The pivotal RESMAIN study evaluating resminostat for maintenance treatment of advanced-stage cutaneous T-cell lymphoma (CTCL) will continue without modification, following a positive review by the Data Safety Monitoring Board (DSMB). The independent committee of clinical and drug safety experts reviewed cumulative safety data from the first 150 patients enrolled in the multi-center, double-blind, randomized, placebo-controlled trial. The study is designed to assess whether resminostat can prolong progression-free survival in CTCL patients who have achieved disease control with prior systemic therapy.
RESMAIN Study Details
The RESMAIN study is being conducted at over 50 clinical centers across 11 European countries and 5 centers in Japan. Originally designed to enroll 150 patients, the study has been expanded to include 190 patients to expedite the unblinding process. Patients are randomized 1:1 to receive either resminostat or placebo. Those on placebo who experience disease progression are offered resminostat in an open-label treatment arm. The primary endpoint is progression-free survival, with a key secondary objective being the time to symptom worsening (itching). Top-line results are anticipated by mid-2021.
Susanne Danhauser-Riedl, M.D., Chief Medical Officer of 4SC, stated, "Safety and tolerability are key requirements for patients and physicians considering a drug especially for the treatment of patients in the maintenance setting... The aim of a maintenance therapy and thus of our RESMAIN study is to make such remissions more durable, halting disease progression and improving the quality of life of patients."
Resminostat and CTCL
Resminostat is an orally administered class I, IIb and IV histone deacetylase (HDAC) inhibitor. CTCL is a rare disease affecting approximately 5,000 new patients in Europe annually. It arises from the malignant transformation of T-cells, primarily affecting the skin but potentially involving lymph nodes, blood, and visceral organs. Current treatment options for advanced-stage CTCL are limited, and while patients may respond initially, the duration of response is often short-lived. The RESMAIN study is investigating resminostat's potential to prolong periods of stable disease and improve the quality of life for CTCL patients.
Discontinuation of Biliary Tract Cancer Study
Yakult Honsha has decided to discontinue its Phase II study of resminostat in biliary tract cancer in Japan. This decision has no monetary impact on 4SC, as the program was fully funded by Yakult and did not include development milestones for 4SC. 4SC had no plans to independently pursue this indication.
