CLAIM #36698 · Eli Lilly and Company (LLY) · 2023Q1 earnings call · Apr 27, 2023 · due Jun 30, 2023
“Of course, we expect the next key milestone for genenumab will be later this quarter when we obtain the results for our confirmatory Phase III TRAILBLAZER ALS 2 trial.”
Dr. Dan Skovronsky · Chief Scientific and Medical Officer
In context
“sease in late March. For denetimab, we shared data from our Trailblazer EXT, a Phase II long-term follow-on study of Trailblazer ALS. While study limitations include a relatively small number of patients, the data showed encouraging trends and the longer-term effects on amyloid and tau levels and clinical progression. We also disclosed the trial design and objective for Trailblazer Phase IIIb study to expand the science and understanding of ARIA in relationship to amyloid lowering through imaging and blood-based biomarkers in different dosing paradigms. This study will leverage enhanced MRI sequences as well as blood-based biomarkers and other patient characteristics that may predict ARIA. And we'll investigate the effect of different dosing regimens on the frequency and severity of ARIA. Of course, we expect the next key milestone for genenumab will be later this quarter when we obtain the results for our confirmatory Phase III TRAILBLAZER ALS 2 trial. We look forward to sharing these results and to advancing the regulatory process for assuming positive data from this trial. This quarter, we also shared the first clinical data from [indiscernible] from a Phase I multiple ascending dose study, which highlighted the potential speed and depth of amyloid plaque lowering in patients with Alzheimer's disease. These data on amyloid clearance, safety and tolerability supported our decision to move this asset into Phase III, and we look forward to sharing further updates as the program progresses. You'll also notice we have a number of developments in our early-stage neuroscience portfolio with a Phase II entry for our GBA1 gene therapy asset in the Gaucher disease type 1 indication along with 2 Phase I pain asset entries and 1 Phase II pain ass”
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SEC filings for LLY ↗ · Claim quote is verbatim from the 2023Q1 earnings call.