Assembly Biosciences, Inc. · NASDAQ:ASMB
Assembly Biosciences — AASLD 2019 Review
21 slides from Assembly Biosciences's conference presentation, Nov 12, 2019
Slide 1: AASLD 2019 Review
AASLD 2019 Review November 11, 2019 Exhibit 99.1
Slide 2: Agenda and Speakers on Today's Call
Agenda and Speakers on Today’s Call Agenda Introductions and Safe Harbor Overview of ASMB vision and HBV core inhibitor portfolio Review of HBV data from AASLD ABI-H0731 Final 24 week data from Study 201 and 202 Interim long-term data from Study 211 ABI-H2158 Interim data from initial dosing cohort
Slide 3: Cautionary Note Regarding Forward-Looking Statements
Cautionary Note Regarding Forward-Looking Statements The information in this presentation contains forward-looking statements regarding future events, including statements about the clinical and therapeutic potential of Assembly Biosciences’ HBV-cure program, the therapeutic potential of core inhibi
Slide 4: Our Vision for Achieving HBV Curative Finite Regimens
Our Vision for Achieving HBV Curative Finite Regimens HBV can and will be cured Over time, cure rates will increase and Tx duration shorten Core inhibitors will be central to curative strategies Block multiple steps in the HBV life cycle Cure rates will increase as the field advances Tx will be fini
Slide 5: Assembly's Planned Approach to Hepatitis B Clinical Development
Assembly’s Planned Approach to Hepatitis B Clinical Development 1st generation CI Candidate Designed to achieve complete suppression of viral replication (HBV DNA and RNA) Two potential paths to registration that are complementary: Chronic suppressive therapy Finite Duration Consolidation period of
Slide 6: Program Objectives - Targeted Steps Toward Cure
Program Objectives - Targeted Steps Toward Cure Well-tolerated, PK supporting once daily dosing, and inhibits HBV DNA with monotherapy (Phase 1) Demonstrated elimination of residual viral replication not achievable on NrtI monotherapy (i.e DNA to “Target not Detected”) (Phase 2) Demonstrated decreas
Slide 7: Overview of ABI-H0731 Phase 2a Clinical Studies
Overview of ABI-H0731 Phase 2a Clinical Studies *n values represent the 87 patients who transitioned to 211 and remain on treatment and included in this analysis ETV, entecavir, Pbo, placebo, SOC, standard of care
Slide 8: Demographics and Baseline Characteristics
Demographics and Baseline Characteristics LLOQ, lower limit of quantification; aGenotypes in Study 201 were determined by sequence alignment; genotypes in Study 202 were determined by InnoLipa HBV at a central lab; bAs measured by Roche Cobas qPCR, LLOQ = 20 IU/mL; Reported mean (range) for Study 20
Slide 9: 202: Superior DNA/pgRNA Declines Observed with 731+ETV Combination
Study 202: Superior DNA/pgRNA Declines Observed with 731+ETV Combination Faster HBV DNA declines were observed with 731+ETV than with ETV alone, with statistically significant declines in HBV DNA observed in the combo arm at Week 24 (p=0.0452) Rapid 2-log reductions in HBV pgRNA levels by Week 2 wer
Slide 10: 201: DNA/pgRNA Declines Observed in NrtI-Suppressed, HBeAg+ Patients
Study 201: DNA/pgRNA Declines Observed in NrtI-Suppressed, HBeAg+ Patients Among HBeAg-positive patients, rapid reductions in HBV pgRNA levels by Week 8 were observed only in patients treated with 731+ETV Significant pgRNA Declines on Combination 22 of 27 (81%) 731+NrtI treated patients achieved TND
Slide 11: 202/211: Further DNA/pgRNA Declines Observed over Time
Study 202/211: Further DNA/pgRNA Declines Observed over Time HBV DNA levels HBV pgRNA levels Switch from ETV to 731+ETV resulted in immediate and enhanced declines in both HBV DNA and pgRNA levels The mean HBV DNA and pgRNA declines from baseline at Week 48 were 6.3 logs and 3.0 logs, respectively,
Slide 12: 201/211: DNA/pgRNA Declines to Highly Suppressed Levels
Study 201/211: DNA/pgRNA Declines to Highly Suppressed Levels Observed in NrtI-Suppressed Patients Only patients receiving 731+ETV had reduced HBV DNA levels to TND and pgRNA levels to <35 U/mL HBV DNA “Target Not Detected” (<5 IU/mL) HBV pgRNA “<35 U/mL” (LLOQ 35 U/mL)
Slide 13: 202/211: Correlation Between HBV pgRNA Reductions and Viral Antigen Declines
Study 202/211: Correlation Between HBV pgRNA Reductions and Viral Antigen Declines in the Absence of ALT Elevations Addition of 731 resulted in multi-log reductions in pgRNA; NrtI therapy failed to significantly reduce pgRNA Second phase decline of pgRNA appears to reflect decline in cccDNA pools: >
Slide 14: 201/211: Progression of Viral Markers in HBV NrtI-Suppressed Patients
Study 201/211: Progression of Viral Markers in HBV NrtI-Suppressed Patients Viral markers in these patients receiving long-term NrtI treatment were significantly lower than in Rx-naïve patients, with several approaching the LLOQ Results are supportive of mixed source (cccDNA and integrants) HBsAg in
Slide 15: 201/202: Final Safety Data
Study 201/202: Final Safety Data Summary 731 was well-tolerated when administered with a NrtI for 24 weeks Overall, 26/58 subjects reported no AEs. Of the 32 subjects reporting ≥1 AE, 23 had Grade 1, and 9 had Grade 2 events. No serious AEs were reported With longer-term treatment in Study 211, the
Slide 16: 201/202: Laboratory Abnormalities
Study 201/202: Laboratory Abnormalities Overall, laboratory abnormalities observed were of Grade 1 or 2 severity and occurred in similar proportions of patients across the two treatment groups With longer-term treatment in Study 211, the profile of laboratory abnormalities observed are similar to th
Slide 17: ABI-H0731 Core Inhibitor Program Summary
ABI-H0731 Core Inhibitor Program Summary Summary of Interim Data for Phase 2a Studies with ABI-H0731 Well tolerated Combination of 731+NrtI demonstrated superior antiviral activity vs. NrtI monotherapy Faster and deeper declines in HBV DNA observed HBV DNA TND and pgRNA <35 U/mL thresholds only achi
Slide 18: 2158: Interim Phase 1b Antiviral Activity Data
2158: Interim Phase 1b Antiviral Activity Data HBV DNA Change from Baseline, Cohort 1 (100mg QD) HBV pgRNA Change from Baseline, Cohort 1 (100mg QD) In patients receiving ABI-H2158, mean declines from Baseline to Day 15 in HBV DNA and pgRNA levels were 2.3 log10 IU/mL (range 1.7–3.0) and 2.1 log10 I
Slide 19: 2158: Interim Phase 1b Pharmacokinetics Data
2158: Interim Phase 1b Pharmacokinetics Data Pharmacokinetics at Day 14, Cohort 1 100mg Steady-state exposures observed at the lowest dose level of 100 mg QD are in excess of the EC90 values for in vitro antiviral and cccDNA assays We believe that these data support once daily oral administration
Slide 20: Program Objectives - Targeted Steps Toward Cure
Program Objectives - Targeted Steps Toward Cure Well-tolerated, PK supporting once daily dosing, and inhibits HBV DNA with monotherapy (Phase 1) Demonstrated elimination of residual viral replication not achievable on NrtI monotherapy (i.e DNA to “Target not Detected”) (Phase 2) Demonstrated decreas
Slide 21: Thank you
O assemblybio Thank you