ibudilast/bumetanide (STP1) / STALICLA - LARVOL DELTA

Stalicla Secures CHF 2 Million Financing Led by Addex Therapeutics to Advance Precision Medicine Neurodevelopmental Disorder Programs (GlobeNewswire) - "STALICLA SA...announced the successful closing of a CHF 2 million financing led by Addex Therapeutics. This financing will sustain operations and program development in neurodevelopmental disorders as Stalicla prepares for its upcoming Series C and the partnering of key programs. This financing underscores investor confidence in Stalicla’s innovative DEPI precision neuro platform and its portfolio of precision autism assets, STP1 and STP2. The company is also progressing its STP7 (mavoglurant) program, the most clinically advanced mGluR5 negative allosteric modulator, having concluded a Phase 3 enabling drug-drug interaction study in October 2024."

Financing • Autism Spectrum Disorder • CNS Disorders

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