CAMBRIDGE, United Kingdom, July 31, 2019 /PRNewswire-PRWeb/ -- Atlantic Healthcare plc ("Atlantic Healthcare" or "Company"),
In the primary analysis, using an adaptation of the Mayo Score of improvement in endoscopic remission and bowel frequency, the trial did not meet its co-primary endpoints.
However, the data for stool frequency do show an encouraging efficacy signal and remission in 34% of patients. In addition, a re-evaluation of the endoscopy data, using new methods of analysis , indicates a statistically significant endoscopic response was achieved in a number of subgroups of patients.
Toby Wilson Waterworth, Chief Executive, Atlantic Healthcare plc said: "Although we are disappointed that the Phase 3 trial did not achieve statistical significance, we believe the percentage of patients achieving remission in stool frequency and the endoscopic response observed in a number of sub populations of patients could be noteworthy. Having consulted with key opinion leaders and regulatory advisors, we now plan to meet with the U.S. Food and Drug Administration and European Medicines Agency to discuss a pathway to regulatory approval."
He added, "We are grateful to the clinicians and patients who participated in the trial, which confirmed that alicaforsen is safe and well-tolerated, with no drug-related serious adverse events. It is also encouraging to note that the patients who participated in the trial demonstrated strong compliance with alicaforsen enema."
Prof Brian Feagan MD, FRCPC, an acknowledged expert in IBD and Director at Robarts Research Institute added: "It is challenging to develop treatments for orphan-designated diseases. This study makes a significant contribution to the existing body of knowledge in pouchitis. As long as there is no approved treatment, there remains an unmet medical need. It is therefore encouraging to note that alicaforsen enema may benefit some pouchitis patients."
About pouchitis Pouchitis is estimated to impact the lives of approximately 200,000 patients in the U.S. and Europe. It is a progressive disease characterized by inflammation, ulceration and increasingly uncontrolled, frequent and urgent emptying of the bowel (up to 10-20 times a day and night).
Camligo™ (alicaforsen enema) Phase 3 Trial Camligo™ is the brand name of alicaforsen enema to treat orphan-designated pouchitis. The trial was a Phase 3, multi-center, double-blind randomized controlled trial in subjects with chronic antibiotic refractory pouchitis (failed to adequately respond to one or more courses of antibiotics). The trial recruited 138 patients at 40 centers across the U.S., Canada and Europe. Patients received Camligo™ 240mg once daily for six weeks, or placebo. The primary endpoints of the trial were the proportion of patients achieving endoscopic remission and a reduction in stool frequency at week 10. Secondary endpoints assessed improvement in Quality of Life.
1. Saman et al "Reliability among central readers in the evaluation of endoscopic disease activity in pouchitis", American Society for Gastroenterology Endoscopy, Sept 2018
About Atlantic Healthcare Atlantic Healthcare plc is focused on acquiring, developing and commercializing therapeutics that can address unmet needs of patients who are managed by healthcare professionals in hospital and specialist care environments. The Company owns the exclusive worldwide rights to alicaforsen, a novel antisense drug. Recently, it also acquired the global rights to renzapride, which has the potential to address the unmet needs of multiple patient groups with gastrointestinal motility disorders. Atlantic Healthcare intends to commercialize its products in Europe and the U.S. using a specialist sales team targeting healthcare professionals based in hospitals and specialist care centers. The Company plans to partner with established pharmaceutical companies to commercialize its products in the rest of the world. The Company is led by an experienced international Board and Leadership Team, with deep roots and a proven track record in the pharmaceutical industry.
Alicaforsen is an antisense oligonucleotide with the potential to treat multiple patient groups experiencing inflammatory diseases of the GI tract, including ulcerative colitis (UC) and Crohn's Disease. Atlantic Healthcare is developing and deepening the pipeline with plans for a Phase 3 trial of alicaforsen enema for distal colitis and Phase 2b trials in alicaforsen tablet for UC and Crohn's.
For more information about alicaforsen and how it works, please go to: https://www.atlantichc.com/research/alicaforsen/
For published papers please go to: https://www.atlantichc.com/research/publications/
Forward Looking Statements This press release contains forward looking statements that are based on management's beliefs and assumptions as of the date of this press release. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from those indicated by such statements. These forward-looking statements involve risks and uncertainties, including, among others, that the development of any products for their stated uses may not proceed due to safety, efficacy or other reasons. In addition, risks and results in clinical trials may not be indicative of risks or results from later stage or larger scale trials, and there is no assurance of regulatory approval. Existing and prospective investors should not place undue reliance on the forward-looking statements contained in this press release and instead should make their own determinations as to the reliability of such statements. Atlantic Healthcare undertakes no intent or obligation to update the information contained in this press release.
For more information please contact: Atlantic Healthcare Adam Michael +44 1799 512 055 +44 777 588 1813 adam.michael(at)atlantichc.com
U.S. Investor Relations and Media Lazar Partners David Carey / Amy Feldman +1 212-867-1762 atlantic.healthcare(at)lazarpartners.com
European Investor Relations and Media Consilium Strategic Communications Mary-Jane Elliott / Matthew Neal +44 20 3709 5700 atlantichealthcare(at)consilium-comms.com
SOURCE Atlantic Healthcare
Subscribe to our Free Newsletters!