Atlantic Healthcare completes patient enrollment to its Phase 3 study of alicaforsen to treat IBD Pouchitis

Study completion and top-line data expected in Q1 2019

CAMBRIDGE, UK I May 02, 2018 I Atlantic Healthcare plc (Atlantic Healthcare), an emerging trans-Atlantic pharmaceutical company with a core focus on gastrointestinal (GI) disorders, today announced that it has completed enrollment in its Phase 3 study of alicaforsen in patients with IBD pouchitis, a rare and serious form of inflammatory bowel disease (IBD) for which there is no approved therapy and limited treatment options.

Prof. Brian Feagan, Senior Scientific Director at Robarts Clinical Trials Inc., and Chief Investigator on the study said: “I am pleased to see completion of enrollment of patients to this Phase 3 study providing the potential for the first and only approved treatment for pouchitis. This is another important milestone in assessing the clinical value of alicaforsen in this setting, a rare disease believed to impact the lives of approximately 200,000 patients in the U.S. and Europe, for which there remains a critical unmet clinical need.”

The Phase 3 randomised, double-blind, placebo-controlled study is designed to assess the safety and efficacy of alicaforsen, as an enema formulation, in patients with pouchitis in active flare who have failed to adequately respond to a course of antibiotics, or who are contraindicated for antibiotics.

The study involves patients who had previously undergone colectomy to remove the colon due to failure of drug therapy options for ulcerative colitis (UC), and have then undergone ileal pouch-anal anastomosis (IPAA) surgery to create a new rectum. Patients enrolled at 40 trial centres across the U.S., Canada, Europe and Israel were randomised one-to-one to receive 240mg alicaforsen enema or placebo, self-administered daily for 6 weeks. The co-primary endpoints of the study are improvement in endoscopic healing and reduction in bowel frequency at week 10. Secondary endpoints include improvement in other symptoms of the disease and quality of life. Patients are monitored for up to 6 months following treatment. 

Toby Wilson Waterworth, CEO at Atlantic Healthcare said: “We are pleased to have achieved this important milestone in our alicaforsen clinical development strategy and value creation for shareholders, and look forward to sharing preliminary results of the study early next year. We extend our gratitude to the patients who have participated in this study and to the clinical investigators and patient advocacy groups who share our commitment to improving the care and outcomes of patients with GI disorders. I would also like to acknowledge the commitment and dedication of my colleagues at Atlantic Healthcare and to thank our investors for their continued support. We believe that alicaforsen has tremendous potential for improving the care and quality of lives of patients with pouchitis, and potentially other serious inflammatory GI conditions.” 

Atlantic Healthcare expects to complete the Phase 3 study and report preliminary results Q1 2019. A rolling submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for alicaforsen in the treatment of pouchitis was initiated in May 2017. Alicaforsen has also been granted Orphan Drug status by the FDA and the European Medicines Agency (EMA), and received FDA Fast-Track designation in this indication.

About Atlantic Healthcare plc (www.atlantichc.com)

“Atlantic Healthcare” is an emerging trans-Atlantic pharmaceutical company with a core focus on gastrointestinal (GI) disorders including Inflammatory Bowel Disease (IBD). The Company’s lead product, alicaforsen enema, is in a pivotal Phase 3 study for pouchitis, and in preparation for Phase 3 clinical development in ulcerative colitis (UC). The Company is also developing two tablet formulations of alicaforsen, to treat Crohn's disease and UC. Atlantic Healthcare has a highly committed investor base, and an experienced international leadership team. Atlantic Healthcare's fundraising to date includes £1.9m through SBRI funding awarded by Innovate UK, the UK Government's innovation agency (www.innovateuk.gov.uk). In Q1 2016 the Company closed a $24m round led by LDC (the private equity division of Lloyd's Banking Group) with new and existing investors.

About Pouchitis

Patients who have failed drug treatment options for ulcerative colitis often progress to having their diseased colon being removed, a new rectum created and the bowel reconnected with a procedure called pouch surgery (ileal pouch-anal anastomosis – IPAA). Surgeons use the end of the small intestine (ileum) to create a pouch to act as a new rectum, typically shaped like the letter J. The pouch is attached internally to the area just above the anus to hold faeces before being evacuated.

Pouchitis is the return of inflammatory disease in the pouch. It occurs in approximately half of the people who have the IPAA procedure. Signs and symptoms of pouchitis can include inflammation and ulceration, diarrhoea, abdominal pain, cramps, fever, an increased number of bowel movements, night-time faecal seepage, faecal incontinence, and a strong urge to have a bowel movement.

About Alicaforsen

Alicaforsen is being developed 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.

Alicaforsen is currently in development for the treatment of IBD. An enema formulation is currently in a pivotal Phase 3 study agreed with U.S., Canadian and European regulatory agencies in patients with active pouchitis. The study has completed enrollment of patients to approximately 40 trial centres across the U.S., Canada, Europe, and Israel, and is expected to report preliminary data in Q1 2019.

There is currently no approved treatment for pouchitis in the U.S. or Europe and there are limited treatment options for UC and Crohn’s disease. 

Under a rolling submission agreement with the FDA, Atlantic Healthcare has filed the nonclinical data package of its New Drug Application (NDA) for alicaforsen to treat pouchitis with the regulator. Alicaforsen has also been granted FDA Fast-Track designation, plus U.S. and European Orphan Drug designations for this indication. 

​Alicaforsen enema has shown, in five Phase 2 clinical studies involving 377 patients with UC and pouchitis, to reduce inflammation and promote mucosal healing with good tolerability and a durable effect. Alicaforsen also has a good safety profile based on data from more than 1,000 patients (enema, parenteral, and IV delivery). 

Alicaforsen is an antisense oligonucleotide, which has been designed to interact and down regulate mRNA for ICAM-1, a well-recognised cell-surface protein that is involved in the inflammatory response of both the adaptive and innate components of the immune system, and is over-expressed in patients with IBD.1 Research at Atlantic Healthcare has also provided evidence that alicaforsen can interact with TLR-9, an intracellular receptor involved in TLR-9 signaling pathways that activate cells of the innate immune system involved in inflammatory responses.2

Atlantic Healthcare has supplied more than 300 courses of alicaforsen enema to patients in Europe through unsolicited requests via Named Patient Supply regulations. This has provided further evidence of efficacy and safety in the pouchitis3 and UC indications.4-6

References:

  1. Inflammatory Bowel Disease. Imre Szabo. ISBN 978-953-51-0879-5
  2. Toll-like receptors: the swiss army knife of immunity and vaccine development Jennifer K Dowling and Ashley Mansell. Clinical & Translational Immunology (2016) 5, e85; doi:10.1038/cti.2016.22
  3. 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
  4. Alicaforsen Retention Enema Induces Long-Term Remission in Patients with Ulcerative Colitis. Zaid Heetun, David Gibson, Denise Keegan, Kathryn Byrne, Hugh E Mulcahy, Garret Cullen, Glen A Doherty. Irish Soc Gastroenterol Nov 2014
  5. Alicaforsen, ICAM-1 enema as a treatment option when treating distal ulcerative colitis. LA. Bark 1 , I. Löfberg 1 , B. Håkansson 1 , U. Sjöqvist 1 (www.atlantichc.com/la-bark-abstract-pdf)
  6. Alicaforsen, an antisense inhibitor of Intercellular Adhesion Molecule-1, in the treatment for left-sided ulcerative colitis and ulcerative proctitis. Thomas Greuter, Stephan Vavricka, Luc Biedermann, Julia Pilz, Jan Borovicka, Frank Seibold, Bernard Sauter, Gerhard Rogler. Dig Dis (2017) DOI: 10.1159/000484979

SOURCE: Atlantic Healthcare

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