selectION, Inc. Advances Lead Program for Treatment of T Cell Mediated Autoimmune Diseases to Clinical Development
– 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.
Atopic dermatitis (AD), also known as atopic eczema or neurodermatitis, is a multi-faceted, chronic, relapsing inflammatory skin condition commonly associated with other atopic manifestations such as food allergy, allergic rhinitis, and asthma. AD is the most common skin disease in children, affecting 15% to 20% of children and 1% to 3% of adults worldwide.
“We are pleased to initiate clinical development of si-544. The compound has the potential to transform the standard of care for T cell mediated autoimmune diseases such as atopic dermatitis, improving key aspects of efficacy and safety when compared to current clinical options,” said Antonius Schuh, Ph.D., Chairman and CEO of selectION, Inc.
About selectION, Inc.
selectION, Inc., is a clinical-stage biopharmaceutical company developing novel peptide therapies for autoimmune diseases and selected cancer indications by targeting autoreactive, chronically activated T cells.
The Company has established an efficient, unique technology platform to develop potent and highly selective peptide blockers for ion channels involved in various diseases. The platform enables to systematically optimize target selectivity, providing the opportunity to develop drugs with significantly improved efficacy and safety profiles.
selectION, Inc., is backed by SDL Ventures and Global Source Ventures. The Company is headquartered in San Diego, CA, USA, and has a subsidiary in Martinsried, Germany.
For further information, please visit https://selectiontherapeutics.com/
si-544, the Company´s clinical candidate, is blocking a specific ion channel involved in the activation and proliferation of TEM cells. TEM cells lie at the root of many autoimmune indications such as atopic dermatitis, psoriasis, rheumatoid arthritis or multiple sclerosis, but also of certain rare cancers like lymphomas.
si-544 has demonstrated excellent efficacy in animal and human T cell models.
The compound is a potent immuno-selective agent addressing a significant unmet medical need by functionally inhibiting and eliminating disease-specific, chronically activated TEM cells without compromising the protective immune response. Preclinical data suggest an excellent safety profile.