Atlantic Healthcare Confirms Alicaforsen Targets TLR-9, Providing A Second Mechanism Of Action To Treat New And Existing Inflammatory Indications
Patent applications filed based on novel discovery, which may provide biological rationale for alicaforsen’s previously observed durable response in inflammatory bowel disease
Cambridge, UK, and Raleigh, NC February 28, 2017. Atlantic Healthcare plc (“Atlantic Healthcare”), an emerging trans-Atlantic pharmaceutical company with a core focus on gastrointestinal (GI) disorders, announces that, in addition to targeting ICAM-1, alicaforsen has been shown to target Toll-like receptor 9 (TLR-9). TLR-9 is a recognised target for the treatment of autoimmune diseases including inflammatory bowel disease (IBD). Alicaforsen is currently being evaluated in a pivotal Phase 3 trial for the treatment of pouchitis, a serious form of IBD for which there are limited treatment options.
Alicaforsen is already known to target ICAM-1[1], a cell-surface adhesion molecule protein over-expressed in IBD patients that is involved in inflammation responses of both the adaptive and innate components of the immune system. The newly confirmed target, TLR-9, is an intracellular receptor involved in signalling pathways to activate multiple cells within the innate immune system[2]. Atlantic Healthcare has filed patent applications based on alicaforsen targeting TLR-9.
Toby Wilson Waterworth, CEO at Atlantic Healthcare said: “This second target of alicaforsen, TLR-9, could have an important impact on the future value of the product. A dual mechanism of action could support Atlantic Healthcare's strategy to broaden the commercial potential of alicaforsen and build a deeper pipeline of applications based on the product. Alicaforsen is initially targeting IBD with potential in multiple inflammatory diseases of the GI tract and elsewhere.”
“Furthermore, the filing of patent applications around the use of alicaforsen to target TLR-9 has the potential to strengthen the Atlantic Healthcare portfolio of intellectual property, which aims to provide global patent protection for the product.”
“I'd like to acknowledge the work of Atlantic Healthcare team members, Dr. Janette Thomas, Director of International Operations, Dr. Lorin Johnson, Non-Executive Director, and Dr. Mike Webb, VP of Manufacturing, whose combined activities resulted in this new research and new patent applications.”
Additionally, the discovery that alicaforsen acts on the TLR-9 signalling pathway may provide a biological rationale for durable responses previously observed in IBD patients receiving alicaforsen. Recent published data, on the use of alicaforsen enema for the treatment of ulcerative colitis and pouchitis, have shown highly durable response rates, with patients experiencing remission times from six to 20 months[1,3,4] following a single once-a-day, six-week course of treatment. In IBD such durable responses are not typically observed from a single course of treatment.
Prof. Brian Feagan, Senior Scientist Robarts Clinical Trials, and Chief Investigator on the alicaforsen pouchitis Phase 3 trial added: “The durable response we are observing [1,3,4] suggests that alicaforsen is acting to modify the biology that gives rise to disease rather than just treating disease symptoms. If further studies demonstrate that alicaforsen can reliably extend remission times, we may have the ability to transform current treatment paradigms and radically improve quality of life for patients living with various types of IBD. Additionally, the discovery of a second target of alicaforsen also has the potential to extend the product's application into many other inflammatory and autoimmune disease areas.”
Cambridge, UK, and Raleigh, NC February 28, 2017. Atlantic Healthcare plc (“Atlantic Healthcare”), an emerging trans-Atlantic pharmaceutical company with a core focus on gastrointestinal (GI) disorders, announces that, in addition to targeting ICAM-1, alicaforsen has been shown to target Toll-like receptor 9 (TLR-9). TLR-9 is a recognised target for the treatment of autoimmune diseases including inflammatory bowel disease (IBD). Alicaforsen is currently being evaluated in a pivotal Phase 3 trial for the treatment of pouchitis, a serious form of IBD for which there are limited treatment options.
Alicaforsen is already known to target ICAM-1[1], a cell-surface adhesion molecule protein over-expressed in IBD patients that is involved in inflammation responses of both the adaptive and innate components of the immune system. The newly confirmed target, TLR-9, is an intracellular receptor involved in signalling pathways to activate multiple cells within the innate immune system[2]. Atlantic Healthcare has filed patent applications based on alicaforsen targeting TLR-9.
Toby Wilson Waterworth, CEO at Atlantic Healthcare said: “This second target of alicaforsen, TLR-9, could have an important impact on the future value of the product. A dual mechanism of action could support Atlantic Healthcare's strategy to broaden the commercial potential of alicaforsen and build a deeper pipeline of applications based on the product. Alicaforsen is initially targeting IBD with potential in multiple inflammatory diseases of the GI tract and elsewhere.”
“Furthermore, the filing of patent applications around the use of alicaforsen to target TLR-9 has the potential to strengthen the Atlantic Healthcare portfolio of intellectual property, which aims to provide global patent protection for the product.”
“I'd like to acknowledge the work of Atlantic Healthcare team members, Dr. Janette Thomas, Director of International Operations, Dr. Lorin Johnson, Non-Executive Director, and Dr. Mike Webb, VP of Manufacturing, whose combined activities resulted in this new research and new patent applications.”
Additionally, the discovery that alicaforsen acts on the TLR-9 signalling pathway may provide a biological rationale for durable responses previously observed in IBD patients receiving alicaforsen. Recent published data, on the use of alicaforsen enema for the treatment of ulcerative colitis and pouchitis, have shown highly durable response rates, with patients experiencing remission times from six to 20 months[1,3,4] following a single once-a-day, six-week course of treatment. In IBD such durable responses are not typically observed from a single course of treatment.
Prof. Brian Feagan, Senior Scientist Robarts Clinical Trials, and Chief Investigator on the alicaforsen pouchitis Phase 3 trial added: “The durable response we are observing [1,3,4] suggests that alicaforsen is acting to modify the biology that gives rise to disease rather than just treating disease symptoms. If further studies demonstrate that alicaforsen can reliably extend remission times, we may have the ability to transform current treatment paradigms and radically improve quality of life for patients living with various types of IBD. Additionally, the discovery of a second target of alicaforsen also has the potential to extend the product's application into many other inflammatory and autoimmune disease areas.”