Indivior Pharmaceuticals, Inc. · NASDAQ:INDV
Indivior Pharmaceuticals — Technical Presentation (June 2017)
29 slides from Indivior Pharmaceuticals's technical presentation, Jun 29, 2017
Slide 1: RBP-6000 Buprenorphine Monthly Depot Phase III Clinical Results
RBP-6000 BUPRENORPHINE MONTHLY DEPOT PHASE III CLINICAL RESULTS RBP-6000 INVESTOR EVENT JUNE 29TH, 2017 Our vision is that all patients around the world will have access to quality treatment for the chronic relapsing conditions and co-morbidities of addiction
Slide 2: Notice
NOTICE This presentation contains certain statements that are forward-looking and which should be considered, amongst other statutory provisions, in light of the safe harbour provisions of the United States Private Securities Litigation Reform Act of 1995. By their nature, forward-looking statements
Slide 3: Today's Agenda
TODAY’S AGENDA OPENING STATEMENTS SHAUN THAXTER, CHIEF EXECUTIVE OFFICER Our vision is that all patients around the world will have INTRODUCTION access to quality treatment for the chronic relapsing conditions CHRISTIAN HEIDBREDER, CHIEF SCIENTIFIC OFFICER and co-morbidities of addiction RBP-6000 PH
Slide 4: Opening Statements
OPENING STATEMENTS SHAUN THAXTER, CHIEF EXECUTIVE OFFICER Our vision is that all patients around the world will have access to quality treatment for the chronic relapsing conditions and co-morbidities of addiction
Slide 5: Our Vision
OUR VISION For all patients around the world to have access to quality treatment for the chronic relapsing conditions and co-morbidities of addiction
Slide 6: Introduction
INTRODUCTION CHRISTIAN HEIDBREDER, CHIEF SCIENTIFIC OFFICER Our vision is that all patients around the world will have access to quality treatment for the chronic relapsing conditions and co-morbidities of addiction
Slide 7: RBP-6000 Development Milestones
RBP-6000 DEVELOPMENT MILESTONES Pre-IND submission: December 18th, 2009 First-in-Man study (20 mg) Pre-IND meeting with FDA: April 27th, 2010 Single Ascending Dose (SAD) study IND submission: September 17th, 2010 (50, 100, 200 mg) Type C meeting: May 14th, 2013 Multiple Ascending Dose
Slide 8: Summary
SUMMARY Both dosage regimens of RBP-6000 show statistically significant differences in percentage abstinence and treatment success vs. placebo. Treatment outcomes are consistent across other clinical endpoints including control of craving and withdrawal symptoms. Results from the exposure-resp
Slide 9: Brain μ-Opioid Receptors Are Relevant to Treating OUD
Brain μ-OPIOID RECEPTORS (μOR) ARE RELEVANT TO TREATING OUD [11C]Carfentanil PET has been successfully used to MRI reliably measure in vivo brain μOR availability following buprenorphine administration in opioid- Bup 0 dependent patients. At least 70% brain μ-opioid receptor (μOR) Bup 2 occupanc
Slide 10: Pharmacodynamic Action of Buprenorphine Decreases with Plasma Concentrations and μOR Occupancy
PHARMACODYNAMIC ACTION OF BUPRENORPHINE DECREASES WITH A DECREASE IN PLASMA CONCENTRATIONS & BRAIN μOR OCCUPANCY Acute sublingual (SL) buprenorphine duration of pharmacodynamic action (estimated by abstinence, suppression of withdrawal and craving, and blockade 18% of the effects of an opioid agon
Slide 11: Plasma Concentration ≥2 ng/mL Is Minimum Threshold for Blockade of Drug Liking
BUPRENORPHINE PLASMA CONCENTRATION ≥ 2NG/ML (≥ 70% μOR OCCUPANCY) IS THE MINIMUM THRESHOLD TO ACHIEVE BLOCKADE OF DRUG LIKING RBP-6000 300mg vs. RBP-6000 300mg vs. Hydromorphone 18mg Hydromorphone 6mg Plot of mean difference and 95% confidence interval for “Drug Liking” VAS score. Comparison of plac
Slide 12: Phase III Clinical Efficacy & Safety Trial
PHASE III CLINICAL EFFICACY & SAFETY TRIAL SUSAN LEARNED, SENIOR VP GLOBAL CLINICAL DEVELOPMENT Our vision is that all patients around the world will have access to quality treatment for the chronic relapsing conditions and co-morbidities of addiction
Slide 13: Phase III Efficacy & Safety Study (RB-US-13-0001)
PHASE III EFFICACY & SAFETY STUDY (RB-US-13-0001) A Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Title Tolerability of Multiple Subcutaneous Injections of RBP-6000 [100 mg and 300 mg] Over 24 Weeks in Treatment-Seeking Subjects with Opioid Use D
Slide 14: RBP-6000: Phase III Study Design
RBP-6000: PHASE III STUDY (RB-US-13-0001) DESIGN Treatment Period: • 6 double-blind subcutaneous injections • Weekly urine drug screens and self-reports • Weekly individualized counseling (IDC) Follow Up (option to roll into Randomization RBP-6000 300 mg x 2 months/ safety extension) (n= 504) 100 mg
Slide 15: RBP-6000 Clinical Efficacy
RBP-6000 CLINICAL EFFICACY Our vision is that all patients around the world will have access to quality treatment for the chronic relapsing conditions and co-morbidities of addiction
Slide 16: RBP-6000: Primary & Secondary Endpoints
RBP-6000: PRIMARY & SECONDARY ENDPOINTS Primary: CDF of % urine samples negative Key secondary: ≥80% of urine samples for opioids + negative self-reports of illicit negative for opioids + negative self-reports opioid use (Weeks 5 to 24) of illicit opioid use (Weeks 5 to 24) 100 RBP-6000 300/100 mg +
Slide 17: Primary/Secondary Endpoints & Exposure-Response
RBP-6000: PRIMARY/SECONDARY ENDPOINTS & EXPOSURE-RESPONSE RBP-6000 RBP-6000 Placebo 300mg/100mg 300mg/300mg Percentage Abstinent Weeks Mean (SD) 42.7% (38.50%) 41.3% (39.66%) 5.0% (16.98%) p-value < 0.0001 < 0.0001 - ≥ 80% Abstinent Weeks (Responder) Treatment Success* 28.4% 29.1% 2.0% p-value < 0.0
Slide 18: Clinical Opiate Withdrawal Scale + Craving VAS
CLINICAL OPIATE WITHDRAWAL SCALE (COWS) + CRAVING VAS Mean COWS (LOCF) Mean Opiate Craving VAS (LOCF) 4.0 Clinical Opiate Withdrawal Scale 25 Opiate Craving VAS (mm) 3.5 (COWS) Mean Score 20 Mean Score 3.0 2.5 15 2.0 10 1.5 1.0 5 0 2 4 6 8 10 12 14 16 18 20 22 24 0 2 4 6 8 10 12 14 16 18 20 22 24 Ba
Slide 19: RBP-6000: Secondary Endpoints Summary
RBP-6000: SECONDARY ENDPOINTS SUMMARY RBP-6000 (300mg/100mg + IDC) vs. RBP-6000 (300mg/300mg + IDC) vs. placebo + IDC (N=194) placebo + IDC (N=196) Secondary Efficacy Endpoints Opioid Craving Visual Analog Scale Scores (VAS) Difference in LS means (SE) -9.4 (2.62) -12.4 (2.61) 95% CI -14.56, -4.30 -
Slide 20: 2ng/mL Threshold & Withdrawal Reduction
RBP-6000: 2NG/ML THRESHOLD & WITHDRAWAL REDUCTION 2 ng/mL SOWS 2 ng/mL COWS RBP-6000 Investor Event June 29th, 2017 - Proprietary to INDIVIOR - RBP-6000 is an investigational product that has not been approved by the U.S. FDA or any other health authority 20
Slide 21: 2ng/mL Threshold & Craving Reduction
RBP-6000: 2NG/ML THRESHOLD & CRAVING REDUCTION Craving ≤ 20 Craving ≤ 5 Craving = 0 2 ng/mL RBP-6000 Investor Event June 29th, 2017 - Proprietary to INDIVIOR - RBP-6000 is an investigational product that has not been approved by the U.S. FDA or any other health authority 21
Slide 22: Association Between Plasma Concentrations, Predicted μOR Occupancy & Clinical Endpoints
ASSOCIATION BETWEEN PLASMA CONCENTRATIONS OF BUPRENORPHINE, PREDICTED μOR OCCUPANCY & CLINICAL ENDPOINTS 5.0 4.3 4.0 EC50 (ng/mL) 3.0 2.0 1.2 1.0 0.0 By Non-injectable By Injectable Route Route Dose Group N Cmin (ng/mL) Cmax (ng/mL) Cavg (ng/mL) μORO (%)* Abstinence Rate (Day 169) in Users by Inject
Slide 23: RBP-6000 Clinical Safety
RBP-6000 CLINICAL SAFETY Our vision is that all patients around the world will have access to quality treatment for the chronic relapsing conditions and co-morbidities of addiction
Slide 24: RBP-6000: Safety Profile Phase III
RBP-6000: SAFETY PROFILE PHASE III EFFICACY & SAFETY 90 80 76.4 70 66.7 60 56.0 % Occurrence 50 40 33 34.8 30 23.0 20 10 7.4 6.5 5.0 4 3.4 5.0 2.0 3.5 0 0 0 2 0 Any TEAE Related TEAEs Serious TEAEs Related Serious Severe TEAEs TEAEs leading to TEAEs discontinuation RBP-6000 (300mg/100mg) % RBP-6000
Slide 25: RBP-6000: Safety Profile, TEAEs ≥5%
RBP-6000: SAFETY PROFILE PHASE III EFFICACY & SAFETY Blood CPK increased 1 5.4 2.5 Headache 6 9.4 8.5 Nasopharyngitis 1 5.4 5 URT Infection 1 7.4 6 Vomiting 4 9.4 5.5 Constipation 0 9.4 8 Nausea 5 8.9 8 Fatigue 3 3.9 6 Injection site pain 3 4.9 6 Injection site pruritus 4 6.4 9.5 Placebo RBP-6000 (3
Slide 26: Conclusion
CONCLUSION CHRISTIAN HEIDBREDER, CHIEF SCIENTIFIC OFFICER Our vision is that all patients around the world will have access to quality treatment for the chronic relapsing conditions and co-morbidities of addiction
Slide 27: Summary
SUMMARY Both dosage regimens of RBP-6000 showed statistically significant differences in percentage abstinence and treatment success vs. placebo. Treatment outcomes were consistent across other clinical endpoints including control of craving and withdrawal symptoms. Results from the exposure-r
Slide 28: Post-CPDD Conferences 2017
POST-CPDD CONFERENCES 2017 Conference Where? When? What? American Conference on Fort Lauderdale, FL Oct 15th-18th Phase III PK/PD/RO model Pharmacometrics (ACoP) Canadian Society of Addiction Niagara Falls, ON Oct 19th-21st Phase III efficacy & safety results Medicine (CSAM) (Encore session) Associa
Slide 29: Thank You
THANK YOU Our vision is that all patients around the world will have access to quality treatment for the chronic relapsing conditions and co-morbidities of addiction