4Sc : Yakult Honsha joins 4SC's pivotal RESMAIN study of resminostat in CTCL - 4SC receives milestone payment

Yakult Honsha joins 4SC's pivotal RESMAIN study of resminostat in CTCL - 4SC receives milestone payment

• RESMAIN - pivotal study to evaluate resminostat for maintenance treatment of patients with advanced-stage cutaneous T-cell lymphoma (CTCL)
• Yakult Honsha opens additional clinical centers in Japan
• Top-line results expected in the first half of 2019

Planegg-Martinsried, Germany, 27 March 2018 - 4SC AG (4SC, FSE Prime Standard: VSC) today announced, that Yakult Honsha Co., Ltd. (Yakult Honsha), 4SC's development partner for resminostat in Japan, joins 4SC's pivotal RESMAIN study. Yakult Honsha opens additional clinical centers in Japan and contribute patients to the RESMAIN study. Additionally, 4SC received a milestone payment.

The pivotal RESMAIN study, which is conducted as a multi-center, double blind, randomized, placebo-controlled, 150 patients 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 Japan. The study is progressing on track and top-line results are expected in the first half of 2019.

If the study results are positive, 4SC plans to submit applications for marketing approval of resminostat in CTCL in Europe and potentially the U.S. and Yakult Honsha will submit in Japan. If approved, resminostat would be the first histone deacetylase inhibitor approved for CTCL in Europe and the first and only drug approved for maintenance therapy in this indication in either Europe, Japan or the U.S.

Jason Loveridge, Ph.D., CEO of 4SC, commented: "We are delighted with the enthusiasm and energy of our Japanese partner in the development of resminostat. Just recently they confirmed to further investigate resminostat treatment in Japanese biliary tract cancer patients. Now Yakult Honsha have decided to join our pivotal RESMAIN study in CTCL. If the results of the RESMAIN study are positive, together, we look forward to being able to offer a new and effective treatment option to CTCL patients and physicians in large parts of the world."
 

- Press release ends -

Related articles

31 January 2018, Positive DSMB safety review of 4SC's pivotal RESMAIN study of resminostat in CTCL

5 December 2017, Significant milestone reached for pivotal RESMAIN study of resminostat as maintenance therapy in CTCL

10 October 2017, Resminostat demonstrates potential to significantly alleviate itching in CTCL patients

13 September 2017, Phase I study of 4SC's resminostat indicates efficacy in biliary tract cancer

Further information

About resminostat

Resminostat is orally administered and potentially offers a novel approach to treating a wide variety of cancers, both as monotherapy and in combination therapy with other anti-cancer drugs. Resminostat inhibits tumor growth and proliferation, causes tumor regression, and strengthens the body's immune response to cancer.

Resminostat has been shown to be well tolerated in several clinical trials. Resminostat is currently being investigated in a pivotal study in cutaneous T-cell lymphoma (CTCL) by 4SC. A Phase II study in biliary tract cancer is planned by 4SC's development partner Yakult Honsha in Japan. Amongst others, resminostat has previously been investigated in biliary tract or pancreatic cancer and hepatocellular carcinoma (HCC).

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, halting disease progression, improving quality of life and prolonging progression free and overall survival.

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 150 patients who suffer from advanced-stage cutaneous T-cell lymphoma (CTCL) and 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 and CTCL is acquired. 4SC anticipates top-line data to be available in 2019.

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 organ can be involved. None of the current therapeutic options achieve stable disease for long periods, with most patients progressing within six months on average.

Resminostat is being evaluated as maintenance treatment - prolonging the period patients are stable and not progressing. Recent preclinical data further suggests that resminostat has the potential to alleviate the itching in CTCL patients, thereby additionally improving the quality of life for patients.

About 4SC

4SC AG is a clinical-stage biopharmaceutical company developing small-molecule drugs that can target key indications in cancer with high unmet medical needs. Such drugs are intended to provide patients with innovative treatment options that are more tolerable and efficacious than existing therapies and provide a better quality of life.

4SC's pipeline is protected by a comprehensive portfolio of patents and currently comprises three key drug candidates in various stages of preclinical and clinical development: resminostat, 4SC-202 and 4SC-208.

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 December 2017 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A14KL72).

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.

Contact

Anna Niedl, Ph.D.
Corporate Communications & Investor Relations
anna.niedl@4sc.com
+49 89 700763-66