4SC receives Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL from the US FDA

The US Food and Drug Administration (FDA) has granted Germany based 4SC’s application for Orphan Drug Designation for resminostat (Kinselby) for cutaneous T cell lymphoma (CTCL), the company said in a press release on Wednesday.

The company said that Marketing Authorisation Application (MAA) for Kinselby (resminostat) in the EU remains on track for filing in Q1 2024.

Jason Loveridge, the CEO of 4SC, said that receiving orphan drug designation for resminostat provides 4SC with a number of important benefits, most crucially 7 years’ market exclusivity in the US, a key foundation of the company’s efforts to commercialise Kinselby. “We are currently preparing a marketing authorisation application for Kinselby in the EU, which remains on track for submission in Q1 2024,” Loveridge said.

About Kinselby (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.