4SC AG is advancing towards potential market authorization for resminostat (Kinselby) as a maintenance therapy for advanced Cutaneous T-Cell Lymphoma (CTCL). The European Medicines Agency (EMA) is currently evaluating the Marketing Authorization Application (MAA) for resminostat, a critical step in bringing this treatment option to patients in Europe. The application is based on data from the pivotal RESMAIN study, which demonstrated the drug's efficacy in prolonging progression-free survival in patients with advanced CTCL who have achieved disease control with systemic therapy.
The RESMAIN study, a randomized, double-blind, placebo-controlled trial, involved 201 patients across 50 clinical centers in Europe and Japan. Patients with advanced-stage CTCL who had achieved disease control were randomized 1:1 to receive either resminostat or placebo. The primary endpoint of the study was progression-free survival (PFS). Data published in May 2023 confirmed that resminostat met this primary endpoint, demonstrating a statistically significant prolongation of PFS compared to placebo.
Clinical Significance of Resminostat in CTCL
CTCL is a rare malignancy of T-cells that primarily affects the skin, with potential involvement of lymph nodes, blood, and visceral organs in advanced stages. Approximately 5,000 new cases are diagnosed in Europe each year. While initial treatments can induce remission, these responses are often short-lived, and the disease progresses, highlighting the need for maintenance therapies to prolong remission and improve patients' quality of life.
Jason Loveridge, Ph.D., CEO of 4SC, stated, "Given the positive topline data from the RESMAIN study, we filed our Marketing Authorization Application for Kinselby to the EMA in February 2024 and received questions at the beginning of July as part of the MAA evaluation. Our goal is to address these questions by end 2024 and hopefully receive authorization to market Kinselby in the EU by the middle of next year. We continue to believe that we are well placed for the next stage in the development of Kinselby as we look to license the drug for commercialization in the EU, UK and Switzerland. Kinselby remains uniquely positioned as a maintenance therapy in CTCL where it can offer significant benefits for patients by halting disease progression. For the remainder of 2024, we are focused on getting EMA approval so we can make Kinselby available to patients as quickly as possible."
Regulatory and Commercialization Strategy
4SC submitted the MAA to the EMA in February 2024, and it was accepted for examination by early March 2024. The company is currently addressing questions raised by the EMA as part of the evaluation process, with the goal of providing comprehensive responses by the end of 2024. If the EMA grants marketing authorization, 4SC anticipates potential market availability in the EU by mid-2025.
In parallel with the regulatory process, 4SC is actively pursuing licensing opportunities for Kinselby in the European Union, United Kingdom, and Switzerland. This strategy aims to leverage partnerships to maximize the commercial potential of resminostat and ensure its availability to patients in these key markets.
Financial Outlook
As of June 30, 2024, 4SC reported cash reserves of €4.426 million. The company's management estimates that these funds will be sufficient to finance operations into Q1 2025. The company is also partnered with Yakult Honsha in Japan, who is responsible for filing a marketing application for Kinselby (resminostat) in Japan.
About Resminostat
Resminostat is an orally administered inhibitor of class I, IIb, and IV histone deacetylases (HDAC). It has demonstrated the ability to inhibit tumor growth and proliferation, induce tumor regression, and enhance the body's immune response to cancer. Its unique mechanism of action and favorable safety profile position it as a promising maintenance therapy for CTCL.
