Delving into the Latest Updates on SI-544 with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

SI 544, SI-544

Target

Kv1.3

Action

blockers

Mechanism

Kv1.3 blockers(Voltage-gated potassium channel subunit Kv1.3 blockers)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesSkin and Musculoskeletal Diseases+ [4]

Active Indication

Arthritis, PsoriaticPsoriasis vulgarisDiabetes Mellitus, Type 1+ [5]

Inactive Indication

Cutaneous T-Cell LymphomaDermatitis, Atopic

Originator Organization

selectION, Inc.

Active Organization

selectION, Inc.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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The main objective of this study is to investigate the safety and tolerability of si-544.
Other objectives are to study the metabolism of si-544 in the body and to assess the effects of si-544 on cells of the body's immune system (immune cells) that have been chronically activated by the disease. Likewise, the effect of si-544 on inflammatory responses in the body triggered by the disease and other disease symptoms will be investigated.

Start Date22 Jan 2024

Sponsor / Collaborator

selectION, Inc.

[+1]

NCT05383378

/ CompletedPhase 1

A Multi-center, Phase 1b, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Efficacy of Si-544 in Adults With Atopic Dermatitis

This is a multi-center, Phase 1b, double-blind, placebo-controlled, SAD and MAD, first-in-human study in subjects with mild to severe AD receiving si-544. The study consists of 2 parts, an SAD and an MAD part. In both parts, subjects will be treated in cohorts and will be randomized within each cohort to treatment with si-544 or placebo. Initially, 2 sentinel subjects will be treated (randomized to placebo or si-544) in each cohort.

Start Date30 Aug 2022

Sponsor / Collaborator

selectION, Inc.

[+1]

100 Clinical Results associated with SI-544

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100 Translational Medicine associated with SI-544

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100 Patents (Medical) associated with SI-544

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7

News (Medical) associated with SI-544

12 May 2026

·selectiontherapeutics.com

Meet selectION, Inc. at the BIO International Convention in San Diego, CA, on June 22nd-25th, 2026

SAN DIEGO, May 12, 2026 – Meet selectION’s management team for an update on si-544, selectION’s best-in-class Kv1.3 ion channel blocker in development as a disease-modifying treatment for T cell-mediated autoimmune diseases. selectION recently completed Phase 1b clinical trials in patients with atopic dermatitis and psoriasis, demonstrating excellent safety, tolerability, and early efficacy signals. Further details regarding the Company’s clinical progress and planned Phase 2 development strategy will be discussed during partnering sessions.

Phase 1Phase 2

12 Dec 2025

·selectiontherapeutics.com

Meet selectION, Inc. at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, CA, on January 12th-15th, 2026

SAN DIEGO, Dec 12, 2025 – Meet selectION’s management team for an update on selectION’s best-in-class Kv1.3 ion channel blocker, si-544, for the disease modifying treatment of T cell-mediated autoimmunity. selectION successfully completed Phase 1b clinical trials in atopic dermatitis and psoriasis patients, demonstrating excellent safety, tolerability and early efficacy signals. Currently selectION is planning subsequent Phase 2 studies.

Phase 1Phase 2

26 May 2025

·selectiontherapeutics.com

Meet selectION, Inc. at BIO International Convention in Boston,MA, on June 16th-19th, 2025

SAN DIEGO, May 26, 2025 – Meet selectION’s management team for an update on selectION’s best-in-class Kv1.3 ion channel blocker for the treatment of T-cell mediated autoimmunity while maintaining the patients’ full immunocompetence. selectION successfully completed its first-in-human study with si-544 in atopic dermatitis patients, demonstrating excellent safety, tolerability and early efficacy signals. The currently ongoing Phase1b study in psoriasis patients is expected to be completed in Q3 2025, and is designed to evaluate efficacy at high dose level in preparation of subsequent Phase 2 studies.

100 Deals associated with SI-544

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Arthritis, Psoriatic	Phase 1	Germany	selectION, Inc.	22 Jan 2024
Psoriasis vulgaris	Phase 1	Germany	selectION, Inc.	22 Jan 2024
Dermatitis, Atopic	Phase 1	Germany	selectION, Inc.	30 Aug 2022
Diabetes Mellitus, Type 1	Preclinical	United States	selectION, Inc.	01 May 2026
Hidradenitis Suppurativa	Preclinical	United States	selectION, Inc.	01 May 2026
Inflammatory Bowel Diseases	Preclinical	United States	selectION, Inc.	01 May 2026
Alopecia Areata	Preclinical	United States	selectION, Inc.	01 Dec 2025
Nonsegmental vitiligo	Preclinical	United States	selectION, Inc.	01 Dec 2025
Vasculitis	Preclinical	United States	selectION, Inc.	01 Dec 2025
Cutaneous T-Cell Lymphoma	Preclinical	Germany	selectION, Inc.	01 Sep 2025

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Biosimilar

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