FREE

Sareum Holdings - Sotyktu approval positive read-across for SDC-1801

On 9 September 2022 the US FDA approved Bristol Myers Squibb’s first-in-class tyrosine kinase 2 (TYK2) inhibitor Sotyktu (deucravacitinib) for the treatment of moderate-to-severe plaque psoriasis in adults, making it the first selective TYK2 inhibitor to be approved for any indication. We expect this news to have a positive read-across for Sareum Holdings’ lead asset, SDC-1801, a dual TYK2/JAK 1 inhibitor. As a reminder, Sareum recently announced the filing of a clinical trial authorisation application for SDC-1801 with the UK Medicines and Healthcare products Regulatory Agency. The Phase Ia (in healthy subjects) is planned to start in Q4 CY22, and a Phase Ib (in psoriasis patients) is planned to start in CY23 subject to regulatory approval. The approval of Sotyktu was widely expected and validates the potential of this new asset class, in our opinion. Sareum asserts that SDC-1801’s dual targeting could potentially accord superior efficacy, which if proved could translate to a sizeable market opportunity for Sareum.