STALICLA strengthens pipeline to advance precision medicine for Autism Spectrum Disorders

STALICLA's unique approach addresses a major weakness in the drug development process for Neurodevelopmental Disorders (NDDs) and neuropsychiatric disorders. Its unique approach is addressing the poor construct validity of behaviourally defined disorders through its proprietary DEPI platform, which integrates molecular data with human genetic information to create testable clinical hypotheses in psychiatry / 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 treatment STP1 and STP2 both planned to enter clinical Phase 2 in 2023. STP1 and STP2 hold a multi-billion market potential.

The addition of SFX-01 from Chesire-based Evgen Pharma plc (Evgen) will strengthen STALICLA's pipeline to advance precision medicine for a new subgroup of patient with ASD. 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.

"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", said Lynn Durham, STALICLA CEO & Founder.

"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. Evgen pHarma will receive $0.5m upfront payment, total cumulated milestones of up to $160.5m in relation to the first indication under the license and low to medium double digit percentage royalties on sales of SFX-01.

(Press release/RAN)