Many drugs miss clinical trial endpoints, often due to incorrect patient selection, choice of end points and dosing regimens. Further analysis of the data may reveal new insights and provide the basis for continuing development incorporating the lessons learnt.There are many well-known examples of drugs that failed for the indication they were originally intended for, but successfully developed for other conditions; everyone is aware of Viagra, originally developed for hypertension.
Atlantic Healthcare, based near Cambridge, UK, has established itself as a trans-Atlantic pharmaceutical company, building a diversified late-stage clinical pipeline. The company specializes in acquiring products with robust clinical data. “We have brought together deep expertise to identify, acquire, complete development, and market products directly to gastrointestinal (GI) clinicians,” said Toby Wilson Waterworth, Atlantic Healthcare’s CEO, and a Fellow of the Royal Society of Medicine. “Drugs with missed endpoints can offer exciting investment opportunities with reduced risk, lower cost to market, and increased return on investment,” he added.
Atlantic Healthcare’s leadership team, which also comprises COO, David Bennett, and CMO, Nermeen Varawalla, has a wealth of knowledge in developing and commercializing global healthcare portfolios and delivering international clinical studies.Atlantic Healthcare has six promising clinical programs based around two molecules: alicaforsen, for inflammatory bowel disease (IBD), and renzapride, for GI motility disorders (Fig. 1).
Fig. 1 | Atlantic Healthcare’s pipeline. Offering risk diversification and targeting multiple patient groups. GI, gastrointestinal; IBD, inflammatory bowel disease; UC, ulcerative colitis.
Camligo (alicaforsen): a potential game-changer for IBD patients
IBD is a long-term, debilitating condition of the GI tract that affects almost 7 million people worldwide. Patients experience symptoms related to gut endothelial inflammation which progresses to ulceration; the only cure is surgery to excise diseased tissue. The symptoms of IBD, which include abdominal pain and cramping, frequent and urgent bowel movements, energy loss and fatigue, are unpredictable. Symptoms can come and go, with patients experiencing ‘flare-ups’ when symptoms are more severe. The objective of treatment is to bring patients out of a ‘flare’ and maintain them in ‘remission’ for as long as possible.
Alicaforsen is being developed for flares in moderate to severe IBD. Most current therapies for this stage of disease work by suppressing the immune system. Speaking about such drugs at the 2019 United European Gastroenterology Week, William Sandborn, Director of the IBD Center at the University of California, San Diego, said: “None of these drugs provide transformative efficacy. New drugs are needed.”
Alicaforsen is an antisense oligonucleotide that inhibits production of ICAM-1, a cell surface receptor which is involved in inflammatory processes and is elevated in the gut endothelium of patients with IBD. Phase 2 data shows that a 6-week, once-a-day, course of alicaforsen enema, self-administered by the patient, can deliver disease remission, lasting on average 6 months. Furthermore, these studies demonstrated a positive safety profile with no known drug interactions. Alicaforsen has the potential to deliver a step change in treatment and establish a new class of therapy.
“We believe that alicaforsen has significant advantages over current therapies for moderate to severe IBD,” said Bennett. “It can be administered at home and might have a disease-modifying effect.”
Atlantic Healthcare is preparing a phase 3 trial for alicaforsen enema for distal ulcerative colitis, having agreed disease relevant endpoints with the U.S. Food and Drug Administration, and European Medicines Agency. The company is also progressing oral formulations for both Crohn’s disease and ulcerative colitis.
Renzapride: a promising treatment for GI motility disorders
Atlantic Healthcare has global rights to renzapride, an orally bioavailable small molecule that stimulates gut motility and reduces nausea based on its dual mode of action as a serotonin type 4 (5-HT4) receptor agonist and a partial 5-HT3 receptor antagonist.GI motility disorders affect 10–15% of the general population, typically before the age of 45. “There is no silver bullet in this area and KOLs advised new treatment options are urgently required,” said Bennett. In a large trial for constipation predominant IBS, renzapride has demonstrated efficacy in enhancing gastric emptying, reducing small bowel transit time and increasing colonic motility.
With these results Atlantic Healthcare is focusing on the development of renzapride for the management of GI motility in a number of rare diseases, including systemic scleroderma and cystic fibrosis, both of which are associated with chronic GI motility problems and for which there are no approved therapies. “Renzapride could make a big difference to the quality of life of these patients,” said Varawalla.
With the GI market set to grow to $31 billion per annum in the next 5 years and the need to move beyond systemic immune-suppressive therapies in a pandemic environment, Atlantic Healthcare’s drug portfolio could transform the treatment of a variety of GI diseases.
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