selectION Begins Phase 1b Trial for si-544 in Psoriasis and Psoriatic Arthritis

7 June 2024

selectION, Inc., a clinical-stage biopharmaceutical company, announced the launch of a Phase 1b trial for its leading compound, si-544, targeting psoriasis vulgaris (Ps) and psoriatic arthritis (PsA) in adults. si-544 is a peptide designed to block the Kv1.3 ion channel, which is critical in T cell-mediated autoimmune diseases. By optimizing selectivity, the company anticipates si-544 will offer a new standard for safety and tolerability in treating these conditions. Patient recruitment is ongoing, and initial results are expected by the fourth quarter of 2024.

This new trial is a multicenter, double-blind, placebo-controlled study aimed at adults with mild to severe Ps or PsA. selectION plans to enroll up to 40 patients, including up to 16 who may have PsA. This study follows the completion of a similar Phase 1b trial for atopic dermatitis, which demonstrated the safety and tolerability of si-544. The current study aims to further investigate efficacy signals alongside its primary endpoints of safety and tolerability. Participants will undergo a 4-week treatment period followed by a 12-week follow-up.

In addition to safety and tolerability, the trial will evaluate secondary endpoints such as inflammatory cytokine levels. Dr. Andreas Klostermann, Chief Scientific Officer and co-founder of selectION, emphasized the company's commitment to expanding the clinical development of si-544 in autoimmune diseases. Dr. Antonius Schuh, Chairman and CEO, highlighted the encouraging results from the atopic dermatitis study, reinforcing the potential of Kv1.3 inhibition for treating various autoimmune conditions.

selectION, Inc. specializes in developing novel peptide therapies for autoimmune diseases and certain cancers by targeting autoreactive, chronically activated T cells. The company’s unique technology platform focuses on developing highly selective peptide blockers for ion channels involved in various diseases. This platform aims to create drugs with improved efficacy and safety profiles. selectION is headquartered in San Diego, California, with a research and development subsidiary in Munich/Martinsried, Germany.

si-544, the company’s leading drug candidate, targets the Kv1.3 ion channel, which is pivotal in the activation and proliferation of TEM cells. These cells are implicated in many autoimmune conditions such as atopic dermatitis, psoriasis, rheumatoid arthritis, multiple sclerosis, and certain rare cancers like lymphomas. si-544 has shown promising safety and tolerability in a recently completed Phase 1b trial for atopic dermatitis, with initial indications of efficacy. Previous studies in animal and human T cell models have also demonstrated excellent efficacy.

The compound aims to address significant unmet medical needs by inhibiting and eliminating disease-specific, chronically activated TEM cells while preserving overall immune function. selectION believes si-544's selectivity and potency could set a new benchmark in the treatment of autoimmune diseases.

The company’s technology platform offers the potential for systematically optimized target selectivity, paving the way for the development of drugs with significantly improved efficacy and safety attributes. selectION is backed by SDL Ventures and Global Source Ventures.

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