Cocrystal Pharma, Inc. · NASDAQ:COCP
Cocrystal Pharma — 7th ISIRV-AVG Conference 2023
18 slides from Cocrystal Pharma's conference presentation, May 4, 2023
Slide 1: First-in-Human Study of CC-42344, A Novel Broad-Spectrum Influenza A Polymerase PB2 Inhibitor
First-in-Human Study of CC-42344, A Novel Broad-Spectrum Influenza A Polymerase PB2 Inhibitor Sam Lee, Ph.D. President & Co-CEO 7th ISIRV-AVG CONFERENCE May 4 , 2023
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the market opportunities for the treatment of acute and chronic viral diseases which are the focus of our progra
Slide 3: Influenza A Is Responsible For Pandemic and Seasonal infections
Influenza A Is Responsible For Pandemic and Seasonal infections The influenza pandemic 100 years: >53 million deaths Taubenberger JK et al. Sci. Transl. Med. 2019; 11, eaau5485 3 3
Slide 4: PB2 is an Attractive Drug Target for Pandemic and Seasonal Influenza
PB2 is an Attractive Drug Target for Pandemic and Seasonal Influenza Avian Influenza PB2 Acquires Mutations Before Human Pandemic Influenza PB2 protein ▪ Essential for viral replication ▪ Human adaptation PB2 mutations including 1918 Spain E627K increase ↑ Polymerase activity ↑ Viral replication ↑Pa
Slide 5: Cocrystal's PB2 Inhibitor CC-42344 Blocks The First Step of Influenza A Viral Replication
Cocrystal’s PB2 Inhibitor CC-42344 Blocks The First Step of Influenza A Viral Replication Baloxavir T-705 PB2 inhibitor CC-42344 Boivin S et al. J. Biol. Chem. 2010;285:28411-28417 5 5 5
Slide 6: CC-42344 is a Broad-Spectrum Antiviral with High Barrier to Resistance
CC-42344 is a Broad-Spectrum Antiviral with High Barrier to Resistance: Targeting a Highly Conserved Active Site of PB2 Structure-based drug discovery platform technology was applied for CC-42344 development (A) PB2:ssRNA complex (B) Highly conserved binding pocket (C) PB2:CC-42344 structure H432 ss
Slide 7: CC-42344 vs Pimodivir (VX-787): Key Differences
CC-42344 vs Pimodivir (VX-787): Key Differences Property Pimodivir (VX-787) Cocrystal CC-42344 Broad-spectrum activity Single digit nanomolar EC50 Single digit nanomolar EC50 Seasonal and pandemic influenza A strains Seasonal and pandemic influenza A strains Six major resistance variants on PB2 No r
Slide 8: CC-42344 Shows Highly Favorable Safety and Excellent Antiviral Activity in H1N1-Infected Human Bronchial Epithelia
CC-42344 Shows Highly Favorable Safety and Excellent Antiviral Activity in H1N1-Infected Human Bronchial Epithelia H1N1 + No CC-42344 No treatment Normal human respiratory epithelia + H1N1 infection H1N1-infected bronchial epithelia H1N1 + CC-42344 With CC-42344 8
Slide 9: A Phase 1 Study in Healthy Participants to Evaluate the Safety, Tolerability, and PK
A Phase 1 Study in Healthy Participants to Evaluate the Safety, Tolerability, and PK of the Oral Influenza A PB2 Inhibitor CC-42344 9 Clinical Trial Registration: 9 NCT05202379
Slide 10: Phase 1 Study Complete
Phase 1 Study Complete Phase 1 trial site: Linear Clinical Research-Harry Perkins Research Institute, Perth, Australia Participants: ▪ Single-center, randomized, double-blind, placebo-controlled ▪ Single-ascending dose, multiple-ascending dose; 7-day nontreatment follow-up period ▪ Healthy adult vol
Slide 11: Key Entry Criteria
Key Entry Criteria ▪ Healthy males and females ≥ 18 and ≤ 55 years ▪ Body weight ≥ 50 kg ▪ Body mass index ≥ 18 and ≤ 32 kg/m2 ▪ Non-pregnant, non-lactating ▪ Must abstain from alcohol or caffeine from 48 hours before study confinement through study ▪ Must not have taken prescribed medication in 14
Slide 12: Demographics of SAD and MAD cohorts
Demographics of SAD and MAD cohorts SAD MAD (N=32) (N=24) Age (Years) 33.0 ± 11.1 25.8 ± 5.7 Mean 30.0 24.0 Median 18-54 19-39 Range Male, n (%) 18 (56%) 18 (75%) Ethnicity, n (%) Hispanic or Latino 5 (16%) 2 (8%) Not Hispanic or Latino 27 (84%) 22 (92%) Race, n (%) American Indian or Alaska Native
Slide 13: SAD: Summary of Treatment-Emergent Adverse Events
SAD: Summary of Treatment-Emergent Adverse Events CC-42344 Placebo All System Organ Class (SOC) Fasted Fasted Subjects Preferred Term (PT) (N=24) (N=8) (N=32) n (%) E n (%) E n (%) E Subjects with at Least One TEAE 10 (42%) 14 4 (50%) 6 17 (53%) 23 Nervous system disorders, n (%) 5 (21%) 5 4 (50%) 4
Slide 14: MAD: Summary of Treatment-Emergent Adverse Events
MAD: Summary of Treatment-Emergent Adverse Events CC-42344 Placebo All System Organ Class (SOC) Fed Fed Subjects Preferred Term (PT) (N=18) (N=6) (N=24) n (%) E n (%) E n (%) E Subjects with at Least One TEAE 12 (67%) 27 4 (67%) 11 16 (67%) 38 Injury, poisoning and procedural complications 5 (28%) 7
Slide 15: Topline Safety Data Summary
Topline Safety Data Summary SAD cohorts MAD cohorts Overall treatment-emergent AE (TEAE) rate Overall treatment-emergent (TEAE) rate ▪ 42% (10/24) in CC-42344 cohorts ▪ 67% (12/18) in CC-42344 cohorts ▪ 50% (4/8) in placebo subjects ▪ 67% (4/6) in placebo subjects Headache was the most frequently re
Slide 16: Phase 1 SAD and MAD summary and next steps
CC-42344 Oral PB2 Inhibitor Shows a Highly Favorable Safety and Tolerability Profile with Oral administration to healthy volunteers Phase 1 SAD and MAD summary and next steps ▪ Phase 1 study healthy volunteer study completed: ➢ No serious or grade 3 AEs reported ➢ No treatment discontinuations ➢ No
Slide 17: CC-42344: Potential to Be Best-in-Class Influenza A PB2 Inhibitor
CC-42344: Potential to Be Best-in-Class Influenza A PB2 Inhibitor 🗸 Activity against pandemic and seasonal Broad-spectrum activity influenza A strains and drug resistant strains 🗸 Single digit nanomolar potency with high Potency and resistance barrier to resistance 🗸 Mechanism of Action Novel…
Slide 18: Influenza A Oral Inhibitor CC-42344
Influenza A Oral Inhibitor CC-42344 Nasdaq: COCP www.cocrystalpharma.com