On 29 June 2018, clinicians from St Mark’s Hospital in London will host The St Mark’s Pouch Masterclass, celebrating the 40th anniversary year of the first IPAA surgery at the hospital.

Back in 1978 Sir Alan Parks at St. Mark’s Hospital published the outcomes of pioneering new surgery in a series of 5 ulcerative colitis patients. Colectomy with the formation of a stoma was an option. Alternatively, however, having removed the colon, Parks used the end of the small intestine (ileum) to create a pouch attached the anus to form a new artificial rectum; and the first ileal pouch-anal anastomosis (IPAA), or J-Pouch, was created. Since then the procedure has been widely adopted and is now considered the gold-standard surgical approach in this patient group.

IPAA is a successful surgical procedure, with many patients gaining long-term benefit. However, a significant number of patients experience recurrent disease, in the form of pouchitis. The incidence of pouchitis is 20% within one year of IPAA surgery, increasing to 40% of patients after five years, and around 50% of patients after ten. While pouchitis remains a rare disease, it affects some 200,000 people worldwide.

There is currently no known cure for pouchitis and there is no approved treatment. Treatment is via therapies used to treat other forms of IBD, involving a step by step “try and see” approach, often with limited effectiveness. Most physicians begin therapy with antibiotics, frequently ciprofloxacin and metronidazole, which are ideally only prescribed for short-term use, as antibiotics can have long-term safety issues (including neuropathy, tendonitis and C. difficile infection). Additionally, patients can become unresponsive (refractory) to antibiotics over time and then alternative therapeutic approaches are required.

Beyond antibiotics there are a number of other drugs used to treat pouchitis, and their use depends on disease severity. Physicians may use steroids, such as budesonide, immunosuppressant agents and anti-inflammatory biologics. These therapies may be delivered through various routes, including enemas inserted directly into the pouch through the anus, tablets or liquids taken by mouth, and some drugs are given by injection or infusion. Probiotic therapies have also shown some efficacy in clinical trials when used as prophylactic agents to maintain patients in remission.

St Mark’s has remained a world-leading centre of excellence for the research and treatment of pouchitis. A team, led by St Mark’s, published a paper describing the treatment options for pouchitis in 2016.

Atlantic Pharmaceuticals is developing alicaforsen as a locally active, topical treatment with the potential to establish a new class of therapy, with clear differentiating features, for the treatment of multiple inflammatory GI disorders. Our lead programme with alicaforsen enema, in a pivotal Phase 3 study for pouchitis in patients that have failed to respond adequately to antibiotics recently completed recruitment; St. Mark’s was one of 40 international investigator centres.

The Company expects to announce headline data on the study in H1 2019. If this builds on earlier data showing both safety and efficacy, Atlantic Pharmaceuticals will complete its rolling submission with the U.S. Food and Drug Administration, and also seek marketing approval with the European Medicines Agency and other international regulatory bodies. If successful, the Company looks forward to integrating alicaforsen into the matrix of therapies to treat pouchitis. In the meantime, Atlantic Pharmaceuticals welcomes the opportunity to sponsor the St Mark’s Pouch Masterclass, hear from clinicians, and celebrate the progressive work by the team over the last 40 years.

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