STALICLA and Firefly Neuroscience enter Partnership Agreement for the Development of Electroencephalogram (EEG) as a Biomarker for Subgroups of Patients with ASD

The combination of STALICLA and Firefly Neurosciences’s machine learning platforms and know-how will further strengthen the development of precision medicine for these patients

Geneva, Switzerland – 27 March 2023, STALICLA SA and Firefly Neuroscience today announced a partnership to further validate EEG-based biomarkers in biologically enriched subgroups of patients with Autism Spectrum Disorder (ASD). This follows the successful completion of STALICLA’s Phase 1b clinical trial for its lead asset STP1 where EEG measurement was shown to be a powerful predictor of efficacy.

STALICLA and Firefly Neuroscience will leverage their technological platforms including the Databased Endophenotyping Patient Identification (DEPI) platform and the FDA-cleared Brain Network Analytics (BNA™) platform respectively to further advance EEG validation in two upcoming Phase 2 clinical trials, sponsored by STALICLA.

Applying BNA™ to the DEPI-driven biologically enriched subgroups of patients with ASD is expected to establish and expand EEG as a biomarker in the field of ASD. EEG measurements will reinforce the DEPI stratification capacity and prediction of treatment response in patients with a behavioral diagnosis of ASD.

STP1 is a tailored treatment candidate for ASD-Phenotype 1, the first DEPI-enriched subgroup of patients. STP1 positive target engagement was demonstrated by specific EEG signal modulation in brain areas of interest.

Lynn Durham, STALICLA’s CEO & Founder, commented: “STALICLA is thrilled to partner with Firefly Neuroscience to advance an EEG-based treatment response marker in the NDD population. STALICLA will leverage its DEPI platform and Firefly Neuroscience’s technology to reinforce its leadership in precision medicine for neurodevelopmental disorders with rapid implementation of precision EEG in our upcoming two phase 2 programs in Autism Spectrum Disorder.”

Jon Olsen, Firefly Neuroscience’s CEO, commented: “Firefly Neuroscience is excited to partner with STALICLA on the advancement of treatment for people with ASD. Using BNA™ to target sub-groups of patients for precision medicine treatment in the CNS space is a core focus for the company. The fact that BNA™ is FDA cleared and used by clinicians in the United States to support therapy decisions for people with mental disorders puts us in a very strong position to build a referral network in support of the commercialization of novel drugs and therapies for the treatment of NDD diseases.”

STALICLA has developed and validated a machine learning platform, DEPI, allowing ASD subgroup identification and precision medicine treatment candidate selection. With multiple clinical proof of concepts, DEPI has allowed for the identification of two distinct subgroups of patients with ASD and their tailored treatments STP1 and STP2. Both STP1 and STP2 are planned to enter Phase 2 clinical trials in 2023.

Firefly Neuroscience’s BNA™ platform is a patented technology that provides an objective, quantified assessment of cognition (brain function). It measures brain function and compares it to an FDA-cleared, normative, age-matched database using proprietary AI and advanced signal processing technology. Firefly Neuroscience’s AI platform (‘Fly-AI’) will help develop future biomarkers and companion diagnostics allowing for the expansion of existing pharma collaborations and partnerships to make the development of new CNS drugs more efficient.

About STALICLA
STALICLA is a precision molecular neuroscience clinical stage biotech company, advancing the first precision medicine platform (DEPI) for patients with neurodevelopmental disorders (NDDs), and neuropsychiatric disorders.
STALICLA’s unique approach is addressing the poor construct validity of behaviourally defined disorders through its unique platform integrating molecular data with human genetic information to create testable clinical hypotheses in psychiatry and neuroscience.
With multiple clinical proof of concepts, DEPI has allowed for the identification of two distinct subgroups of patients with Autism Spectrum Disorder (ASD) and their tailored treatments STP1 and STP2, both of which are planned to enter Phase 2 clinical trials in 2023. STP1 and STP2 hold a multi-billion market potential.
The DEPI platform has been validated in a clinical setting showing high specificity, sensitivity and positive predictive value in prospectively designed trials recalling ‘high’ responder patients to previously failed drug candidates.
STALICLA is currently preparing its next stage of growth to advance its pipelines and scale its platform.

For further information, please visit: https://stalicla.com/

About Firefly Neuroscience
Firefly Neuroscience leverages technical advances in computing and AI to deconstruct, analyze, and compare electroencephalograms (EEG), making them clinically useful for front-line clinicians to objectively measure, monitor, and manage brain function. Building on over a decade of research, the product has received FDA clearance and is commercially used in American clinics since mid-2022.
With BNA™, clinicians and their patients can now make informed, objective therapy and disease management decisions, track changes over time and improve therapy compliance. It takes the guesswork and subjectivity out of managing mental illnesses and cognitive disorders- as one can only effectively manage what can accurately be measured.
Firefly Neuroscience’s AI platform (‘Fly-AI’) has been built to develop future biomarkers and companion diagnostics (pharma) allowing for the expansion of existing pharma collaborations to bring new drugs to market. It has been used with leading companies such as Novartis, Takeda, and Purdue and is poised to revolutionize the required objective measurement for effective CNS drug development.

For further information, please visit: https://fireflyneuro.com

   Contacts

STALICLA SA Lynn Durham, Founder & CEO Lynn.durham@stalicla.com Firefly Neuroscience Jon Olsen, CEO Jon.olsen@fireflyneuro.com Media inquiries Consilium Strategic Communications stalicla@consilium-comms.com