[1] ADAS-Cog 12: Alzheimer's Disease Assessment Scale-cognitive subscale ADAS-cog is a widely used scale in clinical trials which measures the patient's performance on tests of memory and other areas of cognition, especially orientation, praxis and language.
[2] CDR-SB: Clinical Dementia Rating Scale Sum of Boxes is an assessment of an overall function of the patient in daily life. The patient's performance in the six domains of memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care are assessed by interviewing the patient and caregiver.