si-544 Phase 1b trial in psoriasis

[Fred]

si-544 has demonstrated an excellent safety and tolerability profile in two completed Phase 1b clinical trials in atopic dermatitis patients and, more recently, in psoriasis.

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selectION, Inc a clinical-stage biopharmaceutical company developing novel treatments for T cell-mediated autoimmune diseases, today announced the successful completion of its phase 1b proof-of-concept trial evaluating si-544, a first-in-class Kv1.3 blocker in patients diagnosed with psoriasis vulgaris.

“These results mark a significant milestone, as si-544 has, for the first time, clinically confirmed the long hypothesized and remarkable therapeutic potential of Kv1.3 in T cell autoimmunity,” said Antonius Schuh, Ph.D., CEO of selectION. “This trial clinically validates Kv1.3 dependency as an ideal clinical entry point to disrupt the chronic activation of pathogenic, autoreactive T cells. si-544 has the potential to become a disease modifying and safe treatment option, offering meaningful and durable reduction of disease burden across a broad spectrum of T cell-mediated autoimmune diseases.”

This Phase 1b study was a randomized, double-blind, placebo-controlled proof-of-concept trial in patients diagnosed with mild-to-severe psoriasis vulgaris. Patients received 2 subcutaneous injections of si-544 or placebo (ratio 3:1) per week over a period of 4 weeks and were monitored for a period of 12 weeks post drug washout.

The trial enrolled 45 patients across four clinical sites in Germany. Its primary objective was to evaluate the safety and tolerability of si-544, including monitoring adverse events, laboratory and ECG findings, and vital signs. Secondary endpoints included pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy across key dermatologic measures, including psoriasis area and severity index (PASI), physician’s global assessment (PGA), and body surface area (BSA).

Key findings:

• si-544 was well tolerated with no related serious adverse effects, dose-limiting toxicities, or safety signals observed
  
• A short 4-week treatment cycle resulted in significant clinical improvement as measured by change in Psoriasis Activity and Severity Index (PASI)
  
• Signs of clinical efficacy were seen as early as week 2 of the treatment period
  
• Disease stabilization and continued healing were observed over the entire 12-week monitoring period, post drug washout
  
• Patients treated with si-544 maintained full immunocompetence
  

Source: selectiontherapeutics.com