C. difficile infection (CDI, picture source: medscape.com)
MGB Biopharma is a biopharmaceutical company focused on developing new anti-infective drugs. Recently, the company announced that the phase II study evaluating the first-line treatment of the new antibacterial drug MGB-BP-3 for C. difficile infection (CDI) has reached the end point of safety, efficacy, and dose selection. Research confirms that MGB-BP-3, as a new antibacterial drug, has the potential to become the new gold standard in the first-line treatment of CDI.
MGB-BP-3 is an antibacterial agent with antibacterial activity against many important multi-drug resistant and sensitive Gram-positive pathogens. The company is developing an oral preparation of MGB-BP-3 for the treatment of CDI.
This phase II dose range study was conducted in the United States and Canada and evaluated three dose levels for the treatment of patients with CDI. As mentioned earlier, the drug showed better efficacy than expected at its lowest dose level (125 mg, twice daily), and this trend was further improved, showing at the second dose level (250 mg, twice daily) The maximum effect. The data shows that taking 250mg dose of MGB-BP-3 twice a day for 10 consecutive days can obtain 100% initial cure and 100% continuous cure. This dosing regimen has now been confirmed for Phase III clinical trials.
The most important goal of developing new drugs for the treatment of CDI is to prevent recurrent diseases and provide continuous cure. MGB-BP-3 achieves this goal through its unique rapid bactericidal activity, a feature that other treatments do not have. Under the 250 mg dose, twice a day, for 10 consecutive days of dosing regimen, MGB-BP-3 was measured 4 weeks after completion of treatment, and no disease recurrence was recorded. In current bacteriostatic treatment, the relapse rate is unacceptably high, and up to one-third of patients undergoing current mainstream treatment regimens will experience disease relapse.
Consistent with the phase I study, MGB-BP-3 showed good safety and tolerability, and neither phase I nor phase II studies reported serious adverse events (SAE).
The lead investigator of the Phase II study, Dr. Thomas Louie, clinical professor at the University of Alberta Cumming School of Medicine, said: "C. difficile infection is a major burden on the Canadian and US medical systems. A new antibiotic can be Pathogens kill spores before they kill them, which gives hope to patients and their families who suffer from the disease."
MGB-BP-3 (Source: medchemexpress.com)
C. difficile infection (CDI) is a serious, often life-threatening infection of the large intestine, and the most common cause of diarrhea in hospitals and nursing homes. In the United States alone, nearly 500,000 cases and approximately 30,000 deaths each year are related to CDI; 3 people die every hour from uncontrolled CDI. CDI has been recognized by the US Centers for Disease Control and Prevention (CDC) as an urgent threatening pathogen, a common consequence of antibiotic treatment in hospitalized patients.
MGB-BP-3 has obtained the Qualified Infectious Disease Product (QIDP) certification from the US Food and Drug Administration (FDA), can quickly submit applications, and has a 5-year long-term exclusive sales right. MGB-BP-3 will also be eligible to participate in the DISARM incentive program under consideration in the United States, which will increase patients’ access to new and innovative treatments.
MGB-BP-3 has a very fast bactericidal effect, which can kill the vegetative bodies of C. difficile before it spores, so as to achieve the initial cure and prevent the relapse of the disease by reducing the total load of C. difficile. In addition, MGB-BP-3 has a strong bactericidal activity against the BI/NAP1/027 strain, and the BI/NAP1/027 strain is currently the most resistant strain.
CDI (Image source: thegastroenterologist.ro)
The speed of action is a key success factor in the treatment of CDI, because C. difficile can exist either in the form of disease-causing vegetative bodies or in the form of dormant spores. Fully developed spores, resistant to any antibacterial treatment, are formed in the harsh environment usually caused by antibiotic treatment. During the sporulation process, the activity of the bacteria to antibiotics remains at least 10 hours sensitive, which provides a period of time for the rapid sterilization antibiotics such as MGB-BP-3 to kill the bacteria.
The current mainstream drugs for treating CDI, vancomycin (vancomycin) and fidaxomicin (fidaxomicin), are both bacteriostatic agents, and it takes more than 24 hours to achieve the maximum effect. These characteristics mean that in many patients, these antibiotics trigger spore formation, and when the spores germinate vegetatively, they cause a high rate of relapse.
Dr. Miroslav Ravic, CEO of MGB Biopharma, said: "We are very pleased to successfully reach our endpoint in the Phase II trial, which is an important milestone for our company. This study identified a dose: The elimination of refractory Clostridium at the same time provides a good balance between the minimal impact on the remaining normal intestinal flora. This leads to a high initial cure rate and prevention of disease recurrence."
Dr. Miroslav Ravic also said: "As the recent COVID-19 pandemic demonstrated, the world urgently needs new anti-infective therapies so that we can better respond to new threats. MGB-BP-3 will be the treatment of CDI Bring a new, greatly improved paradigm that will reduce the morbidity and mortality caused by this terrible infection."