About Crohn’s Disease
Crohn’s disease (CD) is a form of inflammatory bowel disease (IBD), which affects up to 1 million people in the US. It occurs throughout the digestive tract but appears more frequently in the small intestine and is characterised by flares of inflammation requiring episodic escalation of medication or surgery. Crohn’s disease is underpinned by a fluctuating and unstable gut microbiome (Halfvarson et al., 2017 Nat Microbiol).
Paediatric CD (pCD) is relatively rare but as well as suffering from typical CD symptoms, pCD patients also experience inhibited growth through malnutrition, pubertal delay and bone demineralisation. There is a strong need for safer, more tolerable and more effective products to treat this disease because current approaches can be problematic for children exacerbating growth retardation.
Thetanix has a targeted anti-inflammatory mechanism and acts by inhibiting the activation of transcription factor NF-κB, an important intracellular mediator of inflammation. In targeting NF-κB, Thetanix acts on the same pathway as, and directly upstream of, a number of blockbuster biologics already approved in Crohn’s disease.
Thetanix is being developed as an oral maintenance therapy for adults and children with Crohn’s disease. There is an unmet need for safe and effective long-term maintenance therapies in CD, particularly in the mild-to-moderate population.
We have completed a Phase Ib clinical study to assess the safety and tolerability of Thetanix in 18 paediatric patients with Crohn’s disease. We expect to announce the results of this study later in 2018. We are currently planning a Phase II study in adults with Crohn’s disease, for which we anticipate to make regulatory filings by the end of 2018.