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

Japan’s SoftBank amid plans to invest in venture capital funds
Japan’s SoftBank amid plans to invest in venture capital funds
By Nikita Chaurasia

The conglomerate plans to mark its presence in Latin America by investing in venture capital funds, with a strategy to deploy nearly $500 million in five to 10 funds. SoftBank Group Corp., a multinational conglomerate based out of Tokyo, reportedly ...

TG Manufacturing acquires contract manufacturing firm TurnKey
TG Manufacturing acquires contract manufacturing firm TurnKey
By Nikita Chaurasia

TurnKey presently supplies a varied group of consumers in the industrial laboratory, defense and gaming industries among others. Using TGM’s advanced manufacturing technology, quality systems and global network and combining them with TurnKe...

Oxurion concludes enrollment of patients for THR-687 Phase 1 trial
Oxurion concludes enrollment of patients for THR-687 Phase 1 trial
By Nikita Chaurasia

12 patients with DME have enrolled into the study.   The results for the Phase 1 trial will be out by the end of 2019. Oxurion NV, a biopharmaceutical firm involved in the development of innovative treatments to preserve vision of diabetic...