Swiss pharmaceutical company Roche has announced that it is moving its new antibiotic zosurabalpin, developed to combat infections caused by Acinetobacter baumannii, into phase III trials. If it wins regulatory approval, it will be the first new class of drugs to treat gram-negative bacterial infections in more than 50 years, the Financial Times reports . The company plans to begin trials later this year or early next year.
Roche developed zosurabalpin in collaboration with Harvard University. The drug targets carbapenem-resistant Acinetobacter baumannii. Infections caused by this type of bacteria are particularly resistant to antibiotics due to the presence of a double membrane that protects against most drugs.
The trials will involve about 400 people at risk of death. They will be conducted in more than 100 specialized centers in various countries. Roche expects to file an application for registration of the antibiotic by 2030.
The company's success could lay the groundwork for future efforts to combat antimicrobial resistance (AMR), which could cause an estimated 10 million deaths by 2050. The Centers for Disease Control and Prevention (CDC) considers AMR a major threat.
"Roche hopes that further clinical trials will show that zosurabalpin can help tackle the growing problem of antibiotic resistance and contribute to solving a major public health problem of infectious diseases," the company said.
Acinetobacter baumannii is one of the most dangerous pathogens in hospitals. Roche chose this pathogen because of the urgent need for new antibiotics against it. They are a common cause of hospital-acquired sepsis and other infections, and are at the top of the World Health Organization and CDC list of the most dangerous pathogens.
Along with zosurabalpin, the Swiss pharma giant is also developing another antibiotic with a new mechanism of action, the LepB inhibitor RG6436, which is in early clinical development for the treatment of carbapenem-resistant Gram-negative infections, initially focusing on complicated urinary tract infections (UTIs).
The emergence of a new class of antibiotics is a major event. Drugmakers have been abandoning antimicrobial development en masse in recent decades because it is extremely difficult to recoup investment in development. Typically, to avoid the development of resistance, drugs must be used in limited quantities, exclusively for patients with multidrug-resistant infections. This constrains sales.
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz
Roche developed zosurabalpin in collaboration with Harvard University. The drug targets carbapenem-resistant Acinetobacter baumannii. Infections caused by this type of bacteria are particularly resistant to antibiotics due to the presence of a double membrane that protects against most drugs.
The trials will involve about 400 people at risk of death. They will be conducted in more than 100 specialized centers in various countries. Roche expects to file an application for registration of the antibiotic by 2030.
The company's success could lay the groundwork for future efforts to combat antimicrobial resistance (AMR), which could cause an estimated 10 million deaths by 2050. The Centers for Disease Control and Prevention (CDC) considers AMR a major threat.
"Roche hopes that further clinical trials will show that zosurabalpin can help tackle the growing problem of antibiotic resistance and contribute to solving a major public health problem of infectious diseases," the company said.
Acinetobacter baumannii is one of the most dangerous pathogens in hospitals. Roche chose this pathogen because of the urgent need for new antibiotics against it. They are a common cause of hospital-acquired sepsis and other infections, and are at the top of the World Health Organization and CDC list of the most dangerous pathogens.
Along with zosurabalpin, the Swiss pharma giant is also developing another antibiotic with a new mechanism of action, the LepB inhibitor RG6436, which is in early clinical development for the treatment of carbapenem-resistant Gram-negative infections, initially focusing on complicated urinary tract infections (UTIs).
The emergence of a new class of antibiotics is a major event. Drugmakers have been abandoning antimicrobial development en masse in recent decades because it is extremely difficult to recoup investment in development. Typically, to avoid the development of resistance, drugs must be used in limited quantities, exclusively for patients with multidrug-resistant infections. This constrains sales.
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz
