STALICLA to in-license SFX-01 from Evgen for neurodevelopmental disorder indications

STALICLA SA, a precision neuroscience clinical stage biotech, advancing the first precision medicine platform (DEPI) for patients with Neurodevelopmental Disorders (NDDs), announced the worldwide in-licensing of SFX-01 from Evgen Pharma plc (Evgen) in neurodevelopmental disorders and schizophrenia, with a first indication for a biologically-characterized subgroup of patients with Autism Spectrum Disorder (ASD).

STALICLA’s unique approach addresses a major weakness in the drug development process for NDDs and neuropsychiatric disorders: behaviour is a terrible biomarker. Thanks to DEPI, a proprietary platform aggregating molecular data and human genetic information, STALICLA pushes the frontier of precision medicine further into precision NDDs. DEPI has already reached validation through the clinical identification of biologically defined subgroups of patients with ASD, and their respective candidate treatments. SFX-01 will strengthen STALICLA’s pipeline to advance precision medicine for a new subgroup of patient with Autism Spectrum Disorder.

SFX-01 is a patented composition of sulforaphane and alpha cyclodextrin, and the only grade of sulforaphane suitable for clinical research and possible approval as medicine. Thanks to DEPI, STALICLA identified SFX-01 as the best treatment candidate for its second subgroup of patients, ASD-Phenotype 2. SFX-01 in-licensing follows the completion, in early 2022, of Phase 1b for STP1, Stalicla’s lead candidate tailored to ASD-Phenotype1, a first subgroup of patients identified by DEPI.

Lynn Durham, STALICLA CEO & Founder commented: “There are no current approved treatments for ASD. Bringing precision treatments to patients such as SFX-01 could radically alter this landscape thanks to an effective oral option for a subgroup of ASD patients. This agreement with Evgen to advance SFX-01 expands STALICLA’s option to improve the quality of life of a biologically defined subgroup of patients with ASD“.

Dr Huw Jones, Evgen CEO, added: “Stalicla is a unique partner in the ASD space, with its proprietary technology for screening those patients who are most likely to respond to SFX-01. This recognition of SFX-01 as a potential treatment for a major neuropsychiatric condition, demonstrates the variety of potential uses of our Sulforadex® stabilising platform, along with our ability to execute on our business model.”

Pursuant to the terms of the agreement, STALICLA will be responsible for the clinical development in the NDD field, and the parties will cooperate on regulatory activities to secure approval of the product.