• COVID-19 virus highlights medical need to move beyond immunosuppression therapy for patients with Inflammatory Bowel Disease (IBD)
• Leading clinicians call for new safe and effective therapies for moderate to severe IBD
• Atlantic Healthcare’s alicaforsen, in late stage development for moderate to severe IBD, has the potential to provide a step change in therapy

Cambridge, UK; June 30, 2020. The global Covid-19 virus pandemic has heightened the awareness around the use of immuno-suppressive therapies in moderate to severe IBD, and the increased potential of infections and other complications arising in immuno-suppressed patients(1). As such, there is a need for new therapies that provide a step change in safety and efficacy.

Atlantic Healthcare plc (“Atlantic Healthcare” or “Company”) is progressing alicaforsen for moderate to severe IBD. It is preparing for a Phase 3 study with an enema formulation for ulcerative colitis and preparing for two Phase 2b studies, of separate oral tablet formulations, for the treatment of ulcerative colitis and Crohn’s disease. Alicaforsen is delivered as a locally acting, topical therapy, which has been shown to be safe in studies involving more than 1,000 patients, with minimal systemic exposure, and providing a durable response.

Brian Feagan, MD, FRCPC, an acknowledged global expert in IBD and Director at Alimentiv, formally Robarts Research Institute said: “There is lots of room for improvement, and opportunity for new therapies in moderate to severe IBD.”

“Improved safety should now be a minimum requirement for new market entrants in the context of evolving from existing, non-specific, systemic, immunosuppressive therapies, to the next generation of treatment.”

“Alicaforsen has differentiated characteristics which provide the potential for a step change in treatment to address these needs.”

A forthcoming paper in Clinical Gastroenterology and Hepatology(2), highlights the issues and challenges around the use of immuno-suppressive therapy, which have been brought into focus by COVID-19: “COVID-19 has been of particular interest to our patients on immunosuppressive agents (immunomodulators or biologics) such as those with inflammatory bowel disease (IBD).”

“There are currently no specific recommendations [around COVID-19] for people on immunosuppression therapy.

Prior IBD research has found that viral infections are more likely among patients on immunomodulators.”

Prior research in the journal, Inflammatory Bowel Disease, discusses the medical quandary in managing Herpes Zoster infections in IBD patients(1). “Herpes zoster (HZ) is an opportunistic viral reactivation often observed in IBD patients.”

“Immunosuppressive medications used to treat IBD, increase patients’ susceptibility to opportunistic infections.”

Furthermore, authors in United European Gastroenterology Journal cite an increased susceptibility to other viruses, including Cytomegalovirus and Epstein-Barr virus, claiming an approximate 3-fold increase in vulnerability as a result of immuno-suppressive therapy(3).

About Atlantic Healthcare
Atlantic Healthcare plc (“Atlantic Healthcare” or “Company”), is a specialist pharmaceutical company focused on acquiring, developing and commercializing therapeutics that address unmet patient needs and rare diseases, with a focus on gastroenterology.

The Company owns the exclusive worldwide rights to alicaforsen, a novel antisense drug in development for ulcerative colitis and Crohn’s disease. In 2019, it also acquired the global rights to renzapride, which has the potential to address the unmet needs of multiple orphan disease patient groups suffering gastrointestinal motility disorders.

In due course 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, including the Middle East.

The Company is led by an experienced international Board and Leadership Team, with deep roots and a proven track record in the pharmaceutical industry.

Forward Looking Statements

While Atlantic Healthcare believes any forward-looking statements in this press release are accurate, the statements represent Atlantic Healthcare’s beliefs only as of the date of this press release. A number of factors could cause actual events or results to differ materially from those indicated by such statements. These forward-looking statements involve risks and uncertainties. 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 a 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 as new information becomes available.

References:

1. https://www.ncbi.nlm.nih.gov/pubmed/27598743
2. https://www.cghjournal.org/article/S1542-3565(20)30330-X/pdf
3. https://journals.sagepub.com/doi/pdf/10.1177/2050640619889763

For more information please contact:
Atlantic Healthcare
Adam Michael (Head of Communications)
+44 1799 512 055
+44 777 588 1813
[email protected]