Crohn’s disease, an Inflammatory Bowel Disease (IBD) that is complex, idiopathic, progressive and destructive, has an unknown etiology. The several factors causing it (including the immune system) must be considered in three primary contexts: environment, genetics and gut microbiota.
Modern Crohn’s disease treatments either target specific cytokines in the inflammatory cascade or use systemic immunomodulation as their mechanism of action. Despite the introduction of several new classes of biologic therapy – including the Janus Kinase (JAK) inhibitor and upadacitinib – Tumor Necrosis Factor (TNF) antagonists still play a central role in the treatment of moderate-to-severe Crohn's disease.
Comparative analysis by WNS of the efficacy profiles of these therapies suggests that infliximab consistently ranks high when it comes to the induction of clinical response and clinical remission. However, the induced response is rarely maintained for longer than a year. Furthermore, while biologics are the primary treatment option for patients with Crohn's disease, these therapies are not universally effective and have the potential for adverse events. Recent research suggests that targeting other pathways, either alone or in combination with an immune pathway, is needed to control the disease better.
In this regard, gut microbiota forms a promising area for exploration. The gut microbiome has been linked to the development and perseverance of IBD. There is now emerging interest in treatments that positively impact the gut microbiome. This could be an effective approach to Crohn’s treatment and prevention.
Various pharmaceutical companies have already entered the market to investigate and develop treatments centered on a microbiome modulation strategy. While some, like Genentech, have taken their first step and entered a strategic collaboration to discover, develop and commercialize biomarkers, targets and medicines for IBD, other smaller companies already have novel assets, including microbiome modulators, in early clinical testing phases.
To address ongoing changes in the clinical, commercial and regulatory landscape, pharmaceutical companies must adopt a game plan that bolsters their operating models and opens up new avenues for exploration. An effective strategic collaboration is required with a domain specialist with expertise in competitive intelligence and clinical research support to fundamentally improve decision-making with sharp and forward-looking insights.
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