Recent Developments in Microbiome Therapeutics Recent-Developments-in-Microbiome-Therapeutics-Nov | Page 12

Another company with a big focus on Crohn’s Disease is 4D Pharma 54 . The company has built a proprietary platform,
MicroRx, for rapid discovery of bacteria with therapeutic effects. The company has successfully completed a Phase
1B clinical trial for its lead candidate, Blautix, for treating Irritable Bowel Syndrome. In 2016 55 , the company
started Phase 1 clinical trials for another product, Thetanix, to treat Pediatric Crohn’s Disease. Thetanix has been
assigned Orphan Drug status by the FDA. Further, the company is also developing Rosburix, a product for treating
Pediatric Ulcerative Colitis.
Some of the bigger companies in the field of microbiome therapeutics are primarily focused on developing
treatments for Clostridium difficile infections. Vedanta Biosciences 56 , another PureTech Health subsidiary, primed
with a recent funding of $50 million, is getting its lead candidate, VE 303, ready for Phase 1 clinical trial. Its other
lead candidate, VE 202 for Inflammatory Bowel Disease, is expected to enter Phase 1 clinical trial in 2018 57 . The
company has been granted several patents covering compositions of microbial consortia for treatment of diseases.
Synthetic Biologics 58 is a late-stage clinical company with two lead candidates focused on gut disorders. SYN-004
(ribaxamase), an oral tablet, has been designed to protect the gut microbiome from the effects of intravenous beta-
lactam antibiotics for the prevention of Clostridium difficile infection, pathogenic overgrowth and the emergence of
antimicrobial resistance. SYN-010, a proprietary, modified-release formulation of lovastatin lactone, has been designed
to reduce the impact of methane producing organisms in the gut microbiome to treat Irritable Bowel Syndrome with
Constipation (IBS-C). The company completed Phase 2 clinical trials for both SYN-004 and SYN-010 in 2017, and is
now preparing for Phase 3 trials. In May 2017, the US FDA granted SYN-004, a Breakthrough Therapy Designation.
The company is listed on the New York Stock Exchange and trades under the ticker SYN 59 .
The most talked about platform in the industry nowadays, Microbiota Restoration Therapy™, belongs to Rebiotix 60 ,
a clinical stage biotechnology firm. Its lead candidate, RBX2660, an Enema Formulation for prevention of recurrent
Clostridium difficile is currently undergoing a Phase 3 clinical trial. Another product, RBX7455, a lyophilized non-
frozen oral capsule formulation for prevention of recurrent Clostridium difficile, is undergoing Phase 1 clinical
trial. In September 2017, the company raised $8.5 million in convertible note, raising its total funding to $36.3
million to date.
54 https://www.4dpharmaplc.com/
55  http://globalpharmaupdate.com/4d-pharma-starts-dosing-in-phase-1-trial-with-thetanix-to-treat-paediatric-crohns-
disease/
56 https://www.vedantabio.com/
57 
http://puretechhealth.com/our-pipeline/microbiome-derived-immune-modulators-ve303-ve202-ve505
58  https://www.syntheticbiologics.com/
59  https://finance.google.com/finance?q=NYSEMKT:SYN
60 
http://www.rebiotix.com/
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Recent Developments in Microbiome Therapeutics