Last week, Ferring-owned microbiome firm Rebiotix reported positive preliminary findings from its phase 3 trial for RBX2660 – an investigational, non-antibiotic, microbiome-based therapy developed to reduce Clostridioides difficile (C. diff) infection recurrences.

The ongoing phase 3 trial is a randomized, multi-centre, double-blinded, placebo-controlled study involving 270-patients. Full data is anticipated in the second half of 2020. However, preliminary data on primary endpoints for infection recurrence have been positive, says the company.

“C. diff infection is a significant public health threat that has limited treatment options,” commented Per Falk, Ferring’s President and Chief Science Officer. “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.”

Lee Jones, CEO and founder of Rebiotix says 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 company said the positive efficacy findings mark an important milestone, advancing RBX2660 in its clinical development program with a goal of bringing a US FDA approved therapy to patients.

“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,” said Falk.

While the positive result for RBX2660 is obviously great news for Rebiotix and Ferring, the fact that these are the first positive results from a phase 3 clinical trial in the microbiome space mean it is also so much more. It is a validation for everyone else on the journey too.

The canary in the coal mine

Many years ago, men would go to work into a coal mine with a canary.

They knew that the mine tunnels could contain toxic gasses. But they also knew that if the mines did contain these gasses the bird would die – and so the men could make their escape before the gasses killed them too.

This trial was a canary in the coal mine for the rest of the microbiome space. If it had failed, there would have been huge consequences.

Instead, we now know that the first canary we sent into coal mine has survived. And that is great news for the many others still down there.

Of course, not all of the trials in this space will be successful. It is unrealistic to think that every investigation and research pipeline will bring a golden ticket. But the fact that the first trial has been successful is bound to put a spring in the step of people well beyond those directly involved.

It will energise the already bullish attitude of companies working on microbiome-related pipelines. It will further buoy investor sentiment in the space. It will mean sceptical bystanders have to start taking the avenues being explored by microbiome therapeutics more seriously.

For all of those reasons and more, this is not just a good result for Rebiotix, it is a good result for everyone.

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Nathan Gray
Nathan Gray is an editor, event producer and science communicator with a wealth of experience in B2B media and extensive expertise in the food, nutrition and wellness sector. He has written on microbiome-related topics for more than a decade for publications including NutraIngredients, Natural Products Insider and Microbiome Post, in addition to planning and chairing the global Probiota event and related online conferences and webinars on probiotics, prebiotics and microbiome therapies. Nathan is Managing Director of Nutraceutic, a UK-based consultancy specialising in content, market insights and events. He is also director of science and technology at the Global Prebiotic Association and Trust Transparency Center.