Active Digestion, Kidneys & Other Organs Infection & Immunity

Safety and Clinical Efficacy of Ovine Polyclonal Antibodies (OraCAb) for the Treatment of Mild, Moderate and Severe Clostridioides Difficile Infection (CDI)

In plain English

AI plain-English summary

A single oral dose of antibodies harvested from sheep could replace the current standard of care for severe *C. difficile* infections, a gut infection that kills thousands of patients each year. The problem is that existing treatments for *C. difficile*—antibiotics like vancomycin and fidaxomicin—are blunt instruments. They kill the bacteria but do not neutralise the two toxins (TcdA and TcdB) that actually damage the gut lining and cause life-threatening inflammation. Many patients relapse after treatment because the toxins linger. This project tests whether a liquid suspension of purified sheep antibodies, called OraCAb, can safely bind and neutralise those toxins directly in the gut, regardless of the severity of the infection. If the clinical trial in Kenya and Australia shows that OraCAb is safe and reduces symptoms, it would offer a fundamentally different approach: a targeted, toxin-neutralising therapy that works alongside antibiotics. For patients with severe CDI, this could mean faster recovery, fewer relapses, and lower mortality. For the health system, it could reduce the need for intensive care and repeated hospital stays. The manufacturing process—raising antibodies in sheep—is also relatively low-cost and scalable, which matters for a disease that disproportionately affects elderly and hospitalised patients worldwide.

View original technical description
This project includes work on manufacture of highly potent antibodies against Clostridioides difficile toxins TcdA and TcdB in sheep and their formulation as an oral suspension (named OraCAb) for treatment of mild, moderate and severe C. difficile infection (CDI). The work on the project will be directed by MicroPharm and will include a major contribution from the University of Nairobi, Kenya, and Fiona Stanley Hospital, Australia where the clinical trial of OraCAb will be carried out by teams experienced in clinical trials and CDI research. The clinical study in Kenya will be managed by a Principle Investigator based in the University of Texas Health Science Center at Houston, USA. The aim of this project is to determine the safety and clinical response of MicroPharm’s therapeutic antibodies against TcdA /TcdB, formulated in a protective formulation that should ensure their integrity while passing through the gastrointestinal (GI) tract and designed for the treatment of patients with mild, moderate and severe CDI. This will be completed by achieving the following major deliverables: 1.To raise highly potent antibodies against TcdA /TcdB in sheep. 2.Manufacture of OraCAb. 3.To obtain authorisation for and carry out the clinical study in patients with mild, moderate and severe CDI.

View the original record at the funder ↗

Researchers

John Landon (EPMC Awardee)Rossen Donev (EPMC Awardee)

Related Research

Grants with similar aims, by meaning.

Preclinical development and assessment of an oral therapeutic for Clostridium difficile infection
Biomedical Catalyst – Use of Ovine Polyclonal Antibodies to Treat Severe Clostridium difficile Infections
Use of Ovine Polyclonal Antibodies to Treat Severe Clostridium difficile Infections
Uncovering the molecular epidemiology of Clostridioides difficile in Africa to guide treatment and inform vaccine efficacy
Phase IIa Clinical Trial for a Novel Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)

Original classification

Discretionary Award

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.