Slide 1: Crenezumab Phase I Study
Crenezumab Phase I Study © 2016 AC Immune. Not to be used or reproduced without permission.
Slide 2: Crenezumab Background
© 2016 AC Immune. Not to be used or reproduced without permission. 2 Crenezumab Background Crenezumab (RO5490245) is a humanized anti - amyloid β monoclonal IgG4 antibody ▪ Binds multiple forms of amyloïdes β ( monomers , oligomers , fibrils , plaques) with high affinity for oligomers ▪ IgG4 hypothe
Slide 3: Crenezumab Phase Ib Study GN29632
© 2016 AC Immune. Not to be used or reproduced without permission. 3 Crenezumab Phase Ib S tudy GN29632 Phase Ib GN29632 ▪ Crenezumab 30, 45, 60 and 120 mg/kg IV Q4 weeks vs placebo Study population ▪ MMSE 18 - 28 ▪ 50 - 90 years ▪ Probable mild to moderate AD by NINCDS - ADRDA criteria ▪ CDR global
Slide 4: Crenezumab Phase Ib Study GN29632
© 2016 AC Immune. Not to be used or reproduced without permission. 4 Crenezumab Phase Ib S tudy GN29632 Phase Ib GN29632 ▪ Crenezumab 30, 45, 60 and 120 mg/kg IV Q4 weeks vs placebo Study population ▪ MMSE 18 - 28 ▪ 50 - 90 years ▪ Probable mild to moderate AD by NINCDS - ADRDA criteria ▪ CDR global
Slide 5: Assessments
© 2016 AC Immune. Not to be used or reproduced without permission. 5 Crenezumab Phase Ib S tudy A ssessments ▪ Safety • Brain MRI (central read ) • Nature, frequency , severity of adverse events (Aes) and serious AEs • Examinations : Physical and neurologic , vital signs • Laboratory tests ( blood a
Slide 6: Phase Ib Safety Results: Patient baseline characteristics and treatment exposure
© 2016 AC Immune. Not to be used or reproduced without permission. 6 Crenezumab Characteristics ▪ Age, mean (range) ▪ Male, n (%) ▪ ApoE status, n (%) E2/E3 E3/E3 E3/E4 E4/E4 ▪ Baseline MMSE, mean (range) ▪ Medium duration of exposure Cohort 1 (n=26) 73.5 (54 - 82) 14 (54%) 1 (2%) 5 (19%) 17 (65%) 3
Slide 7: Phase Ib Safety Results: Cohort I (30 & 45 mg/kg)
© 2016 AC Immune. Not to be used or reproduced without permission. 7 Crenezumab Adverse event (AE) summary, n (%) ▪ Total number of patients with at least one AE ▪ AE related to study treatment (as assessed by investigator) ▪ AE Grade ≥ 3 (severe, life - threatening or resulting in death) 1 ▪ Seriou
Slide 8: Phase Ib Safety Results: Cohort II (60 mg/kg)
© 2016 AC Immune. Not to be used or reproduced without permission. 8 Crenezumab Adverse event (AE) summary, n (%) ▪ Total number of patients with at least one AE ▪ AE related to study treatment (as assessed by investigator) ▪ AE Grade ≥ 3 (severe, life - threatening or resulting in death) ▪ Serious
Slide 9: Crenezumab Phase Ib Serum Pharmacokinetics
© 2016 AC Immune. Not to be used or reproduced without permission. 9 Crenezumab Phase Ib Serum Pharmacokinetics ▪ Serum PK of crenezumab exhibits biphasic disposition with a long half - life (approx. 25 days) - Consistent with other LgG antibodies that exhibit linear kinetics 2 ▪ Steady - state conc
Slide 10: Conclusions: Analysis of Cohort I and II
© 2016 AC Immune. Not to be used or reproduced without permission. 10 Crenezumab Phase Ib S tudy C onclusions: A nalysis of Cohort I and II ▪ Safety of crenezumab for doses of 30, 45 and 60 mg/kg • Majority of Aes were low - grade and non - serious • No dose - limiting toxicities • No investigator -