Alliance News) - Sareum Holdings PLC on Friday said its application to start a phase 1 clinical trial in Australia of its lead product, psoriasis drug SDC-1801, has been approved.

Sareum is a Cambridge-based biotechnology company developing kinase inhibitors for autoimmune diseases and cancers. SDC-1801 is a TYK2/JAK1 inhibitor being developed as a potential therapeutic for a range of autoimmune diseases, with an initial focus on the skin condition psoriasis.

Sareum said its application under the clinical trial notification scheme was approved by the Human Research Ethics Committee and acknowledged by the Therapeutic Goods Administration, Australia’s medicines regulator.

Sareum intends to commence a phase 1a study this year to investigate the safety and pharmacokinetics of an oral formulation of SDC-1801. The drug will be administered in ascending doses to healthy subjects. If Sareum obtains satisfactory safety data from the first study, it expects to start a phase 1b clinical study in psoriasis patients next year.

‘The approval of this application is a very important step for Sareum and we are now ready to bring our lead asset into clinical development,’ Chief Executive Officer Tim Mitchell commented.

He added: ‘We are very excited about the potential of SDC-1801, which we believe could offer superior efficacy compared to other currently-available small molecules for psoriasis and which has demonstrated a good safety profile in preclinical studies. We look forward to initiating our phase 1 trial in the coming weeks.’

Sareum’s shares were up 13% in London on Friday at 141.50 pence.

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