Thursday, August 22, 2019
STALICLA announces completion of pre-IND meeting with FDA on STP1 for subgroup of patients with Autism Spectrum Disorder (ASD)
Geneva, Switzerland. August 22nd, 2019 - STALICLA, a Swiss Biotech company, today announced the completion of its pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) on the preparation for entry of STP1 into clinical trials.
“We are appreciative of FDA´s technical guidance and strong interest in personalized medicine approaches for patients with Autism Spectrum Disorder. STALICLA is committed to rapidly move forward with the submission of its STP1 IND. STP1 holds the potential to become the first precision medicine for a subgroup of patients with ASD, and herald a new age for this field.”
- Lynn Durham, CEO and Founder of STALICLA.
ASD is a common neurodevelopmental disorder, with high level of heterogeneity, that affects 1 in 59 8-year-old school children in the U.S. (CDC, 2018). Eighty percent of patients are still considered idiopathic (without a genetically identifiable cause). Traditionally, drug developers have approached ASD as a single-disease entity, overlooking its clinical complexity and biological heterogeneity.
STP1 has been developed using STALICLA´s innovative systems biology-driven platform (DEPI), which is an integrative framework that uses large-scale genetic, molecular, pharmacological and clinical data to define patient subgroups in ASD and to identify personalized treatments. This is the first time that such technologies have been utilized within the field of neurodevelopment, and it is a hugely exciting project with scope to change the direction of this speciality.
STALICLA will submit its STP1 IND to enter a Phase 1b clinical trial.
The First ‘Phenotype 1’ ASD patients will be enrolled in early 2020.
STALICLA is a near clinical Swiss Biotech Company developing a unique approach to bring personalized medicine to patients with ASD. Today, patients with ASD account for approximately 1.5% of the world’s population, and the condition remains a high unmet medical need.
In its Geneva and Barcelona units, STALICLA has assembled world-class teams of experienced drug developers and computational biologists. The Company is recognized as a disruptive player, using its systems biology DEPI platform to identify subgroups of patients with ASD and candidate repurposed and rescued drugs. Patients are then characterized through biomarker preclinical and clinical investigations. This translates into a derisked drug development process bringing the vision of ASD personalized medicine to reality.
STALICLA’s first investigational precision medicine - STP1 - addresses a distinct subgroup of ASD patients estimated to 2 million people in Europe and North America. To support STP1’s development and create strong value for all stakeholders, STALICLA has developed a network of top-tier research and clinical partners and established IP as a strategic priority. STALICLA is currently applying its DEPI discovery model to characterize additional subgroups of patients and advance new pipelines. Applicability of the DEPI platform goes beyond ASD and has potential for drug discovery in other complex ill-defined diseases.