NTCD
According to published literature, approximately 20 to 30 percent of patients suffering from Clostridium difficile infection (CDI) will have at least one episode of relapse of disease. The goal of ViroPharma’s novel NTCD (non-toxigenic C. difficile) program is to prevent such recurrence of disease.
Over the past several years, CDI has increased in severity and incidence. As such, the number of recurrent infections has also increased. According to a recent survey, 55 percent of participating US hospitals reported an increase in the number of treatment relapses over a recent 12 month period (Gelone et al. 2006). Because of this dramatic increase, finding new alternatives to prevent recurrent CDI remains an important medical goal.
Background
ViroPharma acquired NTCD in February 2006 from Dale Gerding, of the Hines VA. The concept behind this novel treatment approach aims to prevent disease recurrence and involves the oral administration of non-toxin producing spores of C. difficile following initial treatment of acute CDI. The underlying concept is to first treat the disease with an effective product like Vancocin (PI) and eradicate the dangerous toxin-producing C. difficile which causes severe CDI. The treated patient could potentially then be dosed with oral NTCD to re-colonize the GI tract and prevent the ‘bad’ bugs from re-infecting the colon until normal GI flora returns and the patient is no longer susceptible to disease.
Status
ViroPharma is conducting a Phase 1 clinical trial for NTCD. The Phase 1 study will determine the safety and tolerability of NTCD dosed orally as single and repeat escalating doses in healthy young (18-45 years of age) and older (60 years of age and older) adults. The study is being conducted in Switzerland. Should the therapy be well tolerated, the company plans to initiate NTCD repeat dosing in older adults following exposure to oral antibiotics. Antibiotic use is associated with disruption of gastrointestinal flora which renders individuals susceptible to C. difficile colonization. The goal of NTCD dosing following antibiotic exposure is to colonize with this non-toxigenic strain of C. difficile and to prevent colonization by toxigenic strains, thereby preventing disease.