selectION Announces Positive Results from Phase 1b Clinical Trial Evaluating si-544 in Patients with Atopic Dermatitis
April 29 2024 - 4:00AM
- si-544 was well tolerated with no serious adverse
effects, dose limiting toxicities, or safety signals
observed
- 75% of patients receiving si-544 experienced objective
clinical improvement, of which 44% achieved clear or almost clear
skin
San Diego, CA, USA, and Munich, Germany – April
29, 2024 - selectION, Inc., a clinical-stage biopharmaceutical
company developing novel treatments for T-cell mediated autoimmune
diseases, today announced positive results from the first-in-human
Phase 1b trial of its lead compound, si-544, in atopic dermatitis
patients. si-544 is a selectivity-optimized peptide blocking the
ion channel Kv1.3.
The completed Phase 1b trial was a multi-center,
double-blind, placebo-controlled study in patients with mild to
severe atopic dermatitis. The trial was designed to evaluate
safety, tolerability, and efficacy signals of si-544.
si-544 was well tolerated up to the highest dose
levels in the single ascending dose cohorts (s.c.) and in the
multiple ascending dose cohorts (s.c.). Safety signals or dose
limiting toxicities were not observed. Of note, limits of safety
and tolerability were not reached at the highest doses administered
in the study, therefore the maximum tolerated dose was not
determined. There were no serious adverse events and no dose
reductions or temporary / permanent discontinuations of dosing due
to adverse events.
75% of patients receiving drug experienced
objective clinical improvement, and of these patients, 44% achieved
clear or almost clear skin at the end of the monitoring period. The
healing trend clearly continued beyond dosing through the entire
monitoring period.
“The ion channel Kv1.3 controls the activation
and proliferation of auto-reactive effector memory T-cells and has
been regarded a key target in T-cell autoimmunity for decades,"
said Andreas Klostermann, PhD, Chief Scientific Officer and
co-founder of the Company. "So far, it has not been possible to
block this ion channel with sufficient selectivity. The initial
analysis of safety and tolerability data from 27 patients in the
SAD and MAD cohorts confirms that si-544 can be safely administered
at dose levels sufficient to achieve virtually full Kv1.3 target
engagement. It also demonstrates that our high-affinity
Kv1.3-blocking peptide, si-544, has class-leading selectivity. To
our knowledge, selectION is the first to achieve these important
goals.”
“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," said Antonius Schuh, PhD, Chairman and CEO of
selectION, Inc. "Study results indicate a clear initial efficacy
signal. In addition, under continuous dosing no indication of
immunosuppression has been observed. We are now planning to advance
si-544 through clinical development and evaluate the compound in
further autoimmune diseases.”
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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 systematically optimized 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, with a clinical R&D subsidiary in
Munich/Martinsried, Germany.
For further information, please visit
https://selectiontherapeutics.com/
About si-544si-544, the Company´s lead
drug candidate, is blocking Kv1.3, a specific ion channel involved
in the activation and proliferation of TEM cells, with what we
believe to be class leading selectivity. 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 an excellent safety and
tolerability profile in a recently completed Phase 1b clinical
trial in atopic dermatitis patients, with study results also
indicating a clear initial efficacy signal. Previously, 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 while maintaining full immunocompetence.
Forward Looking StatementsThis
press release includes forward-looking statements related to
selectION, Inc. (the “Company”), including statements regarding the
prospects of si-544 and the value of the phase 1b trial evaluating
si-544 in patients with atopic dermatitis (the “Trial”). These
forward-looking statements are based upon information that is
currently available to the Company and its current expectations,
speak only as of the date hereof, and are subject to risks and
uncertainties that could cause actual results to differ materially
from those projected, including risks that the Company does not
realize the expected benefits of si-544 or the Trial; risks that
the results of the Trial may not be accurate; risks that prior
clinical trial results may not be repeated; and general economic
and market factors. Any of these may cause the Company’s actual
results, performance, or achievements to differ materially and
adversely from those anticipated or implied by the Company’s
forward-looking statements. The Company expressly disclaims any
obligation, except as required by law, or undertaking to update or
revise any such forward-looking statements.
Contacts
Media Contact: akampionDr. Ludger Wess / Ines-Regina Buth
Managing Partnersinfo@akampion.comT: +49 40 88 16 59 64 /T: +49 30
23 63 27 68
Investor Contact:selectION, Inc.Steve Zaniboni Chief Financial
Officerszaniboni@selectiontherapeutics.comT: +1 858 967 8014