? Funded by the Innovative Medicines Initiative (IMI), programs from Da Volterra, MedImmune and the Medicines Company join the COMBACTE-NET Consortium, a foremost network of academic and private partners.
? Da Volterra launches through this consortium an epidemiological study on 1,000 patients in Europe undergoing antibiotics treatments to determine the incidence of Clostridium difficile infections and to better prevent this severe pathology.
? This ambitious initiative with a total budget of 87.3 million Euros is supported by the European Commission and aims at developing a vast network of clinical experts to accelerate the registration and adoption of new products to fight bacterial resistance.
Paris (France), Utrecht (The Netherlands) – 15 November 2016 – Da Volterra, a leading biotechnology company developing a portfolio of unique products in the antibacterial field, with a specific focus on antibiotic resistance, announces today its participation in the European Consortium COMBACTE-NET (Combatting Bacterial Resistance in Europe) alongside MedImmune, the global biologics research and development arm of AstraZeneca, and The Medicines Company.
This Consortium, funded by a budget of 87.3 million Euros, by the European Commission and the EFPIA within the framework of the IMI program (Innovative Medicines Initiative), aims to unite each of the partners with a broad European network of expert hospital physicians and highly capable Good Clinical Practice (GCP) compliant clinical investigation sites to execute clinical trials enabling the registration of novel therapeutic agents effective in the treatment of patients with bacterial infections and antibiotic resistance which represents an increasing global public health threat.
Within the framework of this initiative, Da Volterra is launching an epidemiological study on 1.000 patients recruited in 30 European clinical centers (Netherlands, Germany, Greece, Spain, Romania, France). These patients over 50 years of age, receiving antibiotic treatment, will be followed over a 3 month period to detect any occurrence of Clostridium difficile infections following antibiotic treatment. The objective of this study consists of the detailed analysis of the risk factors for Clostridium difficile infections and in so discerning the populations for which the prevention of this pathology will be the most effective. In effect, Da Volterra is developing a therapeutic solution, designated under the code DAV132, which aims at preventing Clostridium difficile infections in at high-risk patients.
Florence Séjourné, CEO of Da Volterra, declared: “We are very proud to join COMBACTE-NET in the company of such prestigious partners. The means and the expertise engaged in this Consortium are highly equipped to meet the challenges posed by antimicrobial resistance and the infectious risks of the 21th century. Da Volterra is committed since several years in this fight and is positioned as one of the rare companies in the world to have a new therapeutic agent in clinical development stage for the prevention of the Clostridium difficile infections, by protecting the intestinal microbiota from the changes led by antibiotic treatments. In this consortium, we are going to be able to accelerate the clinical development of DAV132 and prepare for Phase 3 study optimally.”
COMBACTE-NET (Combatting Bacterial Resistance in Europe) was the first project of the Innovative Medicines Initiative within its ND4BB program. The project aims to develop a broad European network of fully capable and Good Clinical Practice (GCP) compliant clinical investigation sites to execute clinical trials enabling the registration of novel agents to be used in the treatment of patients with bacterial infections. The network currently comprises more than 750 hospitals, 450 laboratories and over 1,000 investigators in 42 European countries.
***
About Clostridium difficile infections:
In the last decade, the epidemics of Clostridium difficile became even harder to control. Spreading in the environment from infected people whose intestinal flora was disrupted by antibiotic treatments, Clostridium difficile infections raise growing concerns and cause an increasing number of infections. According to a study published in Oct 2015 by the U.S Centers for Disease Control and Prevention (CDC), Clostridium difficile infections cause 500,000 infections and 29,000 deaths per year in the United States1 for a medical cost close to 6 billion dollars2. In Europe, the cost of this pathology is estimated to reach more than 3 billion euros a year3.
About Da Volterra:
Da Volterra is a biopharmaceutical company based in Paris (France) and develops new strategies for the prevention and the treatment of multi-resistant and life-threatening bacterial infections for which the medical need is increasing. While antibiotic resistance threatens current medical practice, Da Volterra’s innovative approaches promise substantial medical progress while fitting the expectations of healthcare professionals. Its most advanced product, DAV132, is developed to prevent Clostridium difficile infections in at highrisk patients.
For more information, visit http://www.davolterra.com.
1 Lessa FC, Mu Y, Bamberg WM, Beldavs ZG, Dumyati GK, Dunn JR, et al. Burden of Clostridium difficile Infection in the United States. N Engl J Med. 2015 Feb 25;372(9):825–34.
2 Zhang S, Palazuelos-Munoz S, Balsells EM, Nair H, Chit A, Kyaw MH. Cost of hospital management of Clostridium difficile infection in United States-a meta-analysis and modelling study. BMC Infect Dis. 25 août 2016;16(1):447.
3 Kuijper EJ, Coignard B, Tüll P, ESCMID Study Group for Clostridium difficile, EU Member States, European Centre for Disease Prevention and Control. Emergence of Clostridium difficile-associated disease in North America and Europe. Clin Microbiol Infect. oct 2006;12 Suppl 6:2-18.
About IMI ND4BB programme:
Innovative Medicines Initiative (IMI) New Drugs 4 Bad Bugs (ND4BB) program has been launched by the European Union and the European Federation of Pharmaceutical Industries and associations (EFPIA).
It represents an unprecedented partnership between industry, academia and biotech organizations to combat antibiotic resistance in Europe by tackling the scientific, regulatory, and business challenges that are hampering the development of new antibiotics. All COMBACTE projects are included within this IMI ND4BB program.
? Da Volterra launches through this consortium an epidemiological study on 1,000 patients in Europe undergoing antibiotics treatments to determine the incidence of Clostridium difficile infections and to better prevent this severe pathology.
? This ambitious initiative with a total budget of 87.3 million Euros is supported by the European Commission and aims at developing a vast network of clinical experts to accelerate the registration and adoption of new products to fight bacterial resistance.
Paris (France), Utrecht (The Netherlands) – 15 November 2016 – Da Volterra, a leading biotechnology company developing a portfolio of unique products in the antibacterial field, with a specific focus on antibiotic resistance, announces today its participation in the European Consortium COMBACTE-NET (Combatting Bacterial Resistance in Europe) alongside MedImmune, the global biologics research and development arm of AstraZeneca, and The Medicines Company.
This Consortium, funded by a budget of 87.3 million Euros, by the European Commission and the EFPIA within the framework of the IMI program (Innovative Medicines Initiative), aims to unite each of the partners with a broad European network of expert hospital physicians and highly capable Good Clinical Practice (GCP) compliant clinical investigation sites to execute clinical trials enabling the registration of novel therapeutic agents effective in the treatment of patients with bacterial infections and antibiotic resistance which represents an increasing global public health threat.
Within the framework of this initiative, Da Volterra is launching an epidemiological study on 1.000 patients recruited in 30 European clinical centers (Netherlands, Germany, Greece, Spain, Romania, France). These patients over 50 years of age, receiving antibiotic treatment, will be followed over a 3 month period to detect any occurrence of Clostridium difficile infections following antibiotic treatment. The objective of this study consists of the detailed analysis of the risk factors for Clostridium difficile infections and in so discerning the populations for which the prevention of this pathology will be the most effective. In effect, Da Volterra is developing a therapeutic solution, designated under the code DAV132, which aims at preventing Clostridium difficile infections in at high-risk patients.
Florence Séjourné, CEO of Da Volterra, declared: “We are very proud to join COMBACTE-NET in the company of such prestigious partners. The means and the expertise engaged in this Consortium are highly equipped to meet the challenges posed by antimicrobial resistance and the infectious risks of the 21th century. Da Volterra is committed since several years in this fight and is positioned as one of the rare companies in the world to have a new therapeutic agent in clinical development stage for the prevention of the Clostridium difficile infections, by protecting the intestinal microbiota from the changes led by antibiotic treatments. In this consortium, we are going to be able to accelerate the clinical development of DAV132 and prepare for Phase 3 study optimally.”
COMBACTE-NET (Combatting Bacterial Resistance in Europe) was the first project of the Innovative Medicines Initiative within its ND4BB program. The project aims to develop a broad European network of fully capable and Good Clinical Practice (GCP) compliant clinical investigation sites to execute clinical trials enabling the registration of novel agents to be used in the treatment of patients with bacterial infections. The network currently comprises more than 750 hospitals, 450 laboratories and over 1,000 investigators in 42 European countries.
***
About Clostridium difficile infections:
In the last decade, the epidemics of Clostridium difficile became even harder to control. Spreading in the environment from infected people whose intestinal flora was disrupted by antibiotic treatments, Clostridium difficile infections raise growing concerns and cause an increasing number of infections. According to a study published in Oct 2015 by the U.S Centers for Disease Control and Prevention (CDC), Clostridium difficile infections cause 500,000 infections and 29,000 deaths per year in the United States1 for a medical cost close to 6 billion dollars2. In Europe, the cost of this pathology is estimated to reach more than 3 billion euros a year3.
About Da Volterra:
Da Volterra is a biopharmaceutical company based in Paris (France) and develops new strategies for the prevention and the treatment of multi-resistant and life-threatening bacterial infections for which the medical need is increasing. While antibiotic resistance threatens current medical practice, Da Volterra’s innovative approaches promise substantial medical progress while fitting the expectations of healthcare professionals. Its most advanced product, DAV132, is developed to prevent Clostridium difficile infections in at highrisk patients.
For more information, visit http://www.davolterra.com.
1 Lessa FC, Mu Y, Bamberg WM, Beldavs ZG, Dumyati GK, Dunn JR, et al. Burden of Clostridium difficile Infection in the United States. N Engl J Med. 2015 Feb 25;372(9):825–34.
2 Zhang S, Palazuelos-Munoz S, Balsells EM, Nair H, Chit A, Kyaw MH. Cost of hospital management of Clostridium difficile infection in United States-a meta-analysis and modelling study. BMC Infect Dis. 25 août 2016;16(1):447.
3 Kuijper EJ, Coignard B, Tüll P, ESCMID Study Group for Clostridium difficile, EU Member States, European Centre for Disease Prevention and Control. Emergence of Clostridium difficile-associated disease in North America and Europe. Clin Microbiol Infect. oct 2006;12 Suppl 6:2-18.
About IMI ND4BB programme:
Innovative Medicines Initiative (IMI) New Drugs 4 Bad Bugs (ND4BB) program has been launched by the European Union and the European Federation of Pharmaceutical Industries and associations (EFPIA).
It represents an unprecedented partnership between industry, academia and biotech organizations to combat antibiotic resistance in Europe by tackling the scientific, regulatory, and business challenges that are hampering the development of new antibiotics. All COMBACTE projects are included within this IMI ND4BB program.
