Avalo Therapeutics, Inc. · NASDAQ:AVTX
Avalo Therapeutics — Cerecor — Technical Presentation (January 2021)
15 slides from Avalo Therapeutics's technical presentation, Jan 5, 2021
Slide 1: CERC-002: Double-blind, Placebo-controlled Proof-of-concept Trial in COVID-19 ARDS
CERC-002: Double-blind, Placebo-controlled Proof-of-concept Trial in Patients with COVID-19 Mild to Moderate ARDS January 2021 Exhibit 99.2
Slide 2: Forward-Looking Statements
2| Forward-Looking Statements This presentation may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and
Slide 3: Successful Proof of Concept for CERC-002 in Patients Hospitalized with COVID-19 ARDS
3| Successful Proof of Concept for CERC-002 in Patients Hospitalized with COVID-19 ARDS Executive Summary • Proof of concept demonstrated in hospitalized patients with COVID-19 related ARDS – COVID-19 patients treated with a single dose of CERC-002 demonstrated robust improvement in the primary endp
Slide 4: LIGHT is a Central Driver of COVID-19 Related Cytokine Storm
4| LIGHT is a Central Driver of COVID-19 Related Cytokine Storm Clinical Trial Initiated After Compelling Biomarker Study Completed June 2020 P = 0.021 • In patients over 60, LIGHT levels were significantly higher in those that eventually died than in those patients that recovered (p=0.021) • Observ
Slide 5: CERC-002: A Novel First-in-Class Anti-LIGHT (TNFSF14) mAb
5| SQ: Subcutaneous; NOAEL: No observed adverse effect level The only known clinical stage anti-LIGHT antibody CERC-002: A Novel First-in-Class Anti-LIGHT (TNFSF14) mAb • In-licensed from Kyowa Kirin Co. • Positive toxicology profile – 8-week monkey toxicology study was well tolerated up to 100 mg/k
Slide 6: CERC-002 Treatment of Cytokine Storm-Induced COVID-19 ARDS: Trial Design
6| CERC-002 Treatment of Cytokine Storm-Induced COVID-19 ARDS Primary Endpoint: Respiratory Failure and Mortality Over 28 Days 1:1 Randomization CERC-002 (16 mg/kg [maximum 1200 mg]) on Day 1 by SQ injection + Standard of Care at the site Placebo-matched SQ injection + Standard of Care at the site R
Slide 7: Patient Disposition Chart
7| Patient Disposition Chart Screening: Patients with COVID-19 associated Pneumonia and Mild to Moderate ARDS 1:1 Randomization to SoC + CERC-002 or Placebo (n = 83) Patients free of High Flow O2 or Positive Pressure O2 (n = 62) All Patients administered CERC-002 or Placebo (n = 82) ITT Analysis for
Slide 8: Patient Demographics
8| Patient Demographics Characteristic CERC-002 (n=41) Placebo (n=42) Age Mean (SD) 59.2 (14.5) 58.1 (14.2) Age Group < 60 years (n, %) ≥ 60 years (n, %) 20 (48.8%) 21 (51.2%) 21 (50%) 21 (50%) Gender Male Female 25 (61%) 16 (39%) 32 (76.2%) 10 (23.8%) Free LIGHT Level at Baseline Mean (range) pg/mL
Slide 9: A Single Dose of CERC-002 Reduced Free LIGHT Levels Dramatically and Rapidly
9| A Single Dose of CERC-002 Reduced Free LIGHT Levels Dramatically and Rapidly Free LIGHT is inhibited by Day 1 and remains low • Mean free LIGHT levels were comparable at baseline across cohorts • Mean free LIGHT levels were about 100 pg/mL higher in the patients ≥ 60 years-old • Free LIGHT levels
Slide 10: Primary Endpoint: Percentage of patients alive and free of respiratory failure at Day 28
10| Primary Endpoint: Percentage of patients alive and free of respiratory failure at Day 28 Robust Treatment Effect Demonstrated in Patients at Greatest Risk of Respiratory Failure and Death CERC-002 treatment led to a greater than 3-fold likelihood of avoiding respiratory failure and death in pati
Slide 11: Proportion of Subjects Requiring Invasive Ventilation
11| Proportion/Percentage of Subjects Requiring Invasive Ventilation Clear trend of CERC-002 reducing the need for invasive ventilation; this effect is driven by events in the ≥ 60-year-old subset of patients Patients ≥ 60 years treated with CERC-002 were twice as likely to avoid invasive ventilatio
Slide 12: COVID-19 related deaths: CERC-002 vs. placebo
12| COVID-19 related deaths: 4 on CERC-002 vs. 9 on placebo (December 2020) 28-day mortality was ~50% lower in patients treated with CERC-002 (3 patients) vs. placebo (6 patients) 60-day follow up data in progress p = 0.19 p = 0.26 p = 0.48 (n = 80) (n = 40) (n = 40) Data on file
Slide 13: Safety and Tolerability
13| Safety and Tolerability • CERC-002 was well-tolerated at a single dose of 16 mg/kg • No serious adverse events attributable to CERC-002 • Majority of AEs judged to be mild or moderate • No evidence of increased infections or adverse events related to immunosuppression CERC-002 N = 40 Placebo N =
Slide 14: Next Steps
14| Next Steps • 60-day safety data expected 1Q 2021 • Plan to present full data at a future scientific meeting • End of phase 2 meeting with FDA to discuss registration trial and filing for Breakthrough Therapy Designation • Severe pediatric onset Crohn’s disease – initial data 1Q 2021 • Currently
Slide 15: www.cerecor.com
www.cerecor.com NASDAQ:CERC