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Candidate505(b) (1)

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EPX-100

DS Single pivotal Study

Complete Enrollment 2Q22

  • Topline results expected in 1Q2023
  • ODD/RPD for DS granted from the FDA
  • NOL released from Health Canada
  • CTA approved from MHRA, UK

EPX-100

LGS Single pivotal Study

Complete Enrollment 3Q22

  • IND appoved from the FDA
  • ODD/RPD for LGS granted from the FDA
  • Topline results expected in 2Q2023

EPX-100

Otahara Syndrome

IND Enabling

  • ODD/RPD for OS granted from the FDA

EPX-101/102/103

LGS/DS

IND Enabling Studies

  • IND enabling tox studies
  • Route scouting
  • Formulation Develeopment

505(b) (2) EPX-200

LGS/DS

IND Filing

  • Human PoC for DS/LGS confirmed
  • ODD for DS granted from the FDA
  • OMD for DS granted from the FMA
  • ODD/RPD for LGS granted from the FDA

EPX-300

LGS/DS

IND Filing

  • Human PoC for DS confirmed
  • ODD for DS granted from the FDA

EPX-100 is a first-generation antihistamine safely used from the 1950-1970s. EPX-100 is not currently manufactured or available anywhere in the world. EPX-100 was found to be a powerful suppressor of spontaneous convulsive behavior and electrographic seizures in zebrafish disease models for Dravet Syndrome. EPX-100’s antiepileptic action is not through a histaminergic mechanism of action but acts via modulation of serotonin (5HT) signaling pathways.

EPX-200 is an FDA-approved weight gain management drug which acts via modulation of serotonin (5HT) signaling pathways. EPX-200 was found to be a powerful suppressor of spontaneous convulsive behavior and electrographic seizures in zebrafish disease models for Dravet Syndrome. Promising clinical results support the efficacy of EPX-200 in terms of the reduction of convulsive seizure frequency and/or severity in a small number of patients with Dravet syndrome.

EPX-101, EPX-102, and EPX-103 are EPX-100 analogs, which have been fully confirmed with zebrafish disease model for Dravet syndrome.

All of them were a potent suppressor of spontaneous convulsive behavior and electrographic seizures in this model.

EPX-300 is an FDA-approved antidepressant, anti-anxiety and sleep-inducing insomnia drug which acts via modulation of serotonin (5HT) signaling pathways. EPX-300 was found to be a powerful suppressor of spontaneous convulsive behavior and electrographic seizures in zebrafish disease models for Dravet Syndrome. Human PoC has been confirmed with small no. of patients.

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