Vtv Therapeutics Inc. · NASDAQ:VTVT
Vtv Therapeutics — Investor Presentation (November 2015)
29 slides from Vtv Therapeutics's investor presentation, Nov 17, 2015
Slide 1: Treatments for the Advancement of Life Investor Presentation
TREATMENTS FOR THE ADVANCEMENT OF LIFE INVESTOR PRESENTATION Exhibit 99.1
Slide 2: Disclaimer
Disclaimer The statements made in this presentation may include forward-looking statements regarding the Alzheimer’s disease and diabetes market, the future operations, opportunities or financial performance of vTv Therapeutics Inc. Although we believe that the expectations contained in this present
Slide 3: vTv Highlights - Addressing Huge Needs in Huge Markets
vTv Highlights- Addressing Huge Needs in Huge Markets Phase 2b data showed robust, long-lasting effect on cognitive and functional decline 3+ points on ADAS-Cog Potential benefits on CDR-SB, secondary endpoints (ADCS-ADL, MMSE, NPI) Two oral, small molecule candidates in Phase 2 studies First-in-cla
Slide 4: Late-Stage Pipeline
PROGRAM PRECLINICAL PHASE 1 PHASE 2 PHASE 3 STATUS EXPECTED TOPLINE DATA MILESTONES Alzheimer’s Disease Azeliragon (TTP488): RAGE Antagonist Phase 3 enrolling Late 2017/Early 2018 (Sub-study A) Mid 2018 (Sub-study B) Type 2 Diabetes TTP399: Glucokinase Activator Phase 2b enrolling Mid 2016 TTP273: O
Slide 5: Azeliragon: Late-Stage Alzheimer's Disease Candidate
Azeliragon: Late-Stage Alzheimer’s Disease Candidate Successful 2b study showed robust, long-acting effect on cognitive and functional decline; trumps other drugs in development Met primary endpoint: +3.1 points on ADAS-Cog in mild-to-moderate population Greater efficacy in mild patients, +4.0 point
Slide 6: TTP399: First-in-Class Glucokinase Activator
TTP399: First-in-Class Glucokinase Activator TTP399: Potential to transform oral diabetes market Novel mechanism of action: TTP399 is a liver-selective Glucokinase Activator (GKA) that offers a new paradigm for the treatment of type 2 and type 1 diabetes TTP399 demonstrated safety and efficacy clini
Slide 7: TTP273: Best-in-Class Small Molecule GLP-1r Agonist
TTP273: Best-in-Class Small Molecule GLP-1r Agonist Small molecule GLP-1r agonist Non-peptide, orally bioavailable TTP273 demonstrated safety and efficacy in clinical and preclinical studies Expected competitive edge vs. current GLP1 analogues : Superior tolerability Low incidence of GI AEs No antib
Slide 8: Alzheimer's Disease Program: Azeliragon
ALZHEIMER’S DISEASE PROGRAM AZELIRAGON Targeting RAGE (Antagonist of the Receptor for Advanced Glycation Endproducts)
Slide 9: RAGE Inhibition: A Multifactorial Target
RAGE Inhibition: A Multifactorial Target vTv owns exclusive rights to RAGE antagonists in AD until 2020 Azeliragon IP until 2029 Select RAGE Ligands: • Advanced Glycation Endproducts (AGEs) • HMGB1 • Aβ • S100 Proteins Azeliragon inhibits RAGE SIGNAL OFF SIGNAL ON • Aβ Production (β, γ secretase) •
Slide 10: Strong Clinical and Preclinical Rationale for RAGE in AD
Evidence in Human Studies Evidence in Animal Studies Strong Clinical and Preclinical Rationale for RAGE in AD RAGE protein is increased in autopsied AD brains compared to non-demented controls.(1) Increases in RAGE protein and percentage of RAGE-expressing microglia parallel disease severity. (1) RA
Slide 11: Preclinical Evidence for Azeliragon MOA
Preclinical Evidence for Azeliragon MOA Azeliragon Vehicle Reduction in Amyloid Load Increase in Glucose Uptake Hippocampus Frontal Cortex % FDG Vs Wildtype Reduce Inflammation Blocking of RAGE by Azeliragon in Mouse Models of Alzheimer’s Disease Prevention of the Deterioration of Cognitive Function
Slide 12: Azeliragon Phase 2b Study Results
Azeliragon Phase 2b Study Results Key Outcomes: 5mg/day dose met primary endpoint (ADAS-Cog11) at 18 months in mild-to-moderate disease (+3.1 pts.) Greater effect on mild disease (+4.0 pts.) Significant reduction in psychiatric events Favorable trends in all other secondary endpoints 5mg/day safe an
Slide 13: Azeliragon Phase 2b Met Pre-Specified Primary Endpoint ADAS-Cog
Azeliragon Phase 2b Met Pre-Specified Primary Endpoint ADAS-Cog
Slide 14: Azeliragon Phase 2b: Secondary Efficacy Endpoints at Month 8
Azeliragon Phase 2b: Secondary Efficacy Endpoints at Month 18 FAVORABLE TRENDS IN SECONDARY ENDPOINTS EVEN THOUGH THE STUDY WAS NOT POWERED TO SHOW SECONDARY EFFICACY
Slide 15: Azeliragon: Significant Reduction of Psychiatric Events
Azeliragon: Significant Reduction of Psychiatric Events SAFE AND WELL-TOLERATED WITH A STATISTICALLY SIGNIFICANT REDUCTION OF PSYCHIATRIC ADVERSE EVENTS (AEs) Overall Incidence Psychiatric AEs Incidence Of Specific Psychiatric AEs p=0.037 p=0.017
Slide 16: Azeliragon: Unprecedented Efficacy in Alzheimer's Disease Drug Candidate
Azeliragon: Unprecedented Efficacy in Alzheimer’s Disease Drug Candidate Azeliragon Phase 2b TTP488-203 (n=202) Mild Azeliragon Phase 2b TTP488-203 (n=399) Mild-Mod RVT-101 Phase 2b 0866Study1 (n= 684) Solanezumab Phase 3 EXPEDITION 12 (n= 1,012) Solanezumab Phase3 EXPEDITION 22 (n = 1,040) ADAS-Cog
Slide 17: STEADFAST Study
STEADFAST STUDY Ongoing Phase 3 Clinical Trial Under SPA Randomized, double-blind, parallel group, 18-month trial in 800 patients with mild AD 80 sites initiated and enrolling; targeting approximately 100 sites in U.S. and Canada Two independently powered sub-studies (sub-study A and sub-study B) un
Slide 18: Type 2 Diabetes Programs
TYPE 2 DIABETES PROGRAMS GLUCOKINASE ACTIVATOR (TTP399) GLP-1r AGONIST (TTP273)
Slide 19: TTP399: First-in-Class Glucokinase Activator (GKA)
TTP399: First-in-Class Glucokinase Activator (GKA) Does not activate GK in the pancreas Does not interrupt the interaction of GK with the GK Regulatory Protein (GKRP) GK human mutations are a genetic validation of GK as a target for the treatment of diabetes TTP399 Is A Novel Liver Selective GKA Tha
Slide 20: TTP399 Mechanism of Action
TTP399 Mechanism of Action Imbalance between glucose production (↑) and glucose utilization (↓) is a hallmark of diabetes Glucose production Glucose utilization HYPERGLYCEMIA Balance GK activation in the liver restores the balance between glucose production and glucose utilization NORMOGLYCEMIA Gluc
Slide 21: TTP399: Significantly Improved HbA1c After Only Weeks
TTP399: Significantly Improved HbA1c After Only 6 Weeks “Well Controlled” Subjects Mean A1C at baseline ≤ 7.5% All Subjects Mean A1C at Baseline 8.2% No hypoglycemia or increase in lipids were observed during the study Even subjects “well controlled” on Metformin (HbA1c<7.5% at day1) reached target
Slide 22: TTP399 vs. Oral Diabetic Treatments
TTP399 vs. Oral Diabetic Treatments Effects Observed in Patients TTP 399 DPPIV SLGT2 Efficacy Lowers blood glucose Lowers HbA1c >1% X X Normalizes HbA1c (<6.5%) X X Weight loss ? X Effective at all stages of Type 2 Diabetes X Safety No risk of ketoacidosis X No risk of genitourinary infections X No
Slide 23: Currently Enrolling Phase 2b Study
Currently Enrolling Phase 2b Study Topline Results Expected Mid 2016 A 6 month, randomized, double-blind, placebo- and active-controlled, parallel group trial in 180 type 2 diabetics on stable doses of metformin 21 sites in the United States; Principal Investigator Dr. Adrian Vella (Mayo Clinic) 7.5
Slide 24: TTP273: Designed to Supplant Blockbuster GLP-1 Analogues
TTP273: Designed to Supplant Blockbuster GLP-1 Analogues Best-in-class, Oral, Small Molecule Glp-1r Agonist Demonstrated Efficacy With Superior Tolerability Than The Peptide GLP-1 Analogues No GI side effects Phase 2 (LOGRA) Study Scheduled To Start 1Q 2016 Data readout expected late 2016 Non-peptid
Slide 25: TTP273 Clinical Results
TTP273 Clinical Results Completed 112 patient Phase 1b trial in type 2 diabetes All doses were safe and well tolerated with no serious AEs No evidence of GI side effects TTP273 demonstrated robust effects on postprandial & fasting glucose Groups defined by daily dose: PBO, Low dose (<150mg) or High
Slide 26: TTP273 vs. Best Seller GLP-1 Analogues
TTP273 vs. Best Seller GLP-1 Analogues Effects Observed in Patients TTP273 GLP-1r Agonist Victoza®* Safety No significant gastrointestinal side effects X Convenience Oral X Ideal for co-formulation with existing OADs X No need for medical device X Efficacy Lowers blood glucose Decreases HbA1c levels
Slide 27: TTP273: LOGRA Phase 2 Study
TTP273: LOGRA Phase 2 Study Topline Results Expected Late 2016 Randomized, double-blind, placebo-controlled, parallel group trial in 156 type 2 diabetics on stable doses of metformin Targeting 26 sites in the United States 7.5-10 % baseline HbA1c Arms: Placebo TTP273 150mg once daily TTP273 150mg tw
Slide 28: Treatments for the Advancement of Life
TREATMENTS FOR THE ADVANCEMENT OF LIFE
Slide 29: vTv Highlights - Addressing Huge Needs in Huge Markets
vTv Highlights- Addressing Huge Needs in Huge Markets Phase 2b data showed robust, long-lasting effect on cognitive and functional decline 3+ points on ADAS-Cog Potential benefits on CDR-SB, secondary endpoints (ADCS-ADL, MMSE, NPI) Two oral, small molecule candidates in Phase 2 studies First-in-cla
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