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

Syndax Pharmaceuticals reveals data from phase 1 trial of axatilimab
Syndax Pharmaceuticals reveals data from phase 1 trial of axatilimab
By Nikita Chaurasia

According to reliable sources, Massachusetts-headquartered clinical stage biopharmaceutical company, Syndax Pharmaceuticals Inc. has revealed an updated data from its Phase 1 trial of its patent axatilimab. The company will reportedly present the dat...

Xiaomi shares drop by 7.1% after raising USD 3.9 billion in equity deal
Xiaomi shares drop by 7.1% after raising USD 3.9 billion in equity deal
By Nikita Chaurasia

Shares of Xiaomi Corporation, a Chinese multinational electronics company, witnessed a 7.1% drop during Hong Kong trading after the company secured USD 3.91 billion in fund raising which also included the city’s top-up placement. The company h...

Supercom signs a supply contract of PureSecurity EM suite in Wisconsin
Supercom signs a supply contract of PureSecurity EM suite in Wisconsin
By Nikita Chaurasia

Israel-based leading provider of advanced solutions for cybersecurity, IoT (Internet of Things) and e-Government sectors Supercom has reportedly signed a supply agreement to deliver its PureSecurity EM (Electronic Monitoring) product suite in Wiscons...