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Synthetic Biologics’ Ribaxamase Setback Shows Difficulty Of C. Difficile Development

 
• By Emily Hayes

Company believes there is a path forward for developing ribaxamase in Phase III, based on discussions with the FDA, but deaths in Phase II meant loss of breakthrough designation.

Business decline

Although Synthetic Biologics Inc.’ C. difficile microbiome therapy SYN-004 (ribaxamase) lost its breakthrough designation from the US FDA, looking ahead the company is focusing on the security of having a Phase III design approved by the agency. The latest setback is a sign of the challenges of the development space, which is marked by a number of trial failures.

C. difficile is a spore-forming pathogen that typically causes symptoms in individuals with altered gut microbial flora, releasing toxins. Diarrhea,...

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EADV: Leo Makes A Big Leap With Eczema Drug Temtokibart Set For Phase III

 
• By Kevin Grogan

CSO Jacob Thyssen tells Scrip that the monoclonal antibody which blocks the IL-22RA1 receptor subunit is a very safe and effective option to treat the chronic inflammatory skin disease.

Incyte’s Povorcitinib Wins Stack Up, Will It Be Enough To Hedge Jakafi Loss?

 
• By Aakash Babu

With patent expiry for its blockbuster blood cancer drug Jakafi on the horizon, Incyte will need to translate these povorcitinib wins from clinic to market.

Regeneron’s Garetosmab May Become Second Drug For Rare Bone Disease FOP

 
• By Alaric DeArment

The company announced positive Phase III data for the drug in fibrodysplasia ossificans progressiva, as well as Phase II combination data among patients with obesity.

Roivant Sets The Stage For Commercial Return With Brepocitinib Data

 
• By Jessica Merrill

Positive Phase III data positions Roivant to launch the oral TYK2/JAK1 inhibitor for dermatomyositis, with an NDA filing planned in early 2026.

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Roivant Sets The Stage For Commercial Return With Brepocitinib Data

 
• By Jessica Merrill

Positive Phase III data positions Roivant to launch the oral TYK2/JAK1 inhibitor for dermatomyositis, with an NDA filing planned in early 2026.

AstraZeneca’s Fasenra RESOLUTE Failure Highlights The Limits Of Biologics In COPD

 
• By Alexandra Shimmings

AstraZeneca’s IL-5 blocker has again missed in COPD, adding to a number of disappointments for biologics in this disease. Complex biology and overlapping inflammatory pathways seem to be at the heart of the problem.

Lilly’s Orforglipron Bests Novo Rival In First Oral Head-To-Head Study

 
• By Andrew McConaghie

The company’s cardiometabolic leader Ken Custer discusses the topline ACHIEVE-3 results in diabetes and just-published full results of ATTAIN-1 in obesity of orforglipron, with a pledge to maximize access to the oral GLP-1 therapy worldwide, once approved.