alicaforsen topical (ISIS-2302) / Ionis, Atlantic Healthcare - LARVOL DELTA

Randomized Study of Topical Alicaforsen Enema in Antibiotic Refractory Pouchitis (clinicaltrials.gov) - P3; N=138; Not yet recruiting; Sponsor: Atlantic Pharmaceuticals Ltd

New P3 trial • Biosimilar

Efficacy of Alicaforsen in Pouchitis Patients Who Have Failed to Respond to at Least One Course of Antibiotics (clinicaltrials.gov) - P3; N=138; Recruiting; Sponsor: Atlantic Pharmaceuticals Ltd; Trial primary completion date: Sep 2017 ➔ Jul 2018

Trial primary completion date • Biosimilar • Immunology

Atlantic Healthcare starts pivotal phase 3 trial of alicaforsen to treat inflammatory bowel disease pouchitis (Businesswire) - P3, N=138; NCT02525523; Sponsor: Atlantic Pharmaceuticals Ltd; "Atlantic Healthcare...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...Results are expected to be reported in H2 2017...has regulatory and patent exclusivity until circa 2030."

Anticipated P3 data • Enrollment open • Patent expiry • Inflammatory Bowel Disease

Interfering with leukocyte trafficking in Crohn's disease. (PubMed, Best Pract Res Clin Gastroenterol) - "Targets for modulators of leukocyte trafficking include (examples in brackets) ICAM-1 (alicaforsen, efalizumab); MAdCAM-1 (PF-00547 659); α4 and related receptors (abrilumab, etrolizumab, natalizumab, vedolizumab); chemokine receptor CCR9 (vercirnon); and sphingosine 1-phosphate receptors (etrasimod, fingolimod, ozanimod). Oral and subcutaneous therapies are in development. The safety, efficacy and practice points of licensed drugs are discussed, in addition to initial results from therapeutic trials."

Journal • Review

ISIS 2302-CS27, A 6-Week, Placebo-Controlled Clinical Study to Evaluate the Effectiveness of Alicaforsen (ISIS 2302) in Patients With Mild to Moderate Active Ulcerative Colitis. (clinicaltrials.gov) - P2; N=N/A; Completed; Sponsor: Isis Pharmaceuticals; No longer recruiting ➔ Completed

Clinical • Trial completion

Oligonucleotides-A Novel Promising Therapeutic Option for IBD. (PubMed, Front Pharmacol) - "...Alicaforsen, selectively targets ICAM-1 mRNA...An antisense oligonucleotide against SMAD7 mRNA (mongersen) demonstrated pre-clinical and phase II efficacy in CD, but a phase III clinical trial was stopped due to lack of efficacy...Topical application of cobitolimod was studied in UC patients. We will also discuss two other novel oligonucleotides which act on the GATA3 transcription factor (SB012) and on carbohydrate sulfotransferase 15 (STNM01), which could both represent novel promising therapeutic options for the treatment of UC."

Journal • Review