MicroPharm Limited is pleased to announce that it has been awarded funding from Wellcome to undertake a Phase II clinical trial of an oral therapeutic (OraCAb®) for the treatment of non-life-threatening C. difficile (C. diff.) infection (CDI). OraCAb is a polyclonal antibody-based therapeutic, comprising highly potent antibodies targeting C. diff. toxins and formulated to ensure gut activity. OraCAb was developed in collaboration with the United Kingdom Health Security Agency (UKHSA), Porton Down. MicroPharm will be the Sponsor of the multi-country trial with harmonised trial sites across Kenya and Australia to facilitate assessment of globally circulating C. diff. strains. The Kenyan trial will be undertaken in Nairobi and led by clinicians from the University of Nairobi acting in conjunction with the University of Texas Health Science Center, Houston, USA. The Australian trial will be undertaken by clinicians at the Fiona Stanley Hospital, Perth. 

C. diff. infection places huge burden on global health systems, is a driver of drug resistance and is the most common cause of infectious diarrhoea in healthcare settings. It is increasingly recognised as a significant cause of diarrhoea in the general community and a major health burden in many Low-and-Middle-Income Countries (LMIC) for example in Kenya where 25% of all patients with diarrhoea are positive for C. diff. toxic strains. It is estimated that in the United States alone, C. diff. accounts for nearly 700,000 infections and 29,000 deaths annually whilst in the UK, there are around 18,000 CDI cases annually with a case fatality rate of around 14%. An affordable and highly effective antibody therapy that has low or minimal risk of developing antimicrobial resistance and is suitable for use in clinical and outpatient settings globally could have huge patient benefit. 

OraCAb is highly specific in targeting C. diff. toxins TcdA and TcdB and the innovative formulation is designed to maintain OraCAb integrity through the gastrointestinal tract with a view to ensuring activity at the site of C. diff. toxin production. Toxin neutralisation by OraCAb prevents damage to the gut wall and limits disruption to the natural gut flora caused by infection. Importantly, OraCAb offers the potential for global use in neutralising the large variety of 34 different TcdA and TcdB toxinotypes secreted by circulating pathogenic C. diff. strains. 

A successful trial would demonstrate the power of coupling an antibody platform for oral administration to target enteric and diarrhoeal diseases, paving the way for further development towards treating additional unmet medical need in LMICs such as Shigellosis. 

Professor John Landon, (MicroPharm Chairman), commented, “We are grateful for Wellcome’s support for this important project, which we believe will be of profound benefit to patients with this globally recognised cause of morbidity and mortality with devastating effects on health-related quality of life. 

Wellcome Quote: 

“I’m delighted that Wellcome is investing in the clinical development of OraCAb” said Dr Pete Gardner, Research Lead within Wellcome’s Infectious Disease team. “Supporting the acceleration of new interventions to control infectious disease is critical to Wellcome’s mission and new antibody-based medicines offer a much-needed complementary approach to antibiotics in tackling drug resistant bacterial infections. This partnership with MicroPharm for a Phase II clinical trial is especially exciting as it includes sites in Kenya where OraCAb has the potential to be cost-effective, signalling intent that if shown to be safe and efficacious OraCAb could also be accessible to all who may benefit most from it”.