Leadership Team available for meetings in San Diego, April 30 – May 3

Cambridge, UK; April 20, 2017. Atlantic Healthcare plc (“Atlantic Healthcare”), an emerging trans-Atlantic pharmaceutical company with a core focus on gastrointestinal (GI) disorders, announces that its Director of International Operations, Dr. Janette Thomas, and VP Manufacturing, Dr. Mike Webb, will be presenting and attending TIDES: Oligonucleotide and Peptide Therapeutics, San Diego.

Atlantic Healthcare will be presenting on Wednesday 3 at 15.15.

For more information please contact:

Atlantic Healthcare

Janette Thomas (Director of International Operations)

+44 1799 512 055

Adam Michael (Head of Communications)

+44 1799 512 055
+44 777 588 1813

adam.michael@atlantichc.com

 

Notes to Editors:

About Atlantic Healthcare plc (www.atlantichc.com)

“Atlantic Healthcare” or “the Group” is an emerging trans-Atlantic pharmaceutical company with a core focus on gastrointestinal disorders including Inflammatory Bowel Disease (IBD). The Group’s lead product is alicaforsen enema, in a pivotal Phase 3 trial for pouchitis, and in preparation for Phase 3 clinical development in ulcerative colitis (UC). Alicaforsen is also generating early repeat revenues in Europe through unsolicited requests via the Named Patient Supply protocols. The Group has FDA and EMA orphan drug designations, and FDA Fast-Track designation, in pouchitis. Atlantic Healthcare has a highly committed investor base, and an experienced international leadership team. Atlantic Healthcare’s fundraising to date includes £1.9m through SBRI funding with Innovate UK, the UK Government’s innovation agency (www.innovateuk.gov.uk). In 1Q 2016 the Group closed a $24m round led by LDC (the private equity division of Lloyd’s Banking Group), with investment from founders of both Salix Pharmaceuticals and Clinigen Group, and existing shareholders.

About Alicaforsen

Alicaforsen is being developed as a locally active, topical formulation with the potential to establish a new class of therapy, with clear differentiating features, for the treatment of inflammatory bowel disease (IBD). Atlantic Healthcare has received agreement from FDA to initiate a rolling submission of its New Drug Application (NDA) for alicaforsen to treat pouchitis.

Alicaforsen enema is currently in a Phase 3 trial agreed with U.S., Canadian and European regulatory agencies in patients with active, chronic pouchitis. The trial is recruiting 138 patients to approximately 40 trial centres across the U.S., Canada, Europe, and Israel. Alicaforsen enema is in preparation to commence a pivotal Phase 3 for active distal ulcerative colitis (UC). There is currently no approved treatment for pouchitis in the U.S. or Europe and there are limited treatment options for UC.

Alicaforsen has shown, in five Phase 2 clinical studies involving 377 patients, to reduce inflammation and promote mucosal healing with good tolerability and a durable effect. Alicaforsen also has a good safety profile based on data from more than 1,000 patients.

Alicaforsen is an antisense oligonucleotide which has been designed to interact with mRNA for ICAM-1, a well-recognised cell-surface protein that is involved in the inflammatory response of both the adaptive and innate components of the immune system, and is over-expressed in patients with IBD[5]. Research at Atlantic Healthcare has also provided evidence that alicaforsen can interact with TLR-9, an intracellular receptor involved in TLR-9 signalling pathways that activate cells of the innate immune system, and are involved in inflammatory responses[2].

As noted above, alicaforsen in pouchitis has been granted FDA Fast-Track designation, plus U.S. and European Orphan Drug designations. Alicaforsen is generating early repeat revenues in Europe through unsolicited requests via the Named Patient Supply protocols. This has demonstrated further evidence of efficacy and safety in the pouchitis[1] and UC indications[3,4].

References:
Alicaforsen, an antisense inhibitor of ICAM-1, as treatment for chronic refractory pouchitis after proctocolectomy: A case series. Thomas Greuter, Luc Biedermann, Gerhard Rogler, Bernhard Sauter and Frank Seibold. UEG Journal (2015) DOI: 10.1177/2050640615593681
Toll-like receptors: the swiss army knife of immunity and vaccine development Jennifer K Dowling and Ashley Mansell. Clinical & Translational Immunology (2016) 5, e85; doi:10.1038/cti.2016.22

Alicaforsen Retention Enema Induces Long-Term Remission in Patients with Ulcerative Colitis. Zaid Heetun, David Gibson, Denise Keegan, Kathryn Byrne, Hugh E Mulcahy, Garret Cullen, Glen A Doherty. Irish Soc Gastroenterol Nov 2014

Alicaforsen, ICAM-1 enema as a treatment option when treating distal ulcerative colitis . LA. Bark 1 , I. Löfberg 1 , B. Håkansson 1 , U. Sjöqvist 1 (www.atlantichc.com/la-bark-abstract-pdf)
Inflammatory Bowel Disease. Imre Szabo. ISBN 978-953-51-0879-