STALICLA completes pre-IND meet with FDA on STP1 for patients with ASD
Category: #health  By Nikita Chaurasia  Date: 2019-08-23
  • share
  • Twitter
  • Facebook
  • LinkedIn

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/

  • share
  • Twitter
  • Facebook
  • LinkedIn


About Author

Nikita Chaurasia    

Nikita Chaurasia

Having always been daft at wordplay, Nikita Chaurasia, post the completion of post-graduation, commenced her journey into the content generation cosmos. Endowed with a professional MBA degree in Advertising and Public Relations, Nikita strives to integrate her creativ...

Read More

More News By Nikita Chaurasia

Researchers in UK develop a new, low-cost test kit for COVID-19
Researchers in UK develop a new, low-cost test kit for COVID-19
By Nikita Chaurasia

Amidst growing concerns over the coronavirus pandemic, several health researchers have started to innovate new medical apparatus and drugs to help combat this novel virus. Recently, a bunch of researchers from the University of Surrey, Brunel Univers...

InMed files CTA to start second Phase 1 INM-755 clinical trial
InMed files CTA to start second Phase 1 INM-755 clinical trial
By Nikita Chaurasia

InMed Pharmaceuticals Inc., a leading biopharmaceutical company which develops medications targeting diseases with unmet needs, has reportedly announced the filing of CTA (Clinical Trial Application) in the Netherlands to commence a second Phase 1 tr...

Vapotherm reveals business update following COVID-19 pandemic
Vapotherm reveals business update following COVID-19 pandemic
By Nikita Chaurasia

Vapotherm, Inc., a global medical technology firm developing and manufacturing proprietary Hi-VNI Technology products, has reportedly announced an update on its business in response to the COVID-19 pandemic. Sources cite that, as result of COVID-19,...