ibudilast/bumetanide (STP1) / STALICLA - LARVOL DELTA

Safety, Tolerability and Pharmacokinetics Study of STP1 in a Subgroup of Patients With Autism Spectrum Disorder (ASD) (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Stalicla SA | Phase classification: P1b ➔ P1

Phase classification • Autism Spectrum Disorder • Genetic Disorders

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. (PubMed, Biomedicines) - P1b | "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). Although numerical improvements were observed in several clinical scales, they did not reach statistical significance. Overall, this study suggests that STP1 is well-tolerated in ASD-Phen1 patients and shows indirect target engagement in ASD brain regions of interest."

Clinical • Journal • Autism Spectrum Disorder • Genetic Disorders

Characterization of a Clinically and Biologically Defined Subgroup of Patients with Autism Spectrum Disorder and Identification of a Tailored Combination Treatment. (PubMed, Biomedicines) - "Finally, the suitability of STP1 combination treatment to revert such observed molecular alterations in patients with ASD-Phen1 was determined. Overall, our results support the development of precision medicine-based treatments for patients diagnosed with ASD."

Journal • Autism Spectrum Disorder • CNS Disorders • Developmental Disorders • Genetic Disorders • Psychiatry

Safety, Tolerability and Pharmacokinetics Study of STP1 in a Subgroup of Patients With Autism Spectrum Disorder (clinicaltrials.gov) - P1b | N=12 | Completed | Sponsor: Stalicla SA | Recruiting ➔ Completed

Trial completion • Autism Spectrum Disorder • Genetic Disorders

Safety, Tolerability and Pharmacokinetics Study of STP1 in a Subgroup of Patients With Autism Spectrum Disorder (clinicaltrials.gov) - P1b; N=16; Recruiting; Sponsor: Stalicla SA; N=24 ➔ 16

Enrollment change • Autism Spectrum Disorder • Genetic Disorders

[VIRTUAL] STALICLA SA (BIO 2021) - "DEPI has reached clinical proof of concept with its first pipeline candidate, STP1, currently in clinical trials. STALICLA is advancing collaborative alliances with strategic third-party pipelines and is rapidly scaling its platform and clinical development activity to bring 2 pipelines in the clinic in 2022. To date STALICLA has raised $ 28 million and will be closing its series B in Q1 2022."

Safety, Tolerability and Pharmacokinetics Study of STP1 in a Subgroup of Patients With Autism Spectrum Disorder (clinicaltrials.gov) - P1b; N=24; Recruiting; Sponsor: Stalicla SA; Trial completion date: Apr 2021 ➔ Dec 2021; Trial primary completion date: Mar 2021 ➔ Nov 2021

Clinical • Trial completion date • Trial primary completion date • Autism Spectrum Disorder • Genetic Disorders

Safety, Tolerability and Pharmacokinetics Study of STP1 in a Subgroup of Patients With Autism Spectrum Disorder (clinicaltrials.gov) - P1b; N=24; Recruiting; Sponsor: Stalicla SA; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Autism Spectrum Disorder • Genetic Disorders

Safety, Tolerability and Pharmacokinetics Study of STP1 in a Subgroup of Patients (clinicaltrials.gov) - P1b; N=24; Not yet recruiting; Sponsor: Stalicla SA

Clinical • New P1 trial • Autism Spectrum Disorder • Genetic Disorders