SFX-01 will strengthen STALICLA's pipeline to advance precision medicine for a new subgroup of patient with Autism Spectrum Disorder
GENEVA, Oct. 10, 2022 /PRNewswire/ -- STALICLA S.A., a precision neuroscience clinical stage biotech, advancing the first precision medicine platform (DEPI) for patients with Neurodevelopmental Disorders (NDDs), today 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.
Key financial terms:
$0.5m upfront payment
Total cumulated milestones of up to $160.5m in relation to the first indication under the license.
Low to medium double digit percentage royalties on sales of SFX-01
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 / neuroscience.
With multiple clinical proof of concepts, DEPI has allowed for the identification of two distinct subgroups of patients with Autism Spectrum Disorder 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 DEPI platform has been validated in clinical setting showing high specificity, sensitivity and positive predictive value in prospectively designed trials recalling of "high" responder patients to previously failed drug candidates.
STALICLA is currently engaged in preparing its next stage of growth to advance its pipelines and to scale its platform towards revenue generation.
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About Evgen
Evgen Pharma is a clinical stage drug development company developing sulforaphane based medicines for the treatment of multiple diseases. The Company's core technology is Sulforadex®, a method for synthesising and stabilising the naturally occurring compound sulforaphane and novel proprietary analogues based on sulforaphane.
The Company's lead asset, SFX-01, is a patented composition of synthetic sulforaphane and alpha-cyclodextrin and has completed, with a positive outcome, a Phase 2a clinical trial for oestrogen-positive (ER+) metastatic breast cancer. In September 2021 the FDA granted Orphan Drug status to SFX-01 in malignant glioma.
The Company also has a wide number of collaborations with leading academic centres in the UK, Europe and AsiaPac as part of the continuing strategy to build the data set of safety and efficacy around the compound. With respect to non-core areas, Evgen signed an out-licensing deal with JuvLife, the dietary products and functional foods division of Juvenescence Ltd, for the development of a naturally sourced sulforaphane nutritional health supplement, stabilised using Evgen's Sulforadex® technology.
The Company has its headquarters and registered office at Alderley Park, Cheshire. It joined the AIM market of the London Stock Exchange in October 2015 and trades under the ticker symbol EVG.
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