TNP1

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 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. 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. ‎ The content above comes from the network. if any infringement, please contact us to modify.

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. The content above comes from the network. if any infringement, please contact us to modify.

Geneva, Switzerland, January 16th, 2024 – Stalicla SA, a clinical-stage biopharmaceutical company advancing precision medicine pipelines for neuropsychiatric and neurological disorders, announces the successful completion of the first closing of its Series B financing round, securing $17.4 million. Led by SPRIM Global Investments Pte, Ltd, with key participation from core investors, this funding includes a $3.8 million credit facility. The proceeds will be utilized for: (i) preparation of Stalicla’s pioneering precision Autism Spectrum Disorder (ASD) Phase 2 trial – STP1; (ii) the establishment of its STP7 mGluR5 Negative Allosteric Modulator (mGluR5 NAM) platform, including the launch a Phase III study in Substance Use Disorders (SUDs) slated for 2025, fully supported by the NIH /National Institute on Drug Abuse; (iii) the ramp up of its ongoing biosampling/ patient identification trial STA-B-001 currently enrolling in sites in the USA, Spain and Australia. Alongside these key developments, Stalicla will further strengthen the package supporting its second precision ASD asset, STP2. Lynn Durham, CEO of Stalicla commented: “This financial backing underscores Stalicla's role as a trailblazer in the neuro precision space with first applications in precision psychiatry. Additionally, our STP7 mGluR5 NAM platform is offering multifaceted advanced clinical development opportunities in the wider neurology space in a timely period of recent clinical progress & increased transaction activity level in the neurology and neuropsychiatry space. There has never been a more promising time to advance transformative treatment options for millions of patients with brain diseases and Stalicla is determined to play a key role in this progress.” To support these advancements, Stalicla will strengthen its Management Team and Board of Directors, reinforcing the foundation for the exciting journey ahead. About STALICLA SASTALICLA is a precision molecular neuroscience clinical stage company, advancing through its DEPI precision neuro platform 2 precision autism assets: STP1 and STP2. Following the in-licensing of mavoglurant from Novartis in 2023, STALICLA has also established an advanced mGLuR5 NAM platform with multi-faceted late-stage clinical development opportunities.For further information, please visit: https://stalicla.com/ Contact:Stalicla SALynn Durham, Founder & CEOLynn.durham@stalicla.com Attachment Press Release 2024-01-SeriesB_final