Relief Therapeutics Announces IRB Approval of Investigator-Initiated Trial Evaluating RLF-TD011 as an Adjunctive Treatment for Cutaneous T-Cell Lymphom - Seite 2

“This investigator-initiated trial represents an important step in the clinical development pathway of RLF-TD011,” said Nermeen Varawalla, M.D., D.Phil., M.B.A., chief medical officer, Relief Therapeutics. “Data from this study will be utilized to facilitate the design and conduct of follow-on, multi-center, pivotal clinical trials, which will potentially serve as the clinical support for our eventual submissions to the U.S. Food and Drug Administration and European Medicines Agency for RLF-TD011 as an effective, convenient and well-tolerated treatment for CTCL, thereby addressing an important unmet medical need in an intractable, incurable disease.”

ABOUT CUTANEOUS T-CELL LYMPHOMAS

Cutaneous t-cell lymphomas (CTCLs) are a rare group of disorders known as non-Hodgkin’s lymphomas characterized by abnormal accumulation of malignant t-cells in the skin that can result in the development of rashes, plaques and tumors. Because CTCL is rare and often looks like eczema or another common skin disease, it can be difficult to diagnose. While there are many types of CTCLs, the most common diagnoses are mycosis fungoides, primary CTCL and primary cutaneous anaplastic large cell lymphoma^[1]. The overall incidence rate of CTCL was 8.55 per 1 million with MF being the subtype with the highest incidence, at 5.42 per 1 million^[2]. The overall incidence of CTCL in the U.S. and Europe has increased, a reflection of better diagnostic tools and increased awareness among physicians and patients, which has led to improved disease detection^[3].

According to Fortune Business Insights, the North American CTCL therapeutics market size is projected to hit an annual valuation of USD $587.4 million by 2028, registering a 13.6 percent compound annual growth rate (CAGR) in the 2021-2028 period^[4]. The market value was estimated to be worth USD $225.9 million in 2020 and reached USD $240.9 million in 2021. The increasing burden of CTCL in the region is slated to increase the demand for novel CTCL therapeutics solutions. Cleveland Clinic reports that more than 3,000 new CTCL patients are diagnosed in the U.S. each year and about 16,000-20,000 individuals suffer from mycosis fungoides, the most common form of CTCL that is linked to skin-localized immune cell stimulation.