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Avalo Therapeutics, Inc. (AVTX)

Avalo Therapeutics, Inc. is a precision medicine company in the clinical development phase, dedicated to identifying, advancing, and marketing specialized treatments for patients experiencing critical unmet medical needs across the fields of immunology, immuno-oncology, and rare genetic disorders. Among its key pipeline assets is AVTX-002, a fully human monoclonal antibody designed to inhibit LIGHT. This drug is currently undergoing Phase II clinical trials for non-eosinophilic asthma and inflammatory bowel diseases, specifically moderate to severe Crohn's disease and ulcerative colitis. Furthermore, AVTX-002 is also being investigated in Phase III for its potential to treat acute respiratory distress syndrome caused by COVID-19. The company is also advancing AVTX-007, a fully human monoclonal antibody targeting IL-18, which is progressing through Phase I clinical studies for Still's disease, encompassing both adult-onset Still's disease and systemic juvenile idiopathic arthritis. Avalo's late-stage pipeline includes two products addressing rare genetic conditions, both in Phase III clinical trials: AVTX-801, a D-galactose substrate replacement therapy for phosphoglucomutase 1 deficiency (PGM1), also known as PGM1-CDG; and AVTX-803, an L-fucose substrate replacement therapy intended for LADII, medically referred to as SLC35C1-CDG. Established in 2011, the corporation initially operated as Cerecor Inc. before rebranding as Avalo Therapeutics, Inc. in August 2021. Its main operations are situated in Rockville, Maryland.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Avalo Therapeutics, Inc. logo

Avalo Therapeutics, Inc.

NASDAQ:AVTXHealthcare
-3.63%$7.17
AH$7.17+0.00%vs close
Mkt Cap$384.53M
Float48.59M
O/S53.63M
Vol
$ Vol
RVOL
Inst Own-
SI24.6%
Earnings
Dilution
Avalo Therapeutics, Inc. logoNASDAQ:AVTX$7.17-3.63%
Phase Distribution
22 lead-sponsored trials·0 active·18 completed
Phase 17
Phase 1/21
Phase 211
Phase 2/31
Not applicable2
Status Overview
Completed18
Stopped4

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Status
Phase
  • Phase 2/3
    Completed

    Efficacy and Safety of NFC-1 in Adolescents With Genetic Disorders Impacting mGluR and ADHD

    NFC-1, Placebo

    Attention Deficit Disorder With Hyperactivity

    Enrollment
    101
    Start
    Jun 2016
    Primary Completion
    Feb 2017
    Completion
    Feb 2017
    NCT02777931
  • Phase 2
    Completed

    Antitussive Effects of FP01 Lozenges in Subjects With Cough Due to Upper Respiratory Tract Infection

    FP01

    Acute Cough

    Enrollment
    208
    Start
    May 2012
    Primary Completion
    Sep 2012
    Completion
    Sep 2012
    NCT01597349
  • Phase 2
    Completed

    An Exploratory Study of FP01 Lozenges in Subjects With Chronic Refractory Cough

    FP01, placebo

    Chronic Refractory Cough

    Enrollment
    83
    Start
    Nov 2012
    Primary Completion
    Sep 2013
    Completion
    Sep 2013
    NCT01703923
  • Phase 2
    Completed

    A Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Study of CERC-301 in the Adjunctive Treatment of Subjects With Severe Depression and Recent Active Suicidal Ideation Despite Antidepressant Treatment

    CERC-301

    Major Depressive Disorder

    Enrollment
    1,357
    Start
    Nov 2013
    Primary Completion
    Sep 2014
    Completion
    Oct 2014
    NCT01941043
  • Phase 2
    Terminated

    TARGTEPO Treatment for Anemia in End Stage Renal Disease (ESRD) Patients Undergoing Peritoneal Dialysis (PD)

    MDGN201 TARGTEPO

    Anemia of End Stage Renal Disease

    Enrollment
    2
    Start
    Apr 2015
    Primary Completion
    Jan 2016
    Completion
    Jun 2016
    NCT02378662
  • Phase 2
    Completed

    A Study of Intermittent Doses of CERC-301 in MDD

    CERC-301, Placebo

    Major Depressive Disorder

    Enrollment
    115
    Start
    Jun 2015
    Primary Completion
    Sep 2016
    Completion
    Dec 2016
    NCT02459236
  • Phase 2
    Terminated

    TARGTEPO Treatment for Anemia in PD US Trial

    MDGN201 TARGTEPO, MDGN201 TARGTEPO

    Anemia of End Stage Renal Disease

    Enrollment
    3
    Start
    Jun 2015
    Primary Completion
    May 2016
    Completion
    Sep 2016
    NCT02468414
  • Phase 2
    Completed

    PART A: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and With mGluR Mutations

    AEVI-001, Placebo

    Attention Deficit Hyperactivity Disorder

    Enrollment
    69
    Start
    Aug 2017
    Primary Completion
    Sep 2018
    Completion
    Oct 2018
    NCT03265119
  • Phase 2
    Completed

    PART B: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and Without mGluR Mutations

    AEVI-001, Placebo

    Attention Deficit Hyperactivity Disorder

    Enrollment
    109
    Start
    Aug 2018
    Primary Completion
    Nov 2018
    Completion
    Nov 2018
    NCT03609619
  • Phase 2
    Completed

    Clinical Trial to Evaluate CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury

    CERC-002, Placebo

    COVID-19 Pneumonia, Acute Lung Injury +1

    Enrollment
    88
    Start
    Jul 2020
    Primary Completion
    Dec 2020
    Completion
    Jan 2021
    NCT04412057
  • Phase 2
    Completed

    A Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma.

    AVTX-002, Placebo

    Non-Eosinophilic Asthma

    Enrollment
    91
    Start
    Feb 2022
    Primary Completion
    May 2023
    Completion
    May 2023
    NCT05288504
  • Phase 2
    Completed

    A Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis Suppurativa

    AVTX-009 Regimen 1, AVTX-009 Regimen 2

    Hidradenitis Suppurativa

    Enrollment
    253
    Start
    Sep 2024
    Primary Completion
    Feb 2026
    Completion
    Mar 2026
    NCT06603077
  • Phase 1/2
    Completed

    TARGTEPO Treatment for Anemia in Chronic Kidney Disease (CKD) Patients and End-Stage Renal Disease (ESRD)

    MDGN201 TARGTEPO

    Chronic Kidney Disease, End Stage Renal Disease

    Enrollment
    11
    Start
    May 2014
    Primary Completion
    Jun 2016
    Completion
    Mar 2017
    NCT02117427
  • Phase 1
    Completed

    A Single Dose Study to Determine the Safety and Pharmacokinetics of FP01 Lozenges in Healthy Volunteers

    FP01

    Healthy

    Enrollment
    40
    Start
    Apr 2012
    Primary Completion
    Apr 2012
    Completion
    May 2012
    NCT01579526
  • Phase 1
    Completed

    Phase I Single Dose, Open-Label Pharmacokinetic Study and Single-Blind, Placebo-Controlled Dose Escalation Study of NFC-1 in Adolescents With Attention-Deficit Hyperactivity Disorder

    NFC-1

    Attention-deficit Hyperactivity Disorder (ADHD)

    Enrollment
    30
    Start
    Jan 2015
    Primary Completion
    May 2015
    Completion
    Mar 2016
    NCT02286817
  • Phase 1
    Completed

    Safety and Efficacy Study of NFC-1 in Subjects Aged 12-17 Years With 22q11.2DS & Associated Neuropsychiatric Conditions

    NFC-1

    22q11.2 Deletion Syndrome

    Enrollment
    2
    Start
    Nov 2016
    Primary Completion
    Apr 2017
    Completion
    Apr 2017
    NCT02895906
  • Phase 1
    Completed

    Pharmacokinetic and Tolerability Study of NFC-1 in Subjects Aged 6-17 Years With ADHD

    NFC-1 100 mg, NFC-1 200 mg

    Attention Deficit Disorder With Hyperactivity

    Enrollment
    32
    Start
    Jan 2017
    Primary Completion
    Feb 2017
    Completion
    Mar 2017
    NCT03006367
  • Phase 1
    Terminated

    Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis

    MDGN-002

    Crohn Disease, Ulcerative Colitis

    Enrollment
    8
    Start
    Jul 2017
    Primary Completion
    Sep 2021
    Completion
    Oct 2021
    NCT03169894
  • Phase 1
    Completed

    Phase 1b Study of AEVI-007 in Subjects With Relapsed or Refractory Multiple Myeloma

    AEVI-007

    Multiple Myeloma

    Enrollment
    13
    Start
    Dec 2020
    Primary Completion
    Mar 2022
    Completion
    Mar 2022
    NCT04671251
  • Phase 1
    Withdrawn

    A Pharmacokinetic, Pharmacodynamic, Safety and Tolerability Study of CERC-006 in Adults With Complex Lymphatic Malformations

    CERC-006

    Lymphatic Malformation

    Enrollment
    0
    Start
    Sep 2021
    Primary Completion
    Jun 2022est.
    Completion
    Jun 2022est.
    NCT04994002
  • Observational
    Completed

    A Noninterventional Genotype/Phenotype Study of mGluR Mutations in Children and Adolescents With ADHD

    -

    Attention Deficit Disorder With Hyperactivity

    Enrollment
    1,894
    Start
    Feb 2016
    Primary Completion
    Jan 2017
    Completion
    Jan 2017
    NCT02811211
  • Observational
    Completed

    A Non-interventional Study to Identify Children and Adolescents With ADHD and With or Without mGLuR Mutations

    -

    Attention Deficit Hyperactivity Disorder

    Enrollment
    2,503
    Start
    Aug 2017
    Primary Completion
    Aug 2018
    Completion
    Aug 2018
    NCT03233867
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