STALICLA completes pre-IND meet with FDA on STP1 for patients with ASD

• Atrium Spectrum Disorder (ASD) affects 1 in 59 school children of 8-years in the United States. It is a common neurodevelopmental disorder, with a higher level of heterogeneity.
   
• Such technologies are used for the first time in the neurodevelopment field and it is a hugely thrilling project with a scope to change path of this specialty.

STALICLA, a biotech company focused on Autism Spectrum Disorder (ASD) based in Switzerland, reportedly announced the completion of pre-Investigational New Drug (IND) meeting with the United States Food and Drug Administration (FDA) about the preparation for the entry of STP1 into clinical trials.

CEO and Founder of STALICLA, Lynn Durham stated that the company is appreciative of strong interest and technical guidance given by FDA in personalized medicine approaches for Autism Spectrum Disorder (ASD) patients.

Durham added that STALICLA is focused to rapidly move ahead with the submission of STP1 Investigational New Drug (IND). STP1 has the potential to be the first precision medicine for a patient subgroup having Autism Spectrum Disorder and thus herald a new future for this field.

ASD affects 1 in 59 school children of 8-years in the United States. It is a common neurodevelopmental disorder, with a higher level of heterogeneity. Eighty percent of patients are considered as idiopathic, with no genetically identifiable cause. Conventionally, drug developers have seen ASD as a single-disease entity, overseeing its biological heterogeneity and clinical complexity.

STP1 is developed by utilizing STALICLA’s systems biology driven platform; DEPI, an integrative framework that utilizes large-scale clinical, pharmacological, molecular and genetic data to define patient subgroups in Autism Spectrum Disorder and to select personalized treatments.

Such technologies are being used for the first time in the neurodevelopment field, and it is a hugely thrilling project with a scope to change path of the specialty.

 

Source Credit: https://venturebeat.com/2019/08/22/stalicla-announces-completion-of-pre-ind-meeting-with-fda-on-stp1-for-subgroup-of-patients-with-autism-spectrum-disorder-asd/