The global inflammatory bowel disease treatment market size is expected to reach USD 22.4 billion by 2026, according to a new report by Grand View Research, Inc., registering a 4.4% CAGR during the forecast period. Increasing prevalence and incidence of Crohn’s disease and ulcerative colitis (UC) one of the major factors contributing to the market.
The current medical approach for patients with IBD is symptomatic care and mucosal healing and follows a stepwise medication approach, escalating the medical regimen until a response is achieved. In the early stages of IBD, low-cost therapies like aminosalicylates are prescribed, stepping up to steroids and immunosuppressants, inexpensive agents with variable efficacy and side effect risks, before the introduction of injected biologics (anti-tumour necrosis factor (TNF) agents). In the last decade, injected biologic agents, in particular anti-TNF agents, have substantially extended the therapeutic armamentarium of IBD. However, these drugs have a number of contraindications and side effects, including opportunistic infections and malignancies. Thus, there are significant growth opportunities to position JEL3108 as a safe, convenient and efficacious topical alternative to existing injected biologics.
JEL3108 will initially be a gel formulation to locally treat the rectal form of ulcerative colitis (ulcerative proctitis). This is the most frequent method of delivery for this conditon. Success as a rectal delivery gel will support the further development of an oral delivery formulation with delayed release to treat the whole large colon in UC. Successful rectal and oral delivery of a novel peptide formulation will be a unique property of JEL3108 and the safety and efficacy profile characterised during development will further drive its premium place in the market.
No single firm or product dominates the market and many therapies are coming to the end of their patent life and so there is plenty of space for new safe and effective treatments. JEL3108, if successful, would represent a step-change in treatment for clinicians and patients because it would offer an effective drug with which to treat disease flares that can also be used for long-term maintenance. In addition, by using a peptide agent (a biologic) to inhibit an intracellular target we may see a significant reduction in side effects seen with current therapies.
Due to its chronic and unpredictable disease course, young age of onset, and the need for life-long, and lack of suitable therapies, IBD is an important global public health problem. As curative treatments are lacking, the incidence and prevalence of the disease are increasing. Currently an estimated 2.5–3 million people in Europe are affected by IBD, with direct healthcare cost of 4.6–5.6 billion Euros/year. In the US there is a prevalence of 238 per 100,000 adults and the number of ulcerative colitis patients are increasing in emerging economies. Figure 12 illustrates the global UC sales by region through to 2022.
When our ex-vivo data translates to clinical efficacy then our proposed product would have impact in both terms of pharmacoeconomics as well as patient quality of life and productivity.
The UC market consists of a plethora of small-molecule drugs and TNF-inhibiting biologics that offer relatively good safety and moderate efficacy. Figure 13 provides analysis of the company portfolio in UC during the next 10 years split by disease severity (mild to moderate and moderate to severe) and where Carocell Bio should fit.
Johnson & Johnson (J&J) has been a dominant player in the UC market since 2006, due to the success of Remicade, an intravenous (IV) TNF-alpha inhibitor. In 2013, Simponi, a subcutaneous (SC) TNF-α inhibitor, was launched in the US and 5EU. This brand, which has better efficacy in UC than Abbvie’s Humira, will allow J&J to retain its positive standing in the UC market for a longer period of time.
Pfizer is currently developing three different drugs for the treatment of UC, including Xeljanz, a janus kinase (JAK) inhibitor, and is striving to re-enter the UC market. Takeda’s Entyvio, is forecast to have a slow start, but will gradually increase its market share. Roche’s etrolizumab is a “me-too” drug to Entyvio, which is forecast to encroach on the SC therapies that are already used for UC, such as Humira and Simponi. Roche is promoting the drug as a better treatment for TNF-blocker-naïve patients.
JEL3108 will be ideally positioned as a novel, safe and highly effective topical biologic to target all severities of IBD with the prospect of treating the flares as well as being used for long-maintenance.
Initial positive human clinical proof of concept with a topical local formulation to treat UC of the rectum (ulcerative proctitis) will facilitate the future development of an oral delivery technology for the long-term treatment of IBD.
Drug Discovery and Development is a highly competitive environment but with a large capacity for innovative new products that work. However, as large Pharma moves further toward a “search and develop” business model it creates a significant business opportunity for agile small to medium sized pharmaceutical and biopharmaceutical companies to develop de-risked projects ready for out-licensing to these large, cash rich, companies for further clinical development and market approval. This is where Carocell Bio fits and we are already speaking with potential licencing partners in the IBD field who would be interested in progressing JEL3108 toward and into the clinic.
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