Sareum Regulatory News (SAR)

Sareum Holdings PLC

("Sareum" or the "Company")

Sareum notes the US FDA approval of Sotyktu™ (deucravacitinib), for Moderate-to-Severe Plaque Psoriasis, the first TYK2 inhibitor to gain FDA approval

Cambridge, UK, 12 September 2022 - Sareum Holdings plc (AIM: SAR), a clinical stage biotechnology company developing next generation kinase inhibitors for autoimmune disease and cancer, notes the announcement from Bristol Myers Squibb (BMS) that the US Food and Drug Administration (FDA) has approved Sotyktu™(deucravacitinib), a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

This announcement supports Sareum's confidence in its broader portfolio of TYK2/JAK1 inhibitors focused on autoimmune disease.

This is the first approval by the FDA of a medicine based on TYK2, a member of the JAK cell signalling family. Sareum believes it provides clinical validation for this class of therapeutic, and for the broader TYK2/JAK1 signalling family, which underpins Sareum's clinical portfolio.

The Company believes the TYK2/JAK1 signalling pathway which it is pursuing offers potential for superior efficacy compared with agents, such as deucravacitinib, which block just one of the two kinases.

The Sotyktu approval is based on a pivotal Phase 3 study of deucravacitinib which demonstrated superior efficacy against placebo and standard of care. It is also encouraging to note that deucravacitinib was well tolerated in the Phase 3 study. Unlike some other medicines in the JAK inhibitor class, the FDA is not requiring boxed warnings for deucravacitinib around the heightened risk of serious heart-related events.

"We're encouraged that the FDA has approved Sotyktu (deucravacitinib)," said Tim Mitchell, CEO of Sareum. "We believe this validates the potential of this new therapeutic class and supports our own growing confidence around our lead programme and our broader portfolio of TYK2/JAK1 inhibitors

"TYK2/JAK1 inhibition has demonstrated benefits in maintaining a healthy immune system and has strong clinical validation in psoriasis and psoriatic arthritis. Sareum has submitted a Clinical Trial Authorisation (CTA) to the UK's Medicines and Healthcare Products Regulatory Agency to initiate a clinical trial of SDC-1801, with an initial focus on psoriasis, and hopes to begin dosing patients in 2023, subject to regulatory approvals."

Sareum will update on the regulatory progress of SDC-1801 in due course.

Bristol Myers Squibb's announcement can be found here.

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About Sareum

Sareum Holdings (AIM:SAR) is a clinical stage biotechnology company developing next generation kinase inhibitors for autoimmune disease and cancer.

The Company is focused on developing next generation small molecules which modify the activity of the JAK kinase family and have best-in-class potential. Its lead candidate, SDC 1801, simultaneously inhibits TYK2 and JAK1. SDC1801 is a potential treatment for a range of autoimmune diseases, which has entered clinical development with an initial focus on psoriasis. Sareum is also developing SDC1802, a TYK2/JAK1 inhibitor with a potential application for cancer immunotherapy.

Sareum is also eligible to receive certain milestone payments and future royalties on SRA737, a clinical-stage, oral, selective Checkpoint kinase 1 (Chk1) inhibitor that targets cancer cell replication and DNA damage repair mechanisms. SRA737 is licensed to GSK, which acquired the previous licence holder, Sierra Oncology, in June 2022

Sareum Holdings plc is based in Cambridge, UK, and is listed on the AIM market of the London Stock Exchange, trading under the ticker SAR. For further information, please visit the Company's website at www.sareum.com