The patent (No. 9453221) extends the use of alicaforsen in IBD-related rectal stump inflammation and pain, and is part of the trans-Atlantic group’s strategy to broaden the clinical indications and formulations based on alicaforsen.
The therapy candidate is being evaluated in a Phase 3 clinical trial for the treatment of IBD pouchitis, a nonspecific inflammatory condition in the ileal pouch reservoir (an artificial rectum surgically created out of ileal gut tissue in patients who have undergone a colectomy) for patients with ulcerative colitis (UC). There are currently no approved therapies for the condition.
The placebo-controlled Phase 3 trial (NCT02525523) is evaluating the effectiveness and safety of alicaforsen in a topical formulation in up to 138 patients with IBD pounchitis. All participants are being treated with either with 240 mg of alicaforsen or a placebo, self-administered daily for six weeks. The trial is currently recruiting patients.
The trial’s primary endpoints include the number of patients with endoscopic remission and the number of patients with a reduction in relative stool frequency after 10 weeks. At the start of study and at weeks 6 and 10, all patients will undergo endoscopy examination and will have biopsy samples taken.
Study participants will be monitored for up to six months or until they experience a flare. Patients’ quality of life is also being evaluated.
The trial is being conducted at 40 centers in the United States, Canada, Europe, and Israel, with results expected in the second half of 2017.
“This latest granted patent extends the family of intellectual property protection covering Atlantic Healthcare’s product, alicaforsen, for the treatment of multiple indications within inflammatory bowel disease (IBD),” Toby Wilson Waterworth, CEO of Atlantic Healthcare, said in a recent press release. “The IP protection, which includes the use of alicaforsen in ulcerative colitis and pouchitis, provides protection for alicaforsen out to 2030 and beyond.”
Atlantic Healthcare is based in Cambridge, England, and Raleigh, North Carolina.
“As with other forms of IBD, existing therapies to treat pain and inflammation in a rectal stump have limited efficacy, with patients often becoming resistant to treatment,” Waterworth said. “With no approved therapy there is a clear unmet clinical need, which alicaforsen has the potential to address as a first-in-class drug, harnessing an alternative mode of action.”
Alicaforsen is a highly selective ICAM-1 inhibitor that down-regulates ICAM-1 mRNA, the messenger RNA responsible for the development and expression of ICAM-1 on the cell surface. ICAM-1 plays a very important role in the inflammatory process associated with UC and pouchitis. Alicaforsen aims to block the mechanism for local inflammation in the colon when treating ulcerative colitis and pouchitis.
In Phase 2 trials, alicaforsen was shown to be effective in providing a durable response lasting in patients with flare of an average of six months following a six-week course of once-daily treatment.
Atlantic Healthcare has global rights to alicaforsen, which has been licensed from Ionis Pharmaceuticals.