Health AI Central
Peer-Reviewed Publication
Biomedicines2024;12(7)June 27, 2024Journal Article

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.

Craig A Erickson1,2, Laura Perez-Cano3, Ernest V Pedapati1,2,4, Eric Painbeni5, Gregory Bonfils5, Lauren M Schmitt6,7, Hannah Sachs1, Meredith Nelson6, Lisa De Stefano6, Grace Westerkamp1, Adriano L S de Souza5, Oliver Pohl5, Offir Laufer8, Gil Issachar8, Thomas Blaettler5, Jean-Marc Hyvelin5, Lynn A Durham5
1Division of Child and Adolescent Psychiatry, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA.
2Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati, Cincinnati, OH 45229, USA.
3Discovery and Data Science (DDS) Unit, STALICLA SL, Moll de Barcelona, s/n, Edif Este, 08039 Barcelona, Spain.
4Division of Child Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA.
5Drug Development Unit (DDU), STALICLA SA, Campus Biotech Innovation Park, Avenue de Sécheron 15, 1202 Geneva, Switzerland.
6Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA.
7Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH 45229, USA.
8Firefly Neuroscience, Herzliya 4672501, Israel.
PubMed PMC DOI PDF

Abstract

This study aimed to evaluate the safety and tolerability of STP1, a combination of ibudilast and bumetanide, tailored for the treatment of a clinically and biologically defined subgroup of patients with Autism Spectrum Disorder (ASD), namely ASD Phenotype 1 (ASD-Phen1). We conducted a randomized, double-blind, placebo-controlled, parallel-group phase 1b study with two 14-day treatment phases (regi…

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