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Find Clinical Drug Pipeline Developments & Deals by Applied Therapeutics

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            Lead Product(s): AT-007

            Therapeutic Area: Genetic Disease Product Name: AT-007

            Highest Development Status: Phase I/ Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 01, 2021

            Details:

            FDA has lifted the hold and the AT-007 ACTION-Galactosemia Kids pediatric clinical study will resume effective immediately. Dose-escalation portion of the study has been operationally modified to ensure continuous drug treatment and participation throughout the study.

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            Lead Product(s): Gavorestat

            Therapeutic Area: Genetic Disease Product Name: AT-007

            Highest Development Status: Phase I/ Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 21, 2020

            Details:

            The presentations include animal model efficacy data and adult clinical data on the safety and biomarker efficacy of Applied Therapeutics’ investigational candidate for Galactosemia, AT-007, a Central Nervous System (CNS) penetrant Aldose Reductase Inhibitor (ARI).

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            Lead Product(s): Gavorestat

            Therapeutic Area: Genetic Disease Product Name: AT-007

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 24, 2020

            Details:

            AT-007, a novel CNS penetrant Aldose Reductase inhibitor (recently given the INN scientific name gavorestat) has demonstrated biological activity in a validated model of PMM2-CDG.

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            Lead Product(s): Grapiprant

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: AT-001

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 17, 2020

            Details:

            The presentations include data on the safety and specificity of AT-001, as well as data on mechanistic protection from cellular damage during hyperglycemia.

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            Lead Product(s): AT-007

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            Highest Development Status: Phase I/ Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 15, 2020

            Details:

            Applied Therapeutics announced additional supportive biomarker efficacy and safety data for AT-007 in Galactosemia at 40 mg/kg. The company also announced initiation of the AT-007 pediatric trial, ACTION-Galactosemia Kids, in children age 2 to 17.