Phase 3 Trial Finds Positive Results for Microbiome Treatment

May 11, 2020 - Rebiotix and Ferring Pharmaceuticals recently announced positive preliminary findings from their ongoing pivotal Phase 3 trial of the investigational microbiome therapy treatment, RBX2660.

The positive trial findings are vital to advance RBX2660 in its clinical development program, which evaluates the safety and efficacy of a standardized, non-antibiotic microbiome-based therapy.

RBX2660 is being developed to decrease C.diff infection recurrences. This is an unmet need for patients and healthcare providers worldwide. The current standard of care is antibiotics, which have been shown to disrupt the microbiome and increase the risk of C.diff recurrence. 

“C. diff infection is a significant public health threat that has limited treatment options. These positive preliminary findings represent a major step forward towards bringing an innovative, non-antibiotic option to patients that may help restore their gut microbiome, Per Falk, president and chief science officer of Ferrings, said in the announcement. 

“With health systems under increasing pressure due to viruses like COVID-19 and the rising threat of antimicrobial resistance, the need for new therapies is greater than ever. We believe the power of the microbiome has great potential and we look forward to bringing RBX2660 to patients soon.”

C.diff causes about 30,000 deaths each year in the US and Europe and recurrences of the infection represent ten to 15 percent of all healthcare-related infections in hospitals annually, the announcement stated. 

RBX2660 may bring an innovative therapeutic option to patients suffering from this potentially deadly infection to restore the microbiome community.

“Since founding Rebiotix in 2011, our mission has been to harness the power of the microbiome to treat complex diseases. Our first goal was to address C. diff, which poses a significant health threat to thousands worldwide every year,” said Lee Jones, CEO and founder of Rebiotix, a Ferring company. 

“The positive preliminary data on the primary efficacy endpoint are a major stepping stone for the RBX2660 development program, bringing us closer to an approved microbiome therapy available for healthcare providers to help patients. As a first-in-class, potentially paradigm-changing technology, we look forward to discussing our final data with the FDA in the latter part of this year.”

The pharmaceutical companies explained that the human microbiome is a complex community of microorganisms that live on every surface of the body. Clinical and scientific studies indicate antibiotics, viruses, stress, and other factors can disturb an individual’s immune system.

This disruption is referred to as “dysbiosis,” and may bring on conditions for infections like C. diff to take hold, they said.

Rebiotix and Ferring stated that there are potential microbiome-based treatments to address similar illnesses. They will continue to evaluate this therapeutic option through their pioneering microbiota-based MRT drug platform. 

The ongoing Phase 3 clinical trial is a randomized, multicenter, double-blinded, placebo-controlled study that incorporates a safety assessment to follow patients for many months following doses of the investigational drug.

The clinical trial builds on nearly ten-years of research of clinical and microbiome data collected over multiple controlled trials. Researchers believe the safety data will give insight into the potential of using microbes as a therapeutic intervention. 

The full data package is anticipated in the second half of 2020.