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

Smad7 Antisense Oligonucleotide-Based Therapy in Crohn's Disease: Is it Time to Re-Evaluate? (PubMed, Mol Diagn Ther) - "We illustrate the recent data indicating that the various batches of mongersen, used during the phase III program, are chemically different, with some of them being unable to downregulate Smad7 expression. Overall, these findings suggest the necessity of new clinical studies to further evaluate the efficacy of chemically homogenous batches of mongersen in patients with inflammatory bowel diseases (IBDs), and, at the same time, they can help understand the failure of other clinical trials with antisense oligonucleotides in IBD (i.e. alicaforsen)."

Clinical • Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Oncology • SMAD7 • TNFA

Atlantic Healthcare completes patient enrollment to its Phase 3 study of alicaforsen to treat IBD pouchitis (GlobeNewswire) - “Atlantic Healthcare plc…announced that it has completed enrollment in its Phase 3 study of alicaforsen in patients with IBD pouchitis….Atlantic Healthcare expects to complete the Phase 3 study and report preliminary results Q1 2019.”

Enrollment closed • P3 data: top line • Inflammatory Bowel Disease

Atlantic Healthcare hosts key opinion leader discussion on unmet medical need in ulcerative colitis and the advantages of Alicaforsen (GlobeNewswire) - " 'Alicaforsen meets this criterion having clearly demonstrated its safety in the clinic. Further study is now merited to confirm the promising efficacy profile observed in Phase 2 studies.'...Toby Wilson Waterworth, CEO, Atlantic Healthcare plc said: 'This is an exciting time for Atlantic Healthcare as we prepare for the Phase 3 trial of alicaforsen enema in ulcerative colitis (UC)...Targeting multiple patient groups, Atlantic Healthcare is also developing tablet formulations of alicaforsen for initiation of Phase 2b studies in UC and Crohn’s.' "

New P2b trial • New P3 trial • Pipeline update

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

Atlantic Healthcare’s inflammatory bowel disease RNA drug fails phase III (Labiotech.eu) - P3, N=138; "...the drug failed to meet the primary endpoints of the trial, which were achieving remission and reducing the patient’s toilet trips. However, the company reported that certain groups of patients may have benefitted more than others, and, bearing this in mind, will discuss the regulatory approval options with the FDA."

P3 data