CAMBRIDGE, England--(BUSINESS WIRE)--Atlantic Healthcare plc, an international specialty pharma company focusing on gastrointestinal disorders, is pleased to announce that patient recruitment has commenced for a Phase 3 trial of its wholly-owned product alicaforsen enema to treat Inflammatory Bowel Disease (IBD) pouchitis. There are currently no approved drugs for pouchitis and this trial will be the largest ever conducted for the indication. Atlantic is recruiting 138 patients at 40 trial centres across the United States, Canada, Europe and Israel. Results are expected to be reported in H2 2017.
The trial is a randomised, double-blind, placebo-controlled, pivotal, Phase 3 safety and efficacy study of alicaforsen enema in patients with active, chronic, antibiotic refractory pouchitis. Patients will receive either 240mg alicaforsen enema or placebo, self-administered daily for six weeks. The protocol, including the primary endpoints, is agreed with the FDA, EMA, and Health Canada.
The primary endpoints comprise the proportion of patients with endoscopic remission at week 10, and the proportion of patients with a reduction in relative stool frequency at week 10. Patients will record clinical symptoms associated with pouchitis daily, and will also undergo endoscopic examination of their pouch at the start of the trial and at weeks 6 and 10, with biopsy samples taken where possible. Patients will be monitored for six months or until they next flare, whichever is sooner. The trial will also assess Quality of Life.
“The management of ulcerative colitis and pouchitis continues to be a very important area of concern for gastroenterologists. This will be the most extensive clinical trial ever conducted in pouchitis,” said Prof. Brian Feagan, Director of Clinical Trials at Robarts Research Institute, and Chief Investigator on the trial. “Alicaforsen is potentially one of the most promising new products in the field. Pouchitis is a disease with currently no approved therapies. Existing treatments include antibiotics, steroids and antibody biologics, therapies that these patients will have previously failed in treating their UC, leading those patients to require surgery to remove the colon and form an ileal pouch. As such, alicaforsen has the potential to address an enormous unmet clinical need.”
Commenting on the start of the trial, Toby Wilson Waterworth, CEO of Atlantic Healthcare, said: “Alicaforsen offers patients a potential new alternative and, importantly, this is a new class of therapy. As a local topical treatment, alicaforsen has a highly attractive safety profile and provides the convenience of self-administration at home. In Phase 2 studies alicaforsen was shown to provide patients in flare with a durable response lasting, on average, six months following a once-a-day six-week course of treatment. This trial will assess the efficacy of alicaforsen in pouchitis patients who have failed to respond to first line antibiotic therapies. We plan to report on the trial in H2 2017.”
Atlantic Healthcare has worldwide exclusive rights to alicaforsen which has been licensed from Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) (formerly Isis Pharmaceuticals, Inc.) and has regulatory and patent exclusivity until circa 2030. Alicaforsen is generating early revenues in Europe through Named Patient Supply protocols. This has provided further evidence of efficacy and safety in the pouchitis indication .
1. Alicaforsen, an antisense inhibitor of ICAM-1, as treatment for chronic refractory pouchitis after proctocolectomy: A case series. Thomas Greuter, Luc Biedermann, Gerhard Rogler, Bernhard Sauter and Frank Seibold. UEG Journal (2015) DOI: 10.1177/2050640615593681
Notes to Editors:
About Atlantic Healthcare plc (www.atlantichc.com)
Atlantic Healthcare is an international specialty pharmaceutical company focussed on diseases of the gastrointestinal tract and Inflammatory Bowel Disease (IBD). The Company's lead product is alicaforsen enema, in Phase 3 development for pouchitis, and in preparation for Phase 3 clinical development for Ulcerative Colitis. Alicaforsen is also generating early repeat revenues in Europe through Named Patient Supply protocols. The Company has FDA and EMA orphan designation, and an FDA letter of fast-track in pouchitis. Atlantic Healthcare has a highly committed investor base, and an experienced international management team. Atlantic fundraising to date includes £1.9m through SBRI funding with InnovateUK, the UK Government's innovation agency. (www.inovateuk.gov.uk)
Alicaforsen enema is currently in a Phase 3 trial agreed with U.S., Canadian and European regulatory agencies in patients with active, chronic, antibiotic refractory pouchitis. The trial will recruit 138 patients to 40 trial centres across the U.S., Canada, Europe and Israel. Alicaforsen is an antisense oligonucleotide with a novel mode of action (MOA) for treatment of IBD. Alicaforsen is targeted to ICAM-1, a cell-surface protein which is involved in the inflammatory response and over-expressed in patients with inflammatory disease. Originally developed as an IV formulation for Crohn’s disease, alicaforsen enema is being developed as a locally active topical formulation which has demonstrated, in five Phase 2 clinical studies involving 377 patients, an ability to reduce inflammation and promote mucosal healing with good tolerability and a durable effect. Alicaforsen enema has commenced Phase 3 for pouchitis and is ready to commence Phase 3 for active distal UC. There is currently no approved treatment for pouchitis in the U.S. or Europe and there are limited treatment options for UC. Alicaforsen enema has the potential to establish a new class of therapy with clear differentiating features. Alicaforsen has FDA fast track designation, and FDA orphan drug designation in pouchitis.
Pouchitis is the inflammation of the internal pouch, an artificial rectum created from the terminal ileum (small bowel) in patients with severe Ulcerative Colitis (UC) who have undergone surgery to remove diseased tissue of the colon (colectomy). The procedure is known as Ileal-pouch anal anastomosis (IPAA). Like UC, pouchitis is a progressive disease characterised by inflammation, ulceration, increasingly uncontrolled, frequent and urgent emptying of the bowel (up to 10 or more times a day and night) with a corresponding reduction in quality of life. For pouchitis patients there is a significant unmet medical need and currently no approved treatment in North America or Europe.
Existing treatment is via certain off-label therapies involving a step by step “try and see” approach, often with limited effectiveness. Most physicians begin therapy with antibiotics, only prescribed for short-term use due to long-term safety issues (including neuropathy, tendonitis and potentially fatal C. difficile). Patients can become unresponsive (refractory) to antibiotics over time and require alternative therapeutic approaches.
In the absence of further treatment options, for some patients the only other avenue is surgery to remove the pouch and divert the bowel through the abdominal wall (ileostomy) for collection of the bowel contents using a stoma bag. Infection and other complications can require additional surgeries throughout the patient’s lifetime, to repair and/or relocate the stoma.
There is a significant need for a convenient, effective, localised, topical therapy with a well-tolerated side-effect profile.
– ENDS –