Logo

Applied Therapeutics Reports Results for Govorestat (AT-007) in P-III Trial for the Treatment of Sorbitol Dehydrogenase (SORD) Deficiency

Share this
Applied Therapeutics

Applied Therapeutics Reports Results for Govorestat (AT-007) in P-III Trial for the Treatment of Sorbitol Dehydrogenase (SORD) Deficiency

Shots:

  • The P-III (INSPIRE) trial evaluates Govorestat (QD) vs PBO in patients (n=56) with SORD deficiency aged 16-55yrs. across the US & EU. The 1EPs was correlation of sorbitol with composite clinical outcomes & 2EP was effects on CMT-HI
  • The 12mos. interim analysis depicted a statistically significant correlation between sorbitol level & prespecified CMT-FOM, sustained reduction in sorbitol level & highly significant effects on the CMT-HI. Based on these results, the company plans to submit an NDA to the US FDA
  • Govorestat is a CNS penetrant ARI being developed for the treatment of various neurological diseases incl. Galactosemia, SORD Deficiency & PMM2-CDG. Govorestat received the OMPD (EMA) & ODD, PRDD & FTD (US FDA)

Ref: Applied Therapeutics | Image: Applied Therapeutics

Related News:- Applied Therapeutics Reports P-III trial (INSPIRE) Results of AT-007 for Sorbitol Dehydrogenase Deficiency

PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com

Click here to­ read the full press release 

Shivani Chandra

Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions