Sareum Holdings has received approval for its application submitted for initiation of a Phase I clinical trial of SDC-1801 in Australia.
Being developed as a potential new treatment for various autoimmune diseases, SDC-1801 mainly focuses on treating psoriasis, an autoimmune condition that affects the skin.
The study will examine the pharmacokinetic properties along with safety of an oral formulation of SDC-1801 in ascending doses given to healthy participants.
Upon receiving satisfactory safety data from the study, the company plans to initiate a Phase Ib trial next year in patients with psoriasis.
A TYK2/JAK1 inhibitor, SDC-1801 has strong clinical validation in treating psoriasis and psoriatic arthritis and showed benefits in maintaining a healthy immune system.
Sareum CEO Dr Tim Mitchell said: “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.
“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 I trial in the coming weeks.”
The application has been acknowledged by Australia’s medicines regulator, the Therapeutic Goods Administration, and approved by the Human Research Ethics Committee.