STALICLA initiates U.S. Phase 3 enabling DDI study of STP7 (Mavoglurant) to treat cocaine use disorder
May 02 2024 - 8:01AM
Geneva, Switzerland, May 2, 2024 – STALICLA SA,
a late-stage biotechnology company specializing in precision
medicine for brain disorders, announces the First Patient First
Visit (FPFV) for the company's drug-drug interaction (DDI) study of
STP7 (Mavoglurant), an mGluR5 negative allosteric modulator,
licensed to STALICLA by Novartis. The DDI study is the last
regulatory requirement in a comprehensive Phase 2 program and
completion is expected to trigger initiation of a Phase 3 study in
the U.S. in 2025.
Lynn Durham, CEO and Founder of STALICLA said,
“This DDI study unlocks the opportunity under our Cooperative
Research and Development Agreement with the U.S. NIH National
Institute of Drug Abuse (NIDA) to begin Phase 3 trials for STP7 in
2025 to address the high unmet medical need of cocaine abuse
globally. Results from successfully completed Phase 2 studies for
cocaine use disorder (CUD) showed highly convincing and
unprecedented efficacy results including increase in abstinence
from cocaine use and reduction in co-morbid dependencies such as
alcohol abuse with STP7 (Mavoglurant).In addition, STALICLA is
investigating alternative therapeutic indications for STP7
(Mavoglurant) to benefit patients with other CNS conditions.”
STP7 (Mavoglurant) is the most clinically
advanced negative allosteric modulator of the glutamate receptor 5
(mGluR5 NAM). As well as its role in addiction pathophysiology,
mGluR5 has been implicated in mood disorders and neurodevelopmental
disorders such as Fragile X and autism spectrum disorder.
Comprehensive clinical studies by Novartis of STP7 (Mavoglurant) to
date have included over 1800 adults for up to 2 years,
demonstrating good safety and tolerability and significant
reduction in cocaine use and positioning STP7 (Mavoglurant) as a
strong candidate therapy for substance use and other CNS
disorders.
STALICLA SA is a Swiss clinical-stage
biopharmaceutical company, pioneering precision treatment in
neurodevelopmental and neuropsychiatric disorders. Its AI-driven
precision neuro medicine platform has allowed to identify two
precision small molecule drug candidates for autism spectrum
disorder, STP1 and STP2, both planned to enter Phase 2 trials in
2024. Following the in-licensing of Mavoglurant from Novartis in
2023, STALICLA has also established an advanced mGluR5 NAM platform
offering multi-faceted late-stage clinical development
opportunities broadening STALICLA’s scope to address wider CNS
disease unmet needs. For more information, please visit:
www.stalicla.com.
For further information, please contact:
STALICLA SALynn DurhamFounder &
CEOlynn.durham@stalicla.com |
Chris MaggosCohesion Bureau+41 79 367 62
54chris.maggos@cohesionbureau.com |
- STALICLA PR DDI 02052024_final