CAMBRIDGE, UK, Sept. 27, 2018 (GLOBE NEWSWIRE) -- Oral Alicaforsen Appears Safe and Well-Tolerated
via NEWMEDIAWIRE – Atlantic Healthcare plc (“Atlantic Healthcare” or “Company”), a specialist pharmaceutical company focused on developing and commercializing gastrointestinal therapeutics, announces that its Phase 1 trial of an oral alicaforsen tablet for Crohn’s disease found that the formulation appears to be safe and well-tolerated.
The trial was designed to evaluate safety and tolerability and confirm the site of release of the oral alicaforsen tablet, for delivery to the small intestine, where Crohn’s disease is most prevalent. A total of 15 healthy male volunteers received 240mg alicaforsen in oral tablet form on two separate occasions, once with food and once fasted.
The results demonstrated that the oral tablet appeared to deliver product safely, with all tablets disintegrating to release product before the end of the small intestine. In addition, in line with expectations, the trial showed minimal systemic absorption following oral administration, which is desirable for targeted topical activity within the gut.
Atlantic Healthcare will now start planning for a Phase 2b efficacy trial of alicaforsen tablet in Crohn’s.
Toby Wilson Waterworth, CEO, Atlantic Healthcare commented: “We are delighted to have shown that alicaforsen appears to be delivered safely to the small intestine in oral tablet form, and that it is well tolerated. When viewed alongside results from other alicaforsen clinical trials in ulcerative colitis, the minimal systemic absorption reinforces the drug’s potential as a topical product for Inflammatory Bowel Disease, whether administered orally or rectally.”
Alicaforsen has the potential to create a new class of treatment for Inflammatory Bowel Disease (IBD) and other inflammatory diseases. Atlantic Healthcare’s lead program, Camligo™ (alicaforsen) enema for the treatment of pouchitis, is in a Phase 3 trial, with results expected in Q1 2019.
For more information about Atlantic Healthcare and the alicaforsen pipeline, please go to www.atlantichc.com/alicaforsen
About Atlantic Healthcare plc (www.atlantichc.com)
“Atlantic Healthcare” is a specialist pharmaceutical company focused on developing and commercializing gastrointestinal therapeutics, which address unmet patient needs and rare diseases. The Company owns the exclusive worldwide rights to alicaforsen, a promising new drug for the treatment of inflammation. Its most advanced development program – Camligo™ (alicaforsen) enema - is undergoing a pivotal Phase 3 trial for pouchitis. In addition, work is ongoing to develop and deepen the pipeline for alicaforsen with treatments for Crohn’s disease, ulcerative colitis and other gastrointestinal (GI) indications.
Atlantic Healthcare has a highly committed investor base and is led by an experienced international Board and Leadership Team, with deep roots and a proven track record in the pharmaceutical industry. Fundraising to date includes £1.9m through SBRI funding awarded by Innovate UK, the UK Government's innovation agency (www.innovateuk.gov.uk). In Q1 2016 the Company closed a $24m round led by LDC (the private equity division of Lloyd's Banking Group) with new and existing investors.
Crohn’s disease
Crohn’s Disease is an inflammatory disease which can affect any part of the digestive system, from the mouth to the anus. However, it most commonly occurs in the last section of the small intestine (ileum). Common symptoms can include diarrhea, abdominal pain and the presence of blood and mucus in the stool. Over time, inflammation can damage sections of the GI tract, resulting in complications which usually require surgery to remove the diseased tissue.
In 2016, there were estimated to be 1.3m patients diagnosed with Crohn’s in the U.S. and European markets (Source: Decision Resources).
About Alicaforsen
Alicaforsen is a novel antisense drug. It is a pipeline in a drug, with the potential to establish a new class of therapy for the treatment of multiple inflammatory gastrointestinal disorders.
For more information about alicaforsen and how it works, please go to: www.atlantichc.com/alicaforsen
For published papers please go to: www.atlantichc.com/published-papers
Forward Looking Statements
This press release contains forward-looking statements including, without limitation, the information provided regarding future Phase 2b efficacy trials, the potential use of alicaforsen as a topical product for Inflammatory Bowel Disease (“IBD”), the potential to create a new class of treatment and use for IBD and other inflammatory diseases, and the expectation of obtaining Phase 3 results in 2019 for Camligo™ (alicaforsen). While Atlantic Healthcare believes the 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, including, among others, that the development of alicaforsen for the 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 as new information becomes available.