The global psoriasis therapeutics market is expected to be valued at USD 21.4 billion by 2022 (source). Psoriasis affects approximately 125 million people worldwide, and nearly one quarter of people with psoriasis have cases that are considered moderate to severe. A major issue facing drug makers is that the cause of psoriasis is not fully understood. This has led to the ecosystem becoming saturated with many drug therapies that target key inflammatory pathway molecules; mostly TNF (tumor necrosis factor) inhibitors and IL-17 inhibitors, as opposed to disease modifying drugs. As a result, a key unmet need facing psoriasis patients today is a lack of access to efficient medicines that are also attractive enough to ensure patient adherence to treatment regimens.
The latest drug therapies to hit the market are the IL-23p19 inhibitors. These include:
● Tremfya® (Janssen)
● Ilumya® (Sun Pharma) which were both approved this past last year
Risankizumab®, AbbVie’s IL-23p19 inhibitor candidate, has made recent news with its Biologics License and Marketing Authorization Applications to the FDA and EMA respectively, which suggests that it will hit the market relatively soon.
With AbbVie’s recent push to get Risankizumab® market ready, we will map out several factors that differentiate Risankizumab® from its competition, and how this drug will affect the future of psoriasis.
One of the key molecular pathways in the pathogenesis of psoriasis is the IL-23/Th-17 axis, and the treatments currently on the market work downstream of this axis, of which a wave of therapeutics target interleukin 17 (IL-17). Risankizumab® offers a unique mode of action which demonstrates superior outcomes by targeting a different molecule, IL-23, which results in a reduced pro-inflammatory response. Data shows that this specific inhibition is more efficient, if not better, than Risankizumab’s® counterparts. However, the exact reason why has yet to be identified.
The need for more convenient psoriasis drugs that will be adhered to by patients will be one of Risankizumab’s® key selling points. Late stage clinical trials indicate that the drug’s ability to decrease psoriasis severity is equal to that of its direct competitor, Tremfya®. AbbVie offers a less cumbersome patient journey that will significantly impact patient lifestyles by reducing the dosing regimen from every 8 to 12 weeks.
So far, Risankizumab® has undergone four multi-center Phase 3 clinical trials, with each trial displaying significant PASI90 (Psoriasis Area and Severity Index*) results, the current gold standard for measuring clinical efficacy of drugs. AbbVie’s drug stands out from the competition with the full plaque clearance scores, or PASI100, that were observed during two specific trials. Furthermore, these scores were so impressive that in AbbVie’s ongoing clinical trial, PASI100 is considered a primary endpoint, indicating that the emergence of more efficient therapies such as Risankizumab® may lead to full plaque clearances as a new standard primary endpoint.
*AbbVie, J&J, & Sun Pharma (drug licensed from Merck & Co. in 2014) are the only big companies involved in clinical trials
With the heavy patent protection on Humira®, AbbVie’s blockbuster drug, nearing expiration, and the rise of biosimilars knocking on their door, AbbVie has set itself up to remain at the top of the psoriasis ecosystem with a drug demonstrating improved target specificity, decreased dosing regimen, and enhanced drug efficacy. Furthermore, Risankizumab® is being tested for treating Crohn’s Disease and asthma, which will surely bolster AbbVie’s immune disease strategy. Humira's younger sister is about to hit the market - Janssen and Sun Pharma: be prepared!
*PASI – The Psoriasis Area and Severity Index (PASI) is a score that is widely used in research to assess the progress of people receiving treatment for psoriasis. For example, PASI 90 represents the percentage of patients who have achieved 90% reduction in their PASI score from baseline.
Written by Yoan Ezerzer
Life Sciences Analyst. Yoan is an analyst at Signals working in the life sciences team on projects in the field of autoimmune disease. He holds a BSc in pharmacology from McGill University.