Simcere Pharmaceutical’s IL-2 mutant fusion protein (IL-2 mu-Fc), SIM0278, has entered a Phase II trial in China, for moderate-to-severe atopic dermatitis (AD) treatment.
This study will assess the pharmacokinetics, efficacy, and safety of continuous subcutaneous administration of SIM0278 in affected patients, deploying a multi-centre, placebo-controlled, double-blind, randomised approach.
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AD is a recurrent, inflammatory, chronic skin condition, with symptoms such as erythema, dry skin, and itching.
SIM0278 benefits from Simcere’s protein engineering platform, embodying mutations designed to decrease binding to effector T cells while retaining high affinity for regulatory T cells (Tregs).
This selective mechanism helps promote Treg activation, restores immune balance, and avoids impact on natural killer cells or effector T cells.
Completed Phase I trial of SIM0278 in China indicated initial efficacy signals, good tolerability, and appropriate pharmacokinetic profiles.
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By GlobalDataThe initial dose administration took place at Hangzhou First People’s Hospital.
Simcere chief medical officer Dr Aik Goh said: “The clinical progress of SIM0278 significantly strengthens Simcere’s leading position in the field of autoimmune diseases.
“The initiation of Phase II clinical trials also marks a significant step forward in the project’s global clinical development plan. We look forward to working with our partner to bring this innovative drug to patients worldwide as soon as possible.”
Simcere entered an exclusive license agreement with Almirall in September 2022, granting the latter rights for developing and marketing SIM0278 for all indications outside Greater China.
Almirall chief scientific officer Karl Ziegelbauer said: “This partnership reinforces our commitment to pushing the boundaries of science and patient-centric innovation to deliver impactful solutions for unmet dermatological needs.”
Simcere operates across anti-infection, autoimmune diseases, oncology, and neuroscience.
