Biogen Inc. · NASDAQ:BIIB
Biogen — Technical Presentation (December 2016)
18 slides from Biogen's technical presentation, Dec 12, 2016
Slide 1: Aducanumab 24-Month Data From PRIME: Phase 1b Study in Prodromal or Mild Alzheimer's Disease
Interim analysis presented at CTAD 2016 Aducanumab 24-Month Data From PRIME: A Randomized Double-Blind, Placebo-Controlled Phase 1b Study in Patients With Prodromal or Mild Alzheimer’s Disease Vissia Viglietta,1 John O’Gorman,1 Leslie Williams,1 Tianle Chen,1 Ahmed Enayetallah,1 Ping Chiao,1 Christo
Slide 2: Disclosures
Interim analysis presented at CTAD 2016 Disclosures This study was funded by Biogena VV, JO, LW, TC, AE, PC, SBH, and AS are employees and shareholders of Biogen CH and RMN are employees and shareholders of Neurimmune aMedical writing support for this presentation was provided by Erin Bekes, PhD
Slide 3: Overview
Interim analysis presented at CTAD 2016 Overview Aducanumab is a human monoclonal antibody selective for aggregated forms of Aβ, including soluble oligomers and insoluble fibrils PRIME is an ongoing Phase 1b study assessing the safety, tolerability, PK and PD of aducanumab in patients with prodr
Slide 4: PRIME Study Design: Placebo-Controlled and LTE Periods
Interim analysis presented at CTAD 2016 • Randomization: 3:1 active: placebo within cohorts, fixed-dose cohorts stratified by ApoE ε4 status • Patients randomized to placebo or aducanumab 1 mg/kg in the placebo-controlled period were switched to aducanumab 3 mg/kg or titration in the LTE (“switchers
Slide 5: Timeline of Dose Administration and Key Assessments in PRIME
Interim analysis presented at CTAD 2016 Timeline of Dose Administration and Key Assessments in PRIME aSchedule of brain MRIs for fixed-dose cohorts (Arms 1-7) MRI, magnetic resonance imaging IV infusions every 4 weeks over 52 weeks (14 total) active or placebo IV infusions every 4 weeks over a total
Slide 6: Patient Disposition at 24 Months
Interim analysis presented at CTAD 2016 Dosed in placebo-controlled period Completed treatment in the placebo-controlled period 166 randomized (165 dosed) 1 mg/kg 31 Pooled placebo 40 3 mg/kg 32 6 mg/kg 30 10 mg/kg 32 2430 26 25 20 Patient Disposition at 24 Months Analysis of data from fixed-dose ar
Slide 7: Baseline Disease Characteristics: Placebo-Controlled Period
Interim analysis presented at CTAD 2016 Baseline Disease Characteristics: Placebo-Controlled Period SUVR, standardized uptake value ratio aCholinesterase inhibitors and/or memantine Placebo (n=40) Aducanumab 1 mg/kg (n=31) 3 mg/kg (n=32) 6 mg/kg (n=30) 10 mg/kg (n=32) ApoE ε4, n (%) Carriers Non-car
Slide 8: PET Amyloid Imaging
Interim analysis presented at CTAD 2016 PET AMYLOID IMAGING
Slide 9: Aducanumab Reduced Amyloid Plaque Burden Over 24 Months
-0.40 -0.30 -0.20 -0.10 0.00 0.10 Aducanumab Reduced Amyloid Plaque Burden Over 24 Months ** Nominal P<0.01; *** Nominal P<0.001 vs placebo in the placebo-controlled period and vs placebo switchers in the LTE period. Results based on MMRM, fitted with change from baseline as a dependent variable, an
Slide 10: Clinical Endpoints
Interim analysis presented at CTAD 2016 CLINICAL ENDPOINTS
Slide 11: Continued Slowing of Decline on CDR-SB Over 24 Months
Interim analysis presented at CTAD 2016 0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 Continued Slowing of Decline on CDR-SB Over 24 Months CDR‒SB is an exploratory endpoint. Results based on MMRM, fitted with change from baseline as a dependent variable, and included fixed effects for categoric
Slide 12: Continued Slowing of Decline on MMSE Over 24 Months
Interim analysis presented at CTAD 2016 -7 -6 -5 -4 -3 -2 -1 0 1 Continued Slowing of Decline on MMSE Over 24 Months *Nominal P<0.05 (vs placebo [Week 52] or placebo switchers [Weeks 76 and 108]) MMSE is an exploratory endpoint. Results based on MMRM, fitted with change from baseline as a dependent
Slide 13: Safety and Tolerability
Interim analysis presented at CTAD 2016 SAFETY AND TOLERABILITY
Slide 14: No New Safety Signals Identified in the First Year of the LTE
Interim analysis presented at CTAD 2016 Continuersb 3 mg/kg (N=26) 6 mg/kg (N=24) 10 mg/kg (N=19) Number with an AE (%) 18 (69) 22 (92) 15 (79) Number with an SAE (%) 2 (8) 6 (25) 3 (16) Number discontinuing treatment due to AE (%) 2 (8) 0 3 (16) No New Safety Signals Identified with Aducanumab in t
Slide 15: No Continuers Developed ARIA-E During the First Year of the LTE
Interim analysis presented at CTAD 2016 Patients with ≥1 post- baseline MRI ARIA-E,a n (%) ApoE ε4 carrier ApoE ε4 non-carrier Isolated ARIA-H, n (%) No Continuers Developed ARIA-E During the First Year of the LTE bPatients who were randomized to receive 3, 6, and 10 mg/kg were scheduled to receive
Slide 16: Discontinuations Due to ARIA-E During the First Year of the LTE
Interim analysis presented at CTAD 2016 Patients with ≥1 post- baseline MRI ARIA-Ea, n (%) Continued treatment, n (%) Same dose Reduced dose Discontinued treatment, n (%) 0 0 0 ApoE ε4 carriers 3 0 0 0 0 ApoE ε4 non-carriers 1 0 0 0 0 Discontinuations due to ARIA-E During the First Year of the LTE b
Slide 17: Summary
Interim analysis presented at CTAD 2016 Summary At 24 months, brain amyloid plaque burden continued to decrease in aducanumab continuers - This decrease was dose- and time-dependent CDR‒SB and MMSE data suggest a clinical benefit in patients continuing aducanumab over 24 months No new ARIA-E c
Slide 18: Acknowledgements
Interim analysis presented at CTAD 2016 Acknowledgements We thank all the patients and their family members participating in the aducanumab studies and the investigators and their staff conducting these studies.