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FDA Grants QIDP Designation to MGB-BP-3 to Treat Clostridium difficile-associated Diarrhea

SEP 12, 2016 | KRISTI ROSA
The US Food and Drug Administration (FDA) has granted biopharmaceutical company, MGB Biopharma’s lead candidate, MGB-BP-3, Qualified Infectious Disease Product (QIDP) designation for the treatment of Clostridium difficile-associated Diarrhea (CDAD), according to a recent press release.

This antibacterial has proven to be effective against a range of both multi-resistant and susceptible Gram-positive pathogens. According to the press release, an oral formulation of MGB-BP-3 has been developed to specifically target and treat C. difficile-associated disease (CDAD), which is caused by a ribotype (B1/NAP1/027) that is known to be the cause of high morbidity and mortality in patients with C. difficile infection.

Clostridium difficile is a bacterium that inflames the colon, otherwise referred to as colitis, according to the Centers for Disease Control and Prevention (CDC). The bacteria are found within feces and individuals can become infected if their mucous membranes come into contact with a contaminated surface or object. This process of transmission makes C. difficile accountable for a high number of hospital-acquired diarrhea cases throughout developed countries.

MSB-BP-3’s clinical Phase I study found that the antibiotic did not have any effect on the permeability of the intestines, was not systematically absorbed, and was overall, well-tolerated by healthy participants. In an effort to gauge how safe and effective MSB-BP-3 is, MGB Biopharma is preparing for Phase II of the clinical study.

In 2012, Congress established the QIDP designation program, which is a part of the Generating Antibiotic Incentives Now Act (GAIN) that set out to entice drug manufacturers to develop new novel antibiotics specifically for dangerous infections that have developed resistance to the currently available treatment options, according to the press release. MGB Biopharma is one of these companies, one that seeks to develop a “novel class of anti-infectives,” thus assisting in the worldwide fight against antibiotic resistance.

The CEO of MGB Biopharma, Miroslav Ravic, MD, PhD, said, “We are very pleased with the FDA’s decision to grant QIDP designation to MGB-BP-3 as we believe this drug has the potential to provide a significant benefit in the treatment of Clostridium difficile-associated Diarrhea (CDAD). Granting of the QDIP designation highlights the potential of MGB-BP-3 to address serious and life threatening infections and is an important milestone in the development of our lead product, as we prepare to initiate the Phase II clinical trial.”

Researchers around the globe are participating in the fight against antibiotic-resistant pathogens. Additional advancements have been made in understanding Clostridium difficile, such as the work being done at the University of Texas Health Science Center and the Graduate School of Biomedical Sciences in Houston, which has provided researchers with insight into how C. difficile bacteria produce toxins, which can direct researchers in the development of other non-antibiotic drugs that can fight these dangerous infections.

Researchers at the Memorial Sloan Kettering Cancer Center have also reviewed recent studies that closely examine the role that probiotics play in the fight against life-threatening drug-resistant pathogens such as C. difficile, that have developed resistance to antibiotics.

When speaking of this global effort, Dr. Ravic said, “Around the world, governments and global organizations are calling for new anti-bacterial drugs and are introducing incentives to reward companies for delivering these products; only last week antimicrobial resistance (AMR) was on the agenda of the G20 Summit. Our MGB anti-infectives have the potential to deliver significant advantages over current approaches.”
 
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