Camligo (alicaforsen rectal) / Ionis, Atlantic Healthcare - LARVOL DELTA

DEVELOPMENT AND VALIDATION OF A NOVEL COMPOSITE INDEX FOR THE ASSESSMENT OF ENDOSCOPIC AND HISTOLOGIC DISEASE ACTIVITY IN POUCHITIS: THE ATLANTIC POUCHITIS INDEX (DDW 2023) - P3 | " Baseline and week 10 pairs of both endoscopic videos and histologic images were obtained from 98 patients with chronic antibiotic-refractory pouchitis who participated in a randomized placebo-controlled trial of alicaforsen enema (ClinicalTrials.gov identifier: NCT02525523)... We developed and internally validated the API, a novel composite index of endoscopic (SES-CD) and histologic disease activity (RHI) that is reliable and significantly more responsive than existing endoscopic pouchitis scoring systems. This promising instrument could be used in clinical trials to evaluate the effectiveness of novel therapies for pouchitis. Further validation is needed in independent datasets."

Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Development and validation of a novel composite index for the assessment of endoscopic and histologic disease activity in pouchitis: The Atlantic pouchitis index. (ECCO-IBD 2023) - P3 | "Methods Paired baseline and week 10 endoscopic videos and histologic images were obtained from 98 patients with chronic antibiotic-refractory pouchitis who participated in a randomised placebo-controlled trial of alicaforsen enema (ClinicalTrials.gov identifier: NCT02525523)...The API is a promising tool for use in clinical trials of novel therapies for pouchitis. Further validation is needed in independent datasets."

Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease

[VIRTUAL] ALICAFORSEN ENEMA IN CHRONIC POUCHITIS: RESULTS OF A PHASE 3 RANDOMIZED, DOUBLE BLIND PLACEBO-CONTROLLED TRIAL (UEGW 2021) - "The study demonstrates the clinical benefit of alicaforsen enema in the treatment of chronic pouchitis as determined by a positive effect on stool frequency and confirms its safety and tolerability. The modified Mayo endoscopy score is inappropriate for patient selection and disease assessment in chronic pouchitis. Statistical efficacy analysis was likely to have been compromised by the 35% discontinuation rate, a result of disallowing antibiotics and rectal budesonide in patients with dependence on these therapies.In view of the possible clinical benefits, robust safety and tolerability of alicaforsen enema; further evaluation is warranted not only in chronic pouchitis but also with priority in distal ulcerative colitis which has better defined measures for patient selection and treatment assessment, notably a clinical correlation between endoscopy scores and symptoms."

Clinical • P3 data • Gastrointestinal Disorder • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • ICAM1

[VIRTUAL] ALICAFORSEN ENEMA IN CHRONIC POUCHITIS: RESULTS OF A PHASE 3 RANDOMIZED, DOUBLE BLIND PLACEBO-CONTROLLED TRIAL (UEGW 2021) - "The study demonstrates the clinical benefit of alicaforsen enema in the treatment of chronic pouchitis as determined by a positive effect on stool frequency and confirms its safety and tolerability. The modified Mayo endoscopy score is inappropriate for patient selection and disease assessment in chronic pouchitis. Statistical efficacy analysis was likely to have been compromised by the 35% discontinuation rate, a result of disallowing antibiotics and rectal budesonide in patients with dependence on these therapies.In view of the possible clinical benefits, robust safety and tolerability of alicaforsen enema; further evaluation is warranted not only in chronic pouchitis but also with priority in distal ulcerative colitis which has better defined measures for patient selection and treatment assessment, notably a clinical correlation between endoscopy scores and symptoms."

Clinical • P3 data • Gastrointestinal Disorder • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • ICAM1

[VIRTUAL] ALICAFORSEN ENEMA IN CHRONIC POUCHITIS: RESULTS OF A PHASE 3 RANDOMIZED, DOUBLE BLIND PLACEBO-CONTROLLED TRIAL (UEGW 2021) - "The study demonstrates the clinical benefit of alicaforsen enema in the treatment of chronic pouchitis as determined by a positive effect on stool frequency and confirms its safety and tolerability. The modified Mayo endoscopy score is inappropriate for patient selection and disease assessment in chronic pouchitis. Statistical efficacy analysis was likely to have been compromised by the 35% discontinuation rate, a result of disallowing antibiotics and rectal budesonide in patients with dependence on these therapies.In view of the possible clinical benefits, robust safety and tolerability of alicaforsen enema; further evaluation is warranted not only in chronic pouchitis but also with priority in distal ulcerative colitis which has better defined measures for patient selection and treatment assessment, notably a clinical correlation between endoscopy scores and symptoms."

Clinical • P3 data • Gastrointestinal Disorder • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • ICAM1

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 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

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