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GRIN Therapeutics

GRIN Therapeutics Trial on the
Safety and Efficacy of Radiprodil

The Beeline Study

GRIN Therapeutics has dosed the first patient in its global phase 3 Beeline trial evaluating radiprodil, an investigational therapy for individuals with GRIN –related neurodevelopmental disorder caused by gain-of-function variants, according to a company announcement.

The milestone marks the start of the first phase 3 program specifically designed to test a targeted treatment intended to address the underlying biology of GRIN Disorders rather than individual symptoms alone.

Radiprodil targets the NMDA receptor, which is created from DNA instructions contained in the GRIN genes. As a result, this drug is hoped to be more effective than general epilepsy drugs like Keptra and Valproic Acid. A smaller, earlier trial showed promise in treating GRIN-related epilepsy and other symptoms.

Clinical Trial - Beeline Study 

  • Drug Candidate: Radiprodil
  • Clinical Sponsor: GRIN Therapeutics
  • Trial Name: Bee Line
  • Gene Eligibility: Gain of function GRIN Variants
  • Age Eligibility: 1 month to 18 years
  • Epilepsy Requirement?: No. This trial is divided into two groups, or cohorts, to make sure more children with GoF GRIN disorders can participate. Cohort 1 is for patients who experience a minimum of one countable seizure every week. Cohort 2 is open to patients who either do not have epilepsy or who have seizures but do not meet that one-per-week minimum, allowing children with primarily neurodevelopmental symptoms to also be included.
  • Will patients on placebo get access to the drug candidate? Yes. Participants who receive the placebo (the dummy pill) will gain access to the active Radiprodil drug after completing the initial phase (where neither the doctors nor the families know who gets the real drug). This phase lasts approximately 16 weeks for Cohort 1 or 28 weeks for Cohort 2.

  • Sites Currently Open (Recruiting): USA (Colorado, Maryland, Massachusetts, Pennsylvania, and Texas)

  • Sites Coming: Sites in Europe, Asia, Australia, and Canada. Additional US sites in California, DC, Florida, Illinois, Iowa, New Jersey, New York, North Carolina, Ohio, Washington, and Wisconsin.

  • To learn more: US patients can contact Informed DNA to help determine GoF/LoF status and trial eligibility. (https://informeddna.com/grin or 888-503-7727). International contact information will become available when sites outside of the US goes live.