anti-shiga toxin hyperimmune equine immunoglobulin F(ab')2 fragment (INM004) / Inmunova - LARVOL DELTA

Role of INM004 Shiga-toxin antibodies in treatment of STEC-HUS. (PubMed, Pediatr Nephrol) - No abstract available

Journal

Open-label, controlled, phase 2 clinical trial assessing the safety, efficacy, and pharmacokinetics of INM004 in pediatric patients with Shiga toxin-producing Escherichia coli-associated hemolytic uremic syndrome. (PubMed, Pediatr Nephrol) - "INM004 showed an adequate safety profile. Efficacy non-statistically significant trends suggesting a beneficial effect in the amelioration of kidney injury were observed. These results encourage the conduction of a phase 3 study of INM004 in pediatric patients with STEC-HUS."

Journal • P2 data • PK/PD data • Acute Kidney Injury • Atypical Hemolytic Uremic Syndrome • Nephrology • Pediatrics • Renal Disease

Innovative inmunotherapy: INM004 background. Past clinical trials, results (phase II trials) (ESPN 2024) - "Sponsored by CHEMO-INMUNOVA"

Clinical • P2 data

Efficacy of INM004 in Children With STEC-HUS (clinicaltrials.gov) - P3 | N=220 | Recruiting | Sponsor: Inmunova S.A. | Not yet recruiting ➔ Recruiting

Enrollment open • Atypical Hemolytic Uremic Syndrome • Nephrology • Pediatrics

A Phase III Study to Evaluate the Efficacy of INM004 in Children With STEC-HUS (clinicaltrials.gov) - P3 | N=220 | Not yet recruiting | Sponsor: Inmunova S.A.

New P3 trial • Atypical Hemolytic Uremic Syndrome • Nephrology • Pediatrics

A phase I study to evaluate the safety, tolerance and pharmacokinetics of anti-Shiga toxin hyperimmune equine F (ab') fragments in healthy volunteers. (PubMed, Br J Clin Pharmacol) - "The results obtained in this first-in-human study support progression into the phase 2 trial in children with HUS."

Clinical • Journal • P1 data • PK/PD data • Atypical Hemolytic Uremic Syndrome • Inflammation • Pain

A Study to Assess Safety, Efficacy, and Pharmacokinetics of INM004 in Pediatric Patients With STEC-HUS (clinicaltrials.gov) - P2 | N=57 | Completed | Sponsor: Inmunova S.A. | Active, not recruiting ➔ Completed | N=100 ➔ 57

Enrollment change • Trial completion • Atypical Hemolytic Uremic Syndrome • Infectious Disease • Nephrology • Pediatrics • Renal Disease

Phase 2/3 Study to Evaluate PK, Safety & Efficacy of INM004 in STEC Positive Pediatric Patients for Prevention of HUS (clinicaltrials.gov) - P2/3 | N=11 | Terminated | Sponsor: Inmunova S.A. | N=396 ➔ 11 | Suspended ➔ Terminated; Due to COVID pandemia enrolment was stopped on 20March2020

Enrollment change • Trial termination • Atypical Hemolytic Uremic Syndrome • Nephrology • Pediatrics • Renal Disease

A Study to Assess Safety, Efficacy, and Pharmacokinetics of INM004 in Pediatric Patients With STEC-HUS (clinicaltrials.gov) - P2 | N=100 | Active, not recruiting | Sponsor: Inmunova S.A. | Recruiting ➔ Active, not recruiting

Enrollment closed • Atypical Hemolytic Uremic Syndrome • Infectious Disease • Nephrology • Pediatrics • Renal Disease

A Study to Assess Safety, Efficacy, and Pharmacokinetics of INM004 in Pediatric Patients With STEC-HUS (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Inmunova S.A. | Not yet recruiting ➔ Recruiting

Enrollment open • Atypical Hemolytic Uremic Syndrome • Infectious Disease • Nephrology • Pediatrics • Renal Disease

A Study to Assess Safety, Efficacy, and Pharmacokinetics of INM004 in Pediatric Patients With STEC-HUS (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Inmunova S.A.

New P2 trial • Atypical Hemolytic Uremic Syndrome • Infectious Disease • Nephrology • Pediatrics • Renal Disease

Phase 2/3 Study to Evaluate PK, Safety & Efficacy of INM004 in STEC Positive Pediatric Patients for Prevention of HUS (clinicaltrials.gov) - P2/3 | N=396 | Suspended | Sponsor: Inmunova S.A. | Trial completion date: Sep 2022 ➔ Sep 2025 | Trial primary completion date: Mar 2022 ➔ Mar 2025

Trial completion date • Trial primary completion date • Atypical Hemolytic Uremic Syndrome • Nephrology • Pediatrics • Renal Disease

Phase 2/3 Study to Evaluate PK, Safety & Efficacy of INM004 in STEC Positive Pediatric Patients for Prevention of HUS (clinicaltrials.gov) - P2/3; N=396; Suspended; Sponsor: Inmunova S.A.; Recruiting ➔ Suspended

Clinical • Trial suspension • Atypical Hemolytic Uremic Syndrome • Nephrology • Pediatrics • Renal Disease

Generation of a human iPSC line, INMi004-A, with a point mutation in CRX associated with autosomal dominant Leber congenital amaurosis. (PubMed, Stem Cell Res) - "The generated iPSC line contained the congenital deletion c.695delC in exon 4 of CRX, had a normal karyotype, and was capable of differentiation into all three germ layers. This cell line represents an important tool to study the pathophysiology of CRX-associated LCA."

Journal • Gene Therapies • Genetic Disorders • Ophthalmology