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A Lower Risk, Higher Value, Late-Stage Pipeline for Gastrointestinal Diseases

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A Lower Risk, Higher Value, Late-Stage Pipeline for Gastrointestinal Diseases ADVERTISEMENT FEATURE Atlantic Healthcare www.atlantichc.com A lower risk, higher value, late-stage pipeline for gastrointestinal diseases Atlantic Healthcare plc is raising funds to advance clinical trials for new chemical entities: alicaforsen for inflammatory bowel disease, and renzapride for gut motility disorders in rare diseases. Regulatory Many drugs miss clinical trial endpoints, often Indication Form Pre-clinical Phase 1 Phase 2a Phase 2b Phase 3 due to incorrect patient selection, choice of end approval points and dosing regimens. Further analysis of UC enema the data may reveal new insights and provide the Camligo basis for continuing development incorporating UC tablet AHC-1145 the lessons learnt. IBD There are many well-known examples of drugs Crohn’s tablet that failed for the indication they were originally Alicaforsen for AHC-1062 intended for, but successfully developed for other conditions; everyone is aware of Viagra, originally Systemic developed for hypertension. scleroderma GI complications Atlantic Healthcare, based near Cambridge, UK, Cystic fibrosis has established itself as a trans-Atlantic pharmaceu- GI complications tical company, building a diversified late-stage clini- GI Motility cal pipeline. The company specializes in acquiring Renzapride for Undisclosed indication products with robust clinical data. “We have brought together deep expertise to identify, acquire, com- Fig. 1 | Atlantic Healthcare’s pipeline. Offering risk diversification and targeting multiple patient groups. plete development, and market products directly to GI, gastrointestinal; IBD, inflammatory bowel disease; UC, ulcerative colitis. gastrointestinal (GI) clinicians,” said Toby Wilson Waterworth, Atlantic Healthcare’s CEO, and a Fellow William Sandborn, Director of the IBD Center at the GI motility disorders affect 10–15% of the gen- of the Royal Society of Medicine. “Drugs with missed University of California, San Diego, said: “None of eral population, typically before the age of 45. endpoints can offer exciting investment opportuni- these drugs provide transformative efficacy. New “There is no silver bullet in this area and KOLs ties with reduced risk, lower cost to market, and drugs are needed.” advised new treatment options are urgently increased return on investment,” he added. Alicaforsen is an antisense oligonucleotide that required,” said Bennett. In a large trial for consti- Atlantic Healthcare’s leadership team, which also inhibits production of ICAM-1, a cell surface recep- pation predominant IBS, renzapride has demon- comprises COO, David Bennett, and CMO, Nermeen tor which is involved in inflammatory processes and strated efficacy in enhancing gastric emptying, Varawalla, has a wealth of knowledge in developing is elevated in the gut endothelium of patients with reducing small bowel transit time and increasing and commercializing global healthcare portfolios IBD. Phase 2 data shows that a 6-week, once-a-day, colonic motility. and delivering international clinical studies. course of alicaforsen enema, self-administered by With these results Atlantic Healthcare is focusing Atlantic Healthcare has six promising clinical pro- the patient, can deliver disease remission, lasting on on the development of renzapride for the manage- grams based around two molecules: alicaforsen, for average 6 months. Furthermore, these studies dem- ment of GI motility in a number of rare diseases, inflammatory bowel disease (IBD), and renzapride, onstrated a positive safety profile with no known including systemic scleroderma and cystic fibrosis, for GI motility disorders (Fig. 1). drug interactions. Alicaforsen has the potential to both of which are associated with chronic GI motility deliver a step change in treatment and establish a problems and for which there are no approved thera- Camligo (alicaforsen): a potential new class of therapy. pies. “Renzapride could make a big difference to game-changer for IBD patients “We believe that alicaforsen has significant the quality of life of these patients,” said Varawalla. IBD is a long-term, debilitating condition of the GI advantages over current therapies for moderate to With the GI market set to grow to $31 billion per tract that affects almost 7 million people world- severe IBD,” said Bennett. “It can be administered at annum in the next 5 years and the need to move wide. Patients experience symptoms related to home and might have a disease-modifying effect.” beyond systemic immune-suppressive therapies gut endothelial inflammation which progresses to Atlantic Healthcare is preparing a phase 3 trial in a pandemic environment, Atlantic Healthcare’s ulceration; the only cure is surgery to excise dis- for alicaforsen enema for distal ulcerative colitis, drug portfolio could transform the treatment of a eased tissue. The symptoms of IBD, which include having agreed disease relevant endpoints with the variety of GI diseases. abdominal pain and cramping, frequent and urgent U.S. Food and Drug Administration, and European For more information about Atlantic Healthcare, bowel movements, energy loss and fatigue, are Medicines Agency. The company is also progress- investment, alicaforsen or renzapride, please unpredictable. Symptoms can come and go, with ing oral formulations for both Crohn’s disease and contact using the details below. patients experiencing ‘flare-ups’ when symptoms ulcerative colitis. are more severe. The objective of treatment is to bring patients out of a ‘flare’ and maintain them in Renzapride: a promising treatment ‘remission’ for as long as possible. for GI motility disorders Adam Michael, Head of Communications Alicaforsen is being developed for flares in Atlantic Healthcare has global rights to renzapride, Atlantic Healthcare moderate to severe IBD. Most current therapies an orally bioavailable small molecule that stimulates Cambridge, UK for this stage of disease work by suppressing the gut motility and reduces nausea based on its dual CONTACT Tel: +44 1799 512055/+44 777 5881813 immune system. Speaking about such drugs at the mode of action as a serotonin type 4 (5-HT4) recep- Email: [email protected] 2019 United European Gastroenterology Week, tor agonist and a partial 5-HT3 receptor antagonist. B28 | December 2020 | www.nature.com/biopharmdeal ADVERTISER RETAINS SOLE RESPONSIBILITY FOR CONTENT.
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