On February 1, 2022 The Management Board and Supervisory Board of 4SC AG (FSE Prime Standard: VSC) reported that as a result of a review of more recent clinical data 4SC discontinues the development program for domatinostat, an orally administered small molecule class I selective HDAC inhibitor (Press release, 4SC, FEB 1, 2022, View Source [SID1234608076]).
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4SC will now focus its resources completely on resminostat and on seeing an outcome to the ongoing pivotal RESMAIN study in CTCL and prepare for its commercialization in case of positive data. 4SC continues to be well funded and expects to have sufficient cash in-hand to obtain topline results from the RESMAIN study.
Jason Loveridge, Ph.D., CEO of 4SC commented: "As a company, we understand that developing new medicines for patients suffering from malignant diseases is an important, but difficult undertaking. Accordingly, we continually evaluate our development programs as data emerge to support prudent decisions that provide the greatest potential to create value for both patients and our shareholders.
It is of course disappointing that we have decided to discontinue development of domatinostat, including all currently ongoing clinical studies. The preclinical data we generated for the candidate were very persuasive, but the clinical information now available, and which will be published in due course, indicates that domatinostat is unlikely to provide value to patients, physicians, or shareholders. We thank the investigators, the patients, and support staff who have participated in this important research program and will now focus our resources on resminostat and expect to reach an outcome for our pivotal study in CTCL as planned in 2023."