Safety and effectiveness of RBD-specific polyclonal equine F(ab´)2 fragments for the treatment of hospitalized patients with severe Covid-19 disease: A retrospective cohort study

Salazar, Diego H Farizano; Achinelli, Fernando; Colonna, Mariana; Pérez, Lucía; Giménez, Analía A; Ojeda, Maria Alejandra; Puente, Susana N Miranda; Negrette, Lía Sánchez; Cañete, Florencia; Ibarra, Ornela I Martelotte; Sanguineti, Santiago; Spatz, Linus; Goldbaum, F.A.; Massa, Carolina; Rivas, Marta; Pichel, Mariana; Hiriart, Yanina; Zylberman, Vanesa; Gallego, Sandra; Konigheim, Brenda; Fernández, Francisco Arnalich; Deprati, Matías; Roubicek, Ian; Giunta, Diego; Nannini, Esteban C.; Lopardo, Gustavo

doi:10.1371/journal.pone.0274796

Cited by 3 publications

References 31 publications

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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

Fayad,

Principi,

Balestracci

et al. 2024

Pediatr Nephrol

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Background Shiga toxin-producing Escherichia coli-associated hemolytic uremic syndrome (STEC-HUS) is a severe condition mainly affecting children. It is one of the leading causes of acute kidney injury in the pediatric population. There is no established therapy for this disease. INM004 is an anti-Shiga toxin composed of equine polyclonal antibodies. This study is aimed at assessing the safety, pharmacokinetics, and efficacy of INM004 in pediatric patients with STEC-HUS. Methods Phase 2, open-label clinical trial with an historical control arm. Patients in the treatment arm received two doses of INM004. The primary endpoints were the safety profile, pharmacokinetics, and efficacy (dialysis days) of INM004. Secondary endpoints included other kidney and extrarenal outcomes. Propensity score matching was used for efficacy comparisons between arms. Results Fifty-seven and 125 patients were enrolled in the treatment and control arm, respectively. After propensity score matching, 52 patients remained in each arm. INM004 was well-tolerated. Eight adverse events were considered possibly related, none of which were serious or severe. In the primary efficacy endpoint, patients of the treatment arm presented a non-statistically significant difference of two dialysis days. On secondary endpoints, non-statistically significant trends toward fewer patients needing dialysis and dialysis for more than 10 days, and shorter time to glomerular filtration rate normalization, were observed favoring the treatment arm. Conclusions 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. Graphical Abstract

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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

Fayad,

Principi,

Balestracci

et al. 2024

Pediatr Nephrol

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SARS-CoV-2 ferritin nanoparticle vaccines produce hyperimmune equine sera with broad sarbecovirus activity

Martinez,

Chang,

Chen

et al. 2024

iScience

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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

Fayad,

Principi,

Balestracci

et al. 2024

Preprint

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Background Shiga toxin-producing Escherichia coli-associated hemolytic uremic syndrome (STEC-HUS) is a severe condition mainly affecting children. It is one of the leading causes of acute kidney injury in pediatric population. There is no established therapy for this disease. INM004 is an anti-Shiga toxin composed of equine polyclonal antibodies. This study aimed to assess the safety, pharmacokinetics, and efficacy of INM004 in pediatric patients with STEC-HUS. Methods Phase 2, open-label clinical trial with an historical control arm. Patients in the treatment arm received two doses of INM004. The primary endpoints were the safety profile, pharmacokinetics, and efficacy (dialysis days) of INM004. Secondary endpoints included other renal and extrarenal outcomes. Propensity score matching was used for efficacy comparisons between arms. Results Fifty-seven and 125 patients were enrolled in the treatment and control arm, respectively. After propensity score matching, 52 patients remained in each arm. INM004 was well-tolerated. Eight adverse events were considered possibly related, none of which were serious or severe. In the primary efficacy endpoint, patients of the treatment arm presented a non-statistically significant difference of two dialysis days. On secondary endpoints, trends toward a lower number of patients needing dialysis and dialysis for more than ten days, and shorter time to glomerular filtration rate normalization, were observed favoring the treatment arm. Conclusions INM004 showed an adequate safety profile. Efficacy 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.

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Safety and effectiveness of RBD-specific polyclonal equine F(ab´)2 fragments for the treatment of hospitalized patients with severe Covid-19 disease: A retrospective cohort study

Cited by 3 publications

References 31 publications

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

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

SARS-CoV-2 ferritin nanoparticle vaccines produce hyperimmune equine sera with broad sarbecovirus activity

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

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