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Almirall initiated a phase I clinical study of SIM0278 (ALM223)

Release time:2023-12-22

Simcere Pharmaceuticals' self-developed product has made a significant progress overseas


On December 21, 2023, Almirall S.A. (BME: ALM), a global pharmaceutical company focused on medical dermatology, announced the initiation of the phase I study, evaluating the safety, pharmacokinetics, immunogenicity and pharmacodynamics of SIM0278 (overseas code: ALM223).


SIM0278 is an interleukin 2 mutant fusion protein (IL-2 muFc), which could selectively activate regulatory T cells (Tregs), and is expected to be developed for the treatment of a variety of autoimmune diseases.


In September 2022, Simcere and Almirall signed an exclusive license agreement, granting Almirall rights to develop and commercialize this product outside of the Greater China, with a total milestone amount of approximately 500 million USD.


Simcere is responsible for the clinical development of SIM0278 in China and the Phase I study was initiated in August 2023.


SIM0278 is a Treg-preferring IL-2 mutated Fc fusion protein developed at the internal protein engineering platform of Simcere, reducing the affinity to effector T cells but retaining the high affinity to Tregs through the introduction of the corresponding mutations, which in turn improves the selectivity for Tregs and achieves the effect of restoring the body's immune balance. It has the potential to be developed for the treatment of a variety of autoimmune diseases.


In the communication made by Almirall, Karl Ziegelbauer, Ph.D., Almirall’s Chief Scientific Officer said:"We are very pleased about the initiation of the development in humans of this innovative IL-2 mutein, an important molecule that has the potential to treat a broad spectrum of immunological diseases. We look forward to further progress in clinical studies of this biologic that could improve the lives of people with immune-mediated skin diseases."