- Novel ion channel blocker designed to combine high efficacy and durable response while maintaining full immune system functionality
San Diego, CA, USA, and Munich, Germany – May 9, 2022 - selectION, Inc., a biopharmaceutical company developing novel peptide therapies for the treatment of T cell mediated autoimmune diseases and rare lymphomas, today announced that Germany´s regulatory agency has authorized the Company’s clinical trial application for a Phase 1b trial evaluating the safety and efficacy of selectION´s clinical candidate, si-544, in patients diagnosed with mild to severe atopic dermatitis.
si-544 selectively blocks Kv1.3, an ion channel essential for the chronic activation and proliferation of disease-associated effector memory T (TEM) cells. Chronically activated TEM cells drive inflammation in many autoimmune diseases, including atopic dermatitis, psoriasis, rheumatoid arthritis, and multiple sclerosis. In certain rare lymphomas, the tumor mass is comprised of malignant TEM cells.
This unique mode of action is expected to deliver high response rates and long-lasting clinical benefit. si-544 exclusively targets disease-associated TEM cells and otherwise spares the immune system, leaving the patient fully immuno-competent - a critical safety advantage compared to other treatment options for autoimmunity.
si-544 has demonstrated strong efficacy in animal and human T cell disease models and - for the first time - integrates high ion channel affinity with optimized blocking selectivity. Based on preclinical safety and tolerability data, the Company expects an excellent clinical safety profile for si-544.
The initial clinical study is designed as a multi-center, Phase 1b, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and efficacy of si-544 in adults with mild to severe atopic dermatitis. The primary endpoints of the trial are safety and tolerability; secondary endpoints include pharmacokinetics and pharmacodynamics. The approved trial design also provides the possibility to evaluate efficacy signals and an initial assessment of duration of clinical response.
“There is significant precedent for the efficacy of Kv1.3 blockers in TEM cell mediated autoimmune diseases like atopic dermatitis. Based on our preclinical data package, we are confident that si-544 may be the first ion channel blocker combining high target affinity with high selectivity for a clinically enabling therapeutic window,” said Andreas Klostermann, Ph.D., Chief Scientific Officer and co-founder of the Company.