SelectION announces positive phase 1b results for lead compound in atopic dermatitis

Key takeaways:

• SelectION’s lead compound, si-544, was well tolerated up to the highest dose levels.
• 75% of patients saw disease improvement, 44% of which achieved clear or almost clear skin.

SelectION announced positive results from its first-in-human phase 1b trial of its lead compound, a selectively-optimized peptide, for the treatment of patients with atopic dermatitis, according to a company press release.

SelectION, a biopharmaceutical company developing treatments for T-cell mediated autoimmune diseases, has completed its phase 1b trial for si-544, a selectively-optimized peptide that blocks the ion channel Kv1.3.

Kv1.3 is a specific ion channel that is involved in the activation and proliferation of auto-reactive effector memory T cells, which cause many autoimmune diseases including atopic dermatitis, psoriasis and rheumatoid arthritis.

“So far, it has not been possible to block this ion channel with sufficient selectivity,” Andreas Klostermann, PhD, chief scientific officer and co-founder of selectION, said in the release. “To our knowledge, selectION is the first to achieve these important goals.”

The multi-center, double-blind, placebo-controlled phase 1b trial evaluated the safety, tolerability and efficacy signals of si-544 in patients with mild to severe atopic dermatitis.

Results showed that the drug was well tolerated up to the highest dose levels in both the single and multiple ascending dose cohorts. In fact, limits of safety and tolerability were not reached at the highest dose. Because of this, researchers did not determine the maximum tolerated dose.

Seventy five percent of patients experienced clinical improvement, 44% of which achieved clear or almost clear skin by the end of the study’s monitoring period. None of the patients reduced their dosage or discontinued due to adverse events. No serious adverse events were reported.

“Based on the results of this first clinical trial, we believe that si-544 has the potential to set a new benchmark for safety and tolerability in the treatment of T-cell autoimmunity,” Antonius Schuh, PhD, chairman and CEO of selectION, said in the release. “We are now planning to advance si-544 through clinical development and evaluate the compound in further autoimmune diseases.”