FDA News

FDA designates recurrent C. difficile treatment as breakthrough therapy

The FDA has issued breakthrough therapy designation to RBX2660, a microbiota restoration therapy for recurrent Clostridium difficile infection, the manufacturer announced.

“The development of RBX2660 represents our commitment to harnessing the microbiome to develop therapies for debilitating and sometimes fatal disease for which there is currently no FDA-approved alternative,” Rebiotix CEO Lee Jones said in a press release. “The breakthrough therapy designation marks the third regulatory milestone for our lead product, RBX2660, in the past 2 years, and reinforces our leading efforts that have brought us to the cusp of delivering a revolutionary and validated treatment to patients living with recurrent C. diff.

According to the press release, Microbiota Restoration Therapy is the company’s drug platform for delivering healthy, live, human-derived microbiota into the intestinal tract.  Previous studies have demonstrated the majority of C. difficile infections occur after the normal gut microbiome is disrupted by antibiotics, and “restoring the balance of microbes is thought to be key to breaking the cycle of recurrence,” the release said.

RBX2660, Rebiotix’s lead candidate, was also previously granted orphan drug status and fast track status by the FDA, according to the press release.

Disclosures: Jones reports he is an employee of Rebiotix.

The FDA has issued breakthrough therapy designation to RBX2660, a microbiota restoration therapy for recurrent Clostridium difficile infection, the manufacturer announced.

“The development of RBX2660 represents our commitment to harnessing the microbiome to develop therapies for debilitating and sometimes fatal disease for which there is currently no FDA-approved alternative,” Rebiotix CEO Lee Jones said in a press release. “The breakthrough therapy designation marks the third regulatory milestone for our lead product, RBX2660, in the past 2 years, and reinforces our leading efforts that have brought us to the cusp of delivering a revolutionary and validated treatment to patients living with recurrent C. diff.

According to the press release, Microbiota Restoration Therapy is the company’s drug platform for delivering healthy, live, human-derived microbiota into the intestinal tract.  Previous studies have demonstrated the majority of C. difficile infections occur after the normal gut microbiome is disrupted by antibiotics, and “restoring the balance of microbes is thought to be key to breaking the cycle of recurrence,” the release said.

RBX2660, Rebiotix’s lead candidate, was also previously granted orphan drug status and fast track status by the FDA, according to the press release.

Disclosures: Jones reports he is an employee of Rebiotix.