ViroPharma has initiated dosing in the phase 1 clinical trial for NTCD (non-toxigenic Clostridium difficile), a novel treatment approach for preventing recurrent Clostridium difficile infections (CDI).
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.
Reportedly, the company plans to initiate NTCD repeat dosing in older adults following exposure to oral antibiotics. 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.
Colin Broom, chief scientific officer at ViroPharma, said: Colonization of the large bowel with non-toxin producing strains of C. difficile is known to prevent the development of symptomatic CDI.
We have the opportunity with NTCD to develop this preventative therapy to significantly reduce the incidence of recurrent disease for patients with CDI. The ultimate goal is to colonize patients with this particular strain of non-toxin producing C. difficile thereby protecting patients until normal GI flora returns, she added.