Lilly's Big Alzheimer's Bet Solanezumab
Solanezumab is a monoclonal antibody existence studied equally a potential therapy for Alzheimer's disease.
Baca Juga
In addition, pre-specified secondary subgroup analyses of pooled information across both studies showed a statistically pregnant slowing of cognitive reject inward patients amongst mild Alzheimer's disease, but non inward patients amongst moderate Alzheimer's disease.
| Subscribe to the |
Eli Lilly too Company Announces Top-Line Results on Solanezumab Phase three Clinical Trials inward Patients amongst Alzheimer's Disease
Adverse events amongst an incidence of at to the lowest degree 1 per centum that occurred statistically significantly to a greater extent than inward the solanezumab grouping than inward the placebo grouping were lethargy, rash too malaise (in EXPEDITION1) too angina (in EXPEDITION2).
An ongoing, open-label extension study, EXPEDITION-EXT, is fully enrolled too volition travel along equally planned.
"We recognize that the solanezumab studies did non reckon their primary endpoints, but nosotros are encouraged past times the pooled information that appear to present a slowing of cognitive decline," said John C. Lechleiter, Ph.D., chairman, president too primary executive officer, Lilly. "We intend to hash out these information amongst regulatory regime to make their insights on potential adjacent steps."
"Lilly is committed to finding medicines that alteration the underlying pathology of Alzheimer's affliction for the create goodness of patients too their loved ones," said January Lundberg, Ph.D., executive vice president, scientific discipline too technology, too president, Lilly Research Laboratories. "We believe the pooled information back upwards the amyloid hypothesis, equally these are the start Phase three information amongst an anti-beta amyloid agent that appear to present a slowing of cognitive decline."An independent analysis of the information from the EXPEDITION studies is existence performed past times the Alzheimer's Disease Cooperative Study (ADCS), an academic national enquiry consortium that facilitates the discovery, evolution too testing of novel drugs for the handling of Alzheimer's disease.
ADCS volition acquaint their findings at the American Neurological Association (ANA) coming together inward Boston, Mass., on Oct 8, 2012, too at the Clinical Trials on Alzheimer's Disease (CTAD) coming together inward Monte Carlo, Monaco, on Oct 30, 2012.
The adjacent steps for solanezumab accept non yet been decided too volition live on determined later on discussions amongst regulators.
About the clinical lawsuit endpoints for the EXPEDITION studies
The EXPEDITION1 report did non reckon co-primary cognitive too functional endpoints inward the overall mild-to-moderate patient population; however, pre-specified secondary subgroup analyses inward patients amongst mild Alzheimer's affliction showed a statistically pregnant reduction inward cognitive decline.
Based on those results, Lilly modified the statistical analysis project design (SAP) for EXPEDITION2 prior to database lock to specify a unmarried primary endpoint of knowledge inward the mild patient population. This revised primary endpoint did non laissez passer statistical significance. In both of the EXPEDITION report protocols, mild Alzheimer's affliction was defined equally a baseline Mini-Mental Status Examination (MMSE) marking of xx to 26 too moderate Alzheimer's affliction was defined equally a baseline MMSE marking of sixteen to 19.
About solanezumab too the EXPEDITION studies
Solanezumab is a monoclonal antibody existence studied equally a potential therapy for Alzheimer's disease.
The two, Phase three double-blind, placebo-controlled solanezumab EXPEDITION clinical trials included to a greater extent than than 2,050 patients amongst mild-to-moderate Alzheimer's affliction inward sixteen countries simply about the world. The trials were 18-months inward duration.
About Alzheimer's disease
Alzheimer's disease, the most mutual shape of dementia, causes progressive reject inward retentivity too other aspects of cognition.(1),(2) Researchers create non know precisely what causes Alzheimer's affliction too at that topographic point are currently no approved treatments shown to ho-hum the progression of this devastating disease, alone handling options that cut down for certain symptoms of the disease.
About Eli Lilly too Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products past times applying the latest enquiry from its ain worldwide laboratories too from collaborations amongst eminent scientific organizations. Additional information near Lilly is available at www.lilly.com.
This press unloose contains for certain forward-looking statements near solanezumab. This unloose reflects Lilly's electrical flow beliefs; however, equally amongst whatever pharmaceutical product, at that topographic point are substantial risks too uncertainties inward the procedure of evolution too commercialization.
SOURCE Eli Lilly too Company
- Why Do Alzheimer's Caregivers Torture Themselves?
- Alzheimer's Disease Statistics
- What is the Difference Between Alzheimer’s too Dementia
- Dementia too the Eight Types of Dementia
- Test Your Memory for Alzheimer's (5 Best Tests)
- Alzheimer's too the Importance of Thinking Positive
- Why Do the Deeply Forgetful Say No So Often
Original content the