AV-001 / Vasomune Therap, AnGes MG - LARVOL DELTA

Synthetic Tie2 Agonist AV-001 Protects Against Endothelial Cell Permeability Induced by SARS-CoV-2 Infection/COVID-19 (ATS 2025) - No abstract available

Late-breaking abstract • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Treatment of vascular dementia in female rats with AV-001, an Angiopoietin-1 mimetic peptide, improves cognitive function. (PubMed, Front Neurosci) - "MMI reduces oligodendrogenesis, and induces demyelination, axonal injury and WM injury, and causes memory impairment, while HD-MMI induces increased WM injury and further depression-like behaviors compared to LD-MMI rats. AV-001 has a therapeutic effect on aged female rats with MMI by reducing WM damage and improving neuro-cognitive outcomes."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Depression • Psychiatry • Solid Tumor • ANGPT1

Vasomune Therapeutics Receives US FDA Fast Track Designation for Novel Investigational Medicine AV-001 (Businesswire) - "Vasomune Therapeutics, Inc., has announced today that the US Food and Drug Administration (FDA) granted Fast Track designation for AV-001 for the prevention or treatment of moderate-to-severe ARDS in patients hospitalized with viral and/or bacterial respiratory infections. AV-001 is a first-in-class fully synthetic PEGylated peptide targeting the Tie2 receptor which plays a critical role in vascular stability, barrier integrity and endothelial quiescence, particularly within the pulmonary space."

Fast track • Acute Respiratory Distress Syndrome

A Randomized, Double‑Blind, Placebo‑Controlled Phase1 Single and Multiple‑Dose Pharmacokinetic First‑In‑Human Study of AV‑001 in Healthy Subjects for the Treatment of Acute Respiratory Distress Syndrome (ATS 2024) - "AV-001 Injection was safe and well-tolerated at all doses in both SAD and MAD studies. AV-001 Injection demonstrated linear PK over the dose range studied. The PD of AV-001 Injection demonstrated on-target effects on TELs."

Clinical • Late-breaking abstract • P1 data • PK/PD data • Acute Respiratory Distress Syndrome • Hypotension • Pulmonary Disease • Respiratory Diseases • ANGPT1

Vasomune and AnGes Announce Drug Candidate AV-001 Receives Positive Recommendation from the IDSMB for AV001-004 Phase 2a Study (Businesswire) - "Vasomune Therapeutics...announced today that their lead drug candidate AV-001 has received a positive recommendation from the Independent Data and Safety Monitoring Board (IDSMB) of the AV001-004 Phase 2a Study....'We are pleased to announce that the Independent Data and Safety Monitoring Board recommended the continuation of the Phase 2a trial (NCT05123755) evaluating the efficacy, safety, and tolerability of AV-001 in patients suffering with Acute Respiratory Distress Syndrome (ARDS),'..."

DSMB • Acute Respiratory Distress Syndrome

Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia. (clinicaltrials.gov) - P2a | N=120 | Recruiting | Sponsor: Vasomune Therapeutics, Inc. | Trial completion date: May 2023 ➔ Mar 2025 | Trial primary completion date: Apr 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Treatment with AV-001, an Angiopoietin-1 mimetic peptide, improves dementia outcomes in rats (AAIC 2023) - "AV-001 is a novel therapeutic agent that may improve neurological deficits, memory impairment, and anxiety like behavior in aged female rats subjected to a MMI model of vascular dementia."

Preclinical • Alzheimer's Disease • CNS Disorders • Dementia • Depression • Mood Disorders • Psychiatry • ANGPT1

AV-001 for Hospitalized Patients With COVID-19 Disease (clinicaltrials.gov) - P2a | N=120 | Recruiting | Sponsor: Vasomune Therapeutics, Inc. | Trial completion date: Jun 2022 ➔ May 2023 | Trial primary completion date: May 2022 ➔ Apr 2023

Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

AV-001 for Hospitalized Patients With COVID-19 Disease (clinicaltrials.gov) - P2a; N=120; Recruiting; Sponsor: Vasomune Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

AV-001 for Hospitalized Patients With COVID-19 Disease (clinicaltrials.gov) - P2a; N=120; Not yet recruiting; Sponsor: Vasomune Therapeutics, Inc.

Clinical • New P2a trial • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Vasomune Announces Preliminary Positive Phase 1 Clinical Trial Results for Vascular Normalization Therapy (Businesswire) - P1, N=48; NCT04737486; Sponsor: Vasomune Therapeutics, Inc.; "Vasomune Therapeutics, Inc....announced today positive top-line Phase 1 clinical trial results for AV-001...Results from this study support the advancement of AV-001 to Phase 2a clinical studies in patients with severe COVID-19 disease. Vasomune is co-developing AV-001 with AnGes, Inc. and plans to file a Clinical Trial Application (CTA) for AV-001 with Health Canada....AV-001 was safe and well-tolerated and there were no discontinuations owing to study medication...The pharmacokinetics of AV-001 was consistent across dose groups and after single and multiple injections, thereby providing a wide margin of safety over established threshold levels."

P1 data • Infectious Disease • Novel Coronavirus Disease

A First-in-Human Study of AV-001 in Healthy Subjects (clinicaltrials.gov) - P1; N=48; Completed; Sponsor: Vasomune Therapeutics, Inc.; Recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Novel Coronavirus Disease

A First-in-Human Study of AV-001 in Healthy Subjects (clinicaltrials.gov) - P1; N=48; Recruiting; Sponsor: Vasomune Therapeutics, Inc.

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease

Vasomune Announces FDA Allowance of IND Application For AV-001 for the Treatment of Hospitalized Patients with COVID-19 (Financial Post) - "Vasomune Therapeutics, Inc....announced today the U.S. Food and Drug Administration (FDA) has allowed its Investigational New Drug (IND) application for AV-001...as a potential treatment for hospitalized patients diagnosed with moderate-to-severe COVID-19 disease."

IND • Infectious Disease • Novel Coronavirus Disease