4SC – Resminostat and RESMAIN Study Update
- Independent Data Safety Monitoring Board recommends RESMAIN study to continue without modification following review of cumulative safety data from first 175 patients enrolled
Planegg-Martinsried, Germany, 16 June 2021 – 4SC AG (4SC, FSE Prime Standard: VSC) today announced, that the Data Safety Monitoring Board (DSMB), an independent committee of clinical and drug safety experts, recommends continuation of the ongoing pivotal RESMAIN study without modification of the study protocol. A further DSMB meeting was scheduled recently to review cumulative unblinded safety data after 175 patients had been enrolled, including safety data collected from patients in the study during the current COVID-19 pandemic.
The pivotal RESMAIN study, which is conducted as a multi-center, double blind, randomized, placebo-controlled study, evaluates resminostat for maintenance treatment of patients with advanced-stage cutaneous T-cell lymphoma (CTCL) who have achieved disease control with prior systemic therapy, at more than 50 clinical centers in 11 European countries, and 5 centers in Japan. As previously reported, recruitment had been affected by the global pandemic, but was now recovering such that it is anticipated that the last patient will be enrolled into the RESMAIN study by Q4 2021.
Susanne Danhauser-Riedl, M.D., Chief Medical Officer of 4SC, commented: “Our goal is always to ensure the utmost safety of study participants while preserving the quality and integrity of the data generated. During the past 15 months we have had to deal with the real and significant challenges of conducting our clinical studies under very difficult and exceptional circumstances as a result of the global coronavirus pandemic. As such, I am very pleased that the DSMB has identified no safety concerns and that the RESMAIN study can continue without modification. We are certainly encouraged by the positive outcomes of the repeated and regular independent DSMB safety reviews and we now continue the study with the aim of completing recruitment in 2021 and seeing top line data as soon as possible thereafter.”
Related articles
31 January 2020, 4SC – Resminostat and RESMAIN Study Update
27 September 2019, Key resminostat scientific data to be presented at EORTC-CLTF meeting in Athens
28 January 2019, 4SC’s pivotal RESMAIN study of resminostat in CTCL receives second positive safety review
20 November 2018, 4SC reaches significant milestone with enrollment of 100 patients in pivotal RESMAIN study of resminostat as CTCL maintenance therapy
28 June 2018, New data supports resminostat’s mechanism of action in CTCL maintenance therapy
27 March 2018, Yakult Honsha joins 4SC’s pivotal RESMAIN study of resminostat in CTCL – 4SC receives milestone payment
About 4SC
4SC AG is a clinical-stage biopharmaceutical company developing small-molecule drugs that target key indications in cancer with high unmet medical needs. 4SC’s pipeline is protected by a comprehensive portfolio of patents and currently comprises two drug candidates in clinical development: resminostat and domatinostat.
4SC aims to generate future growth and enhance its enterprise value by entering into partnerships with pharmaceutical and biotech companies and/or the eventual marketing and sales of approved drugs in select territories by 4SC itself.
4SC is headquartered in Planegg-Martinsried near Munich, Germany. The Company had 48 employees as of 31 March 2021 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A14KL72).
About resminostat
Resminostat is an orally administered class I, IIb and IV histone deacetylase (HDAC) inhibitor that potentially offers an approach to treating different kinds of cancer. Resminostat demonstrated that it is well tolerated and can inhibit tumor growth and proliferation, cause tumor regression, and strengthen the body’s immune response to cancer.
Resminostat is currently being investigated in a pivotal study in cutaneous T-cell lymphoma (CTCL) as maintenance treatment by 4SC in Europe and by Yakult Honsha in Japan.
About cutaneous T-cell lymphoma (CTCL)
CTCL is a rare disease with approximately 5,000 patients being newly diagnosed in Europe each year. The disease arises from malignant transformation of T-cells, a specialized subgroup of immune cells, primarily affects the skin, but may ultimately involve lymph nodes, blood and visceral organs.
Currently, CTCL is not curable and treatment options for advanced-stage CTCL are limited. Although patients respond to the available treatment options, the duration of response is often short-lived and declines as the severity of the disease increases. The key therapeutic challenge in advanced-stage CTCL is therefore to make remissions more durable by halting disease progression and improving patient’s quality of life.
About the RESMAIN study – resminostat for maintenance treatment of CTCL
The pivotal RESMAIN study is being conducted at more than 50 clinical centers in 11 European countries and Japan. It will include up to 190 patients who suffer from advanced-stage cutaneous T-cell lymphoma (CTCL) that have achieved disease control with systemic therapy. The patients are randomized 1:1 to receive either resminostat or placebo. Patients who experience disease progression – while being on placebo – will be offered resminostat in an open label treatment arm.
The primary goal of the study is to determine whether maintenance treatment with resminostat prolongs progression-free survival and the key secondary objective is to prolong the time to symptom worsening (itching). A comprehensive biomarker program is also included in the study to ensure vital knowledge about the biological background of resminostat treatment in CTCL.
About the concept of maintenance therapy
The pivotal RESMAIN study is focused on patients with advanced-stage, incurable cutaneous T-cell lymphoma (CTCL). Such patients suffer from painful and itchy skin lesions resulting in disfigurement and a severely impaired quality of life. Furthermore, lymph nodes, blood or visceral organs can be involved. The current therapeutic options rarely provide long-lasting responses or stabilization of disease for meaningful periods, with most patients progressing within several months.
Resminostat is being evaluated as maintenance treatment – a unique innovative treatment approach in CTCL (Stadler et al., 2021) – intended to prolong the period patients are stable and not progressing. Furthermore, recent preclinical data suggests that resminostat has the potential to alleviate the itching in CTCL patients, thereby additionally improving their quality of life.
Forward-looking information
Information set forth in this press release contains forward-looking statements, which involve risks and uncertainties. The forward-looking statements contained herein represent the judgement of 4SC as of the date of this press release. Such forward-looking statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond 4SC’s control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. 4SC expressly disclaims any obligation or undertaking to release any updates or revisions to any such statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.