Rebiotix Receives Breakthrough Therapy Designation for RBX2660 – A Microbiota Restoration Therapy (MRT) for the Treatment of Recurrent Clostridium difficile Infection
Milestone reinforces Rebiotix as a leader in microbiota-based drug development and product commercialization
Rebiotix Inc. announced that U.S. Food and Drug Administration (FDA) has designated its lead Microbiota Restoration Therapy (MRT) RBX2660 as a Breakthrough Therapy for the treatment of recurrent Clostridium difficile (C diff) infection, a challenging to treat gastrointestinal (GI) infection that causes 29,000 deaths in the U.S. annually.
Rebiotix is a clinical stage biotechnology company that was founded to revolutionize the treatment of debilitating GI diseases by harnessing the power of the human microbiome. MRT is the Rebiotix drug platform for delivering healthy, live, human-derived microbes into a sick patient’s intestinal tract to treat disease.
Studies have shown that most cases of C diff infection occur after the normal microorganisms that reside in the gut have been disrupted by antibiotic use. Restoring the balance of microbes is thought to be key to breaking the cycle of recurrence. Lead Rebiotix product, RBX2660, is targeted at treating recurrent C diff.
“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,” said Rebiotix CEO Lee Jones. “The Breakthrough Therapy Designation marks the third regulatory milestone for our lead product, RBX2660, in the past two 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.”
About the Breakthrough Therapy Designation
According to the FDA, Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). For more information please visit http://www.fda.gov/forpatients/approvals/fast/ucm405397.htm.
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*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.