Clinical Trials

Date: 2018-05-02

Type of information: Completion of patient enrollment

phase: 3

Announcement: completion of patient enrollment

Company: Atlantic Healthcare (UK)

Product: alicaforsen enema

Action mechanism:

  • antisense oligonucleotide. Alicaforsen is an antisense oligonucleotide therapeutic that targets the mRNA for the production of human ICAM-1 protein, a cell-surface adhesion molecule protein over-expressed in IBD patients that is involved in inflammation responses of both the adaptive and innate components of the immune system. It was discovered by Ionis Pharmaceuticals and as of 2017 was under development by Atlantic Healthcare for pouchitis in an enema formulation.
  • In February 2017, Atlantic Healthcare announced that, in addition to targeting ICAM-1, alicaforsen has been shown to target Toll-like receptor 9 (TLR-9). The newly confirmed target, TLR-9, is an intracellular receptor involved in signalling pathways to activate multiple cells within the innate immune system. Iti is a recognised target for the treatment of autoimmune diseases including inflammatory bowel disease (IBD). Atlantic Healthcare has filed patent applications based on alicaforsen targeting TLR-9.
  • Atlantic Healthcare has worldwide exclusive rights to alicaforsen which has been licensed from Ionis Pharmaceuticals, and has regulatory and patent exclusivity until circa 2030.

Disease: pouchitis

Therapeutic area: Inflammatory diseases - Gastrointestinal diseases

Country: Belgium, Canada, France, Ireland, Israel, Italy, The Netherlands, Switzerland, UK, USA

Trial details:

  • 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 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 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 .(NCT02525523)

Latest news:

  • • On May 2, 2018, Atlantic Healthcare  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.
  • 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.
  • 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 FDA for alicaforsen in the treatment of pouchitis was initiated in May 2017.
  • • On February 11, 2016. Atlantic Healthcare announced that patient recruitment has commenced for a Phase 3 trial of 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 Healthcare is recruiting 138 patients at 40 trial centres across the United States, Canada, Europe and Israel.

Is general: Yes