Phase 1b trial is designed to evaluate safety, tolerability, and efficacy of potent Kv1.3 blocker in T-cell mediated autoimmunity
– San Diego, CA, USA, and Munich, Germany – September 12, 2022 – selectION, Inc., a clinical-stage biopharmaceutical company developing novel peptide therapies for the treatment of T-cell mediated autoimmune diseases and rare lymphomas, today announced that the Company has begun dosing patients in a Phase 1b trial to evaluate safety and efficacy, including duration of clinical benefit, of si-544 in patients with mild to severe atopic dermatitis. si-544 is a high-affinity Kv1.3-blocking peptide with class-leading selectivity. Pre-clinical data demonstrate an excellent safety profile with fully maintained immunocompetence, and high biological activity.
Kv1.3 dependency is an exclusive and defining feature of chronically activated, disease-associated effector memory T (TEM) cells. Chronically activated TEM cells are the drivers of 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, Kv1.3 dependent TEM cells. Kv1.3 blockage interrupts activation and terminates proliferation of such chronically activated TEM cells.
A potent and highly selective Kv1.3 blocker such as si-544 is expected to deliver high clinical response rates and long-lasting clinical benefit. Importantly, si-544 exclusively targets disease-associated TEM cells and otherwise spares the immune system, leaving the patient fully immuno-competent when under treatment – a critical safety advantage compared to other treatment options for autoimmunity.
This 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.
“We are excited to conduct this information rich clinical trial of si-544, and to demonstrate for the first time in humans, that a highly selective Kv1.3 blocker can achieve plasma levels sufficient to result in high target engagement and meaningful relief while maintaining full immunocompetence in the patient” said Andreas Klostermann, PhD, Chief Scientific Officer and co-founder of the Company.
“Advancing si-544 into clinical development is a significant achievement for selectION, Inc. and an important milestone in the development of immune-selective therapies that have the potential to change the standard of care, for millions of patients in need“ said Antonius Schuh, PhD, 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 supported 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 Kv1.3, 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.
Dr. Ludger Wess / Ines-Regina Buth
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Steve Zaniboni (CFO)
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