STALICLA publishes pioneering phase 1b data on precision treatment for autism spectrum disorder in Biomedicines
June 27 2024 - 7:10AM
Press Release
STALICLA’s precision psychiatry study highlights
strong EEG-based target engagement of STP1 treatment in defined
subgroup of patients with autism and numerical improvement in core
symptoms
Geneva, Switzerland – June 27, 2024 – STALICLA
SA, a Swiss neuro precision biotech company dedicated to developing
precision medicine-based treatments for neuropsychiatric and
neurodevelopmental disorders, today announced the publication of a
landmark phase 1b study with STP1, a novel combination therapy
tailored for the treatment of a clinically and biologically defined
subgroup of patients with autism spectrum disorder (ASD), named ASD
Phenotype 1 (ASD-Phen1).
The results of the study were published in the peer-reviewed
journal Biomedicines, in an article titled “Safety, Tolerability,
and EEG-Based Target Engagement of STP1 (PDE3,4 Inhibitor and NKCC1
Antagonist) in a Randomized Clinical Trial in a Subgroup of
Patients with ASD”.
Lynn Durham, CEO of STALICLA, highlighted:
“This study marks a significant milestone in the advancement of
precision medicine for ASD. It is a first-of-its-kind
stratification-based approach for clinical development in
neurodevelopmental disorders, demonstrating the potential of
precision medicine in ASD.”
The randomized, double-blind, placebo-controlled phase
1b clinical trial evaluated the safety and tolerability of
STP1, a combination of ibudilast and bumetanide, in ASD-Phen1
patients. The clinical trial (registered at clinicaltrials.gov
NCT04644003), involved two 14-day treatment phases of ASD-Phen1
patients receiving STP1 or placebo.
The results showed that STP1 was well-tolerated with no
significant adverse effects reported. Significant
and dose-related reductions in gamma power were observed
in the whole brains of patients taking STP1, particularly in
regions associated with executive function and memory.
Additionally, STP1 increased alpha 2 power in frontal and occipital
regions, while improving habituation and neural synchronization to
auditory chirps.
Dr. Craig A. Erickson, Associate Professor, UC
Department of Psychiatry and Behavioral Neuroscience, Cincinnati
Children’s Hospital Medical Center, and the principal investigator
of the study, remarked: “The electrophysiological signals
from this study are remarkable and represent the strongest early
trial target engagement signals our lab has seen in the autism
field.”
Dr. Laura Pérez-Cano, Head of Discovery at
STALICLA and co-author of the study, added: “These
findings not only highlight the potential of STP1 as a therapeutic
option for ASD-Phen1 patients but also underscore the importance of
combining biologically-based patient stratification with
quantifiable outcome measures such as EEG that can then be
correlated with behavioral measures.”
By focusing on a biologically defined subgroup of ASD patients,
STALICLA is moving closer to making personalized treatment options
a reality for patients with ASD. This approach has the potential to
revolutionize the treatment of ASD and other neuropsychiatric
conditions.
For the full article in Biomedicines click
here.
About STALICLA:STALICLA is a global,
clinical-stage biotechnology company focused on advancing precision
medicine for brain disorders.
The company has developed a unique neuro precision development
platform, DEPI, supported by clinical validation in a first
indication: Autism Spectrum Disorder. Its lead neurodevelopmental
disorder asset, STP1, is entering Phase 2 trials.
Its lead neuropsychiatry asset, STP7 (Mavoglurant), fully funded
by the US government, will soon be Phase 3 ready for Cocaine Use
Disorder.
For more information, please visit:
www.stalicla.com.
Contact:STALICLA SALynn Durham, Founder &
CEOlynn.durham@stalicla.com
Chris MaggosCohesion Bureauchris.maggos@cohesionbureau.com
- Press_release_STP1_Phase1b_Final