Hemolytic uremic syndrome (HUS) is a serious ilness caused by consuming food or water contaminated with the Shiga toxin producing Escherichia coli bacteria.
Argentina is the country with the highest incidence of HUS in the world with more than 300 cases per year.
This rare disease leaves serious after-effects and can be fatal. There is still no specific treatment approved anywhere in the world. Protocols recommend supportive therapy in a hospital setting.
Children are most likely to be affected but adults can get it as well.
It is the first cause of acute renal failure in children.
It accounts for 10% of pediatric kidney transplants.
It leaves sequels for life in 50% of the affected children: chronic kidney failure, hypertension and neurological disorders.
According to the OMS, Argentina has the highest global incidence of HUS in children under 5 years of age. Other countries in North America, Europe, or Asia have outbreaks of the disease.
It can be diagnosed by a laboratory test that detects the toxin’s presence in few hours.
At Inmunova we have developed an innovative biological drug (INM004) with the potential to be the first treatment to block Shiga toxin and prevent severe forms of HUS.
INM004 contains F(ab’)2 fragments of broad-spectrum polyclonal antibodies that can recognize and neutralize different variants of Shiga toxin.
Neutralizing capacity against Stx was demonstrated in cell lines and animal models, in studies conducted at the Centro de Medicina Comparada del Instituto de Ciencias Veterinarias
del Litoral (Universidad Nacional del Litoral / CONICET) and in specialized laboratories in the United States.
The safety of INM004 was evaluated in healthy adult volunteers. The clinical trial was conducted in collaboration with the Clinical Pharmacology team of Hospital Italiano de Buenos Aires. The results showed an adequate safety profile and supported progression to the next clinical stage in pediatric patients.
The clinical trial was conducted at 16 hospitals and clinics across Argentina to evaluate the safety and efficacy of INM004 in pediatric patients with an early diagnosis of HUS. The results showed that the therapy is safe (no significant adverse events were observed) and potentially useful for the treatment of the disease.
In 2024, the phase 3 of the clinical research began at 20 hospitals and clinics in Argentina, and subsequently at 20 further sites in eight European countries. At this stage, the efficacy of
INM004 will be assessed in pediatric patients diagnosed with HUS and requiring hospitalization, considering the time to recovery of renal function and the prevention/duration of dialysis during the acute phase of STEC-HUS.
Buenos Aires: Hospital Interzonal Especializado Materno Infantil Don Victorio Tetamanti (Mar del Plata) – Clínica del Niño y la Madre (Mar del Plata) – Hospital De Niños «Sor María Ludovica» (La Plata) – Hospital Interzonal General de Agudos “Dr. José Penna” (Bahía Blanca)* / CABA: Clínica Zabala – Sanatorio Güemes – Hospital de Niños Dr. Ricardo Gutiérrez – Sanatorio Anchorena – Hospital Prof. Dr. Juan P. Garrahan / Córdoba: Hospital de Niños de la Santísima Trinidad – Sanatorio Allende – Hospital Privado Centro Médico de Córdoba – Hospital San Antonio de Padua (Río Cuarto) / Mendoza: Hospital Pediátrico Dr. Humberto J. Notti – Hospital Schestakow (San Rafael) / Neuquén: Clínica Pediátrica San Lucas / Salta: Hospital Público Materno Infantil / Santa Fe: Instituto de Medicina y Cirugía Infantil. Sanatorio de Niños (Rosario) – Hospital de Niños Zona Norte Dr. Roberto Carra (Rosario) / Tucumán: Hospital de Clínicas Pte. Nicolás Avellaneda / San Luis: Hospital Pediátrico San Luis
*Próximo a activarse
Argentina
Buenos Aires: Hospital Interzonal Especializado Materno Infantil Don Victorio Tetamanti (Mar del Plata) – Clínica del Niño y la Madre (Mar del Plata) – Hospital De Niños «Sor María Ludovica» (La Plata) – Hospital Interzonal General de Agudos “Dr. José Penna” (Bahía Blanca) – Hospital El Cruce Dr. Néstor Kirchner (Florencio Varela) / CABA: Clínica Zabala – Sanatorio Güemes – Hospital de Niños Dr. Ricardo Gutiérrez – Sanatorio Anchorena – Hospital Prof. Dr. Juan P. Garrahan – Hospital General de Niños Pedro de Elizalde / Córdoba: Hospital de Niños de la Santísima Trinidad – Hospital Privado Centro Médico de Córdoba – Hospital San Antonio de Padua (Río Cuarto) / Mendoza: Hospital Pediátrico Dr. Humberto J. Notti – Hospital Schestakow (San Rafael) / Salta: Hospital Público Materno Infantil / Santa Fe: Instituto de Medicina y Cirugía Infantil. Sanatorio de Niños (Rosario) – Hospital de Niños Zona Norte Dr. Roberto Carra (Rosario) / Tucumán: Hospital de Clínicas Pte. Nicolás Avellaneda
Europe
France: Hôpital Femme Mère Enfant (Lyon) – Hôpital universitaire Robert-Debré (Paris) – Hôpital Armand-Trousseau (París) – CHU Montpellier (Montpellier) – CHU De Bordeaux (Bordeaux) – Hôpital Necker-Enfants malades (Paris) – CHU Nantes (Nantes) – CHU Rouen (Rouen) – CHU Toulouse (Toulouse) / United Kingdom: Royal Hospital for Children, Glasgow (Glasgow) – Bristol Royal Hospital for Children (Bristol) – Great Ormond Street Hospital for Children (Londres) / Romania: Spitalul Clinic de Urgență pentru Copii Cluj-Napoca (Napoca) – Spitalul Clinic de Urgență pentru Copii “Marie Sklodowska Curie” (Bucarest) – Spitalul Clinic de Urgenta Timisoara (Timisoara) – Spitalul Clinic de Urgență pentru Copii «Louis Țurcanu» Timişoara (Timisoara) / Italy: Azienda Ospedaliero Universitaria Policlinico Bari (Bari) – Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico di Milano (Milán) – Istituto Giannina Gaslini (Genova) – Policlinico Sant’Orsola (Bologna) – Azienda Ospedale Università Padova (Padova) / Germany: Universitätsklinikum Heidelberg AöR (Heidelberg) – Universitätskinderklinik Erlangen (Erlangen) / Belgium: Cliniques universitaires Saint-Luc (Bruselas)
We work to translate advanced science and innovation into therapies that have a significant impact on improving health.
