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Poorly controlled asthma on LABA* and ICS Exacerbation in the last 24 months Blood eosinophil count <300 cells/ L Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of AVTX-002 in patients with NEA PEAK Trial Key Inclusion Criteria Screening AVTX-002 600 mg SC (n=40) Placebo (n=40) Baseline Visit Randomization Discontinue LABA* (W2) 30 Day Run-In Salmeterol/Fluticasone Reduce ICS 50% (W4) Discontinue ICS (W6) Treatment - Days 0, 28, 56 *LABA, long-acting beta-agonist; ICS, inhaled corticosteroid; SABA, short-acting beta agonist; FEV1, forced expiratory volume in 1 second; #FeNO, fractional exhaled nitric oxide; ACQ, asthma control questionnaire.
Carl Ware, PhD, Head of Avalo Scientific Advisory Board - Director, Sanford Burnham Prebys (SBP) Infectious and Inflammatory Diseases Center - Professor, SBP Immunity and Pathogenesis Program - Director, SBP Laboratory of Molecular Immunology Discoverer of LIGHT-signaling network World Class Scientific Advisor 25 Copyright 2023. Avalo Therapeutics.
However, the following positive observations were observed: - AVTX-002 demonstrated a significant and sustained reduction in LIGHT levels - AVTX-002 demonstrated a favorable safety and tolerability profile - Preliminary post-hoc analyses for sub-population of patients with baseline LIGHT levels > 125 pg/mL*: Sub-population represented over 50% of patients Positive trend showed ~50% reduction in AREs for patients treated with AVTX-002 compared to placebo Positive trends were not identified in the secondary endpoints Additional analyses and translational work under consideration to de-risk future studies NEA PEAK Trial Topline Data Executive Summary *Post-hoc analyses are ongoing and therefore preliminary in nature.
Endoscopic improvement: The proportion of subjects with endoscopic improvement, as defined by endoscopy subscore 1 with no friability) at Week 12. Histological Remission The proportion of subjects with histologic remission (defined Geboes score 3.1) at Week 12. IBDQ response: The proportion of subjects with IBDQ response, as defined by 16-point increase from Baseline at Week 12.
Documented diagnosis of UC (endoscopy + histology) confirmed at Screening colonoscopy mMSC of 4 to 9, inclusive, with Modified Mayo endoscopic subscore 2 and rectal bleeding subscore 1. Inadequate response or intolerant to 1 or more of ( IS,aTNF,Vedo, JAK,aIL12/23,S1PR,high dose CS) . Max 70% patients exposed to biologics. Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of quisovalimab in patients with moderate to severe UC who have failed conventional or advanced therapy Key Inclusion Criteria Screening 4 weeks quisovalimab Dose low dose* q2w (n=~50) Placebo (n=~50) Baseline Visit Randomization 12 weeks Treatment - Days 0, 14, 28, 42, 56,70 Clinical Response: The proportion of subjects in 3-component Modified Mayo Score clinical response at Week 12..
Genes Immun. 2013 Oct;14(7):447-52. doi: 10.1038/gene.2013.43. Epub 2013 Aug 22. LIGHT is a member of a select group of key immunomodulator cytokines (TL1A, FasL) that are "regulated" by Decoy Receptor 3 (DcR3) DcR3 loss of function has been associated with autoimmune diseases including Crohn's disease Inflammation, Immunoregulation and Homeostasis Ligands Receptors 6 Copyright 2023.
Positive trends in Crohn's Disease and NEA sub-population. Portfolio emphasizing potential high value, first-in-class biologics focused on dysregulated inflammation via the LIGHT-signaling network AVTX-008 (BTLA agonist fusion protein) - IND enabling stage Avalo Therapeutics (AVTX) Near term catalysts, subject to funding: 1) Initiate quisovalimab Phase 2 POC placebo- controlled trial in UC and 2) File IND for AVTX-008 4 Copyright 2023.
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Change in FEV1 from baseline Time to asthma related event Change in FeNO# from baseline Change in ACQ from baseline quisovalimab for Treatment of NEA: Phase 2 Trial Design Final Visit