Currently, some of the top medications for treating hidradenitis suppurativa (HS) include BIMZELX (bimekizumab) by UCB Biopharma, COSENTYX (secukinumab) by Novartis, and HUMIRA (adalimumab) by AbbVie/Eisai. Until 2023, HUMIRA dominated the market, even though its US patent expired in December 2016. AbbVie’s strong patent defense in the US helped extend its market exclusivity beyond Europe. In June 2023, the European Commission approved COSENTYX, a monoclonal antibody targeting IL-17A, for adults with moderate-to-severe HS who did not respond to conventional treatments. The FDA followed in October 2023 with the same approval. Additionally, UCB gained European Commission approval for BIMZELX in April 2024 to treat adults who did not respond well to systemic therapies.
The HS drug market is still underserved, but there is potential for growth with the development of multiple blockbuster treatments, similar to rheumatoid arthritis. Oral therapies could gain traction if they prove as effective as subcutaneous injections, providing new options in this niche market.
The next five years will likely see significant advancements in HS treatments, particularly with the development of targeted biologics and new immunomodulatory therapies. Researchers are expected to focus on precision medicine, aiming for personalized treatment strategies and exploring gene therapies to address the root causes of HS.
Some promising drugs in the pipeline include Povorcitinib (Incyte Corporation), Sonelokimab (MoonLake Immunotherapeutics), Izokibep (ACELYRIN), Spesolimab (Boehringer Ingelheim), Orismilast (UNION Therapeutics), RINVOQ (AbbVie), and Lutikizumab (AbbVie). Let’s dive deeper into the progress of these treatments.
Povorcitinib is a JAK1 inhibitor developed by Incyte Corporation that has shown efficacy in reducing abscesses and nodules in patients with moderate-to-severe HS. Currently undergoing Phase III clinical trials (STOP-HS studies), the drug may become the first oral treatment in the HS market. Trial results are expected by 2025, with potential approval by 2026-2027.
Sonelokimab (M1095) is a humanized nanobody targeting IL-17A and IL-17F. After completing a Phase II trial, the drug is being tested in two Phase III studies involving 800 patients. MoonLake expects to report topline results by mid-2025, with promising outcomes from the Phase II study already shared at the AAD 2024 annual meeting.
Izokibep is a small protein therapeutic designed to inhibit IL-17A with high potency, providing deep tissue penetration. In August 2024, ACELYRIN reported that their Phase III trial met its HiSCR75 goal at 12 weeks. Izokibep shows comparable efficacy to next-gen IL-17 inhibitors and is currently in advanced trials for HS, psoriatic arthritis, and noninfectious uveitis.
– RINVOQ by AbbVie: A JAK1 inhibitor, RINVOQ, is approved for several inflammatory conditions, including rheumatoid arthritis and Crohn’s disease. In July 2023, AbbVie initiated a Phase III trial to evaluate RINVOQ for patients with moderate-to-severe HS who did not respond to anti-TNF therapy.
– Lutikizumab by AbbVie:Lutikizumab (ABT-981) is an experimental treatment targeting IL-1α and IL-1β, currently in Phase III development for HS after demonstrating better responses in Phase II trials.
– Spesolimab by Boehringer Ingelheim: Spesolimab is an IL-36 receptor antibody marketed as SPEVIGO for treating generalized pustular psoriasis. The drug is also being studied for other IL-36-driven conditions, including HS, in Phase II trials.
The future of HS treatment looks promising, with ongoing advancements in biologics and targeted therapies. Currently, the only FDA-approved biologics for HS are HUMIRA and COSENTYX, with BIMZELX approved in Europe. As biosimilars of HUMIRA, like AMJEVITA, enter the market, the treatment landscape is expected to diversify.
There is a growing demand for more precise and effective treatments as existing therapies have variable patient responses and side effects. New treatments, such as JAK and IL-17 inhibitors, are expected to offer more personalized solutions. Researchers are also focusing on the genetic and immunological aspects of HS to develop more targeted therapies, potentially transforming patient outcomes and improving quality of life for those with this chronic condition.
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