Pouchitis

Pouchitis is an inflammatory disease of the pouch. It is a serious and rare form of IBD with no approved therapy and limited treatment options.

Like ulcerative colitis, pouchitis is a progressive disease characterised by inflammation, ulceration, increasingly uncontrolled, frequent and urgent emptying of the bowel (up to 10-20 times a day and night), with a corresponding reduction in quality of life.

Unfortunately, while 50% of patients with a pouch have a good prognosis, the remaining patients suffer a recurrence of disease which is similar in many respects to their previous condition of ulcerative colitis. Recurrence of disease in the pouch is described as “pouchitis”. We estimate there to be 110,000 patients in the US and 86,000 patients in the EU being treated for pouchitis.

Unmet medical need in pouchitis

There are no products approved for pouchitis, so treatment is confined to off-label therapies, involving a step-by-step ‘try and see’ approach, with limited effectiveness.

Most clinicians will begin therapy for pouchitis with antibiotics, such as ciprofloxacin, metronidazole and rifaximin.

​These drugs may be administered either as single agents, or in combination. For some patients, antibiotics will be effective in the short-term.

However, many patients become antibiotic refractory (no longer respond to treatment), or antibiotic dependent (demonstrating a limited but unsatisfactory response to treatment, despite long term use). In addition to limited effectiveness, antibiotic use can be associated with significant risks, notably neuropathy, tendonitis and c. difficile associated diarrhoea.

Alternatives to antibiotics

The failure of patients to adequately respond to antibiotics is extremely problematic in the context of pouchitis management.

All potential off-label treatments will have been considered in the ulcerative colitis setting where, by definition, they have failed to be effective, resulting in surgery to create the pouch.

The patient is therefore left with the dilemma that the therapies available may not be effective.

It is recognised that there is a significant need for new, safe and effective treatments for pouchitis which are convenient to self-administer and which can provide a durable response. Camligo™(alicaforsen enema) has the potential to address these needs.

200,000

patients in the U.S. and Europe