GRIN Therapeutics Shares Promising Data From Radiprodil Honeycomb Trial at AES Meeting

Promising Advances in Epilepsy Treatment: Radiprodil

At the recent American Epilepsy Society (AES) Annual Meeting held in Los Angeles, GRIN Therapeutics, Inc. unveiled vital data from its Honeycomb trial focusing on the investigational drug radiprodil. This global Phase 1b open-label study aims to evaluate the safety and effectiveness of radiprodil, a selective negative allosteric modulator of the NMDA receptor subtype 2B (NR2B), specifically for treating GRIN-related neurodevelopmental disorders caused by gain-of-function (GoF) variants.

The notable results shared during the conference revealed that radiprodil was generally well-tolerated among participants. A significant analysis indicated an impressive median reduction of 86% in the frequency of countable motor seizures (CMS) among patients with GoF mutations across various GRIN genotypes. Furthermore, during the trial's maintenance period, 71% of patients experienced a reduction of over 50% in CMS frequency, with several achieving seizure-free days during almost 80% of the observation period. In analyzing the clinical endpoints, any positive changes were evident regardless of seizure incidents, reinforcing the drug's potential impact.

Dr. Bruce Leuchter, president and CEO of GRIN Therapeutics, expressed enthusiasm about the trial's results: “These findings emphasize our ongoing commitment to developing targeted treatment options for individuals affected by GRIN-related disorders. We express gratitude to the patients and families involved, whose participation is crucial to advancing our initiatives.”

The company is set to launch a Phase 3 pivotal trial expected to start in early 2025. This pivotal study will be a randomized, double-blind, placebo-controlled trial featuring two patient cohorts: one tracking those with documented GoF mutations experiencing CMS, and another for patients without observed seizures.

The insights generated from the Honeycomb trial are incredibly relevant, particularly considering that GRIN-related neurodevelopmental disorders, recognized only a little over a decade ago, encompass a range of neurological issues often leading to developmental delay and epilepsy.

Dr. Michael A. Panzara, the Chief Medical Officer, emphasized the urgency in transitioning towards the Phase 3 study, highlighting the approach’s potential to alter patient management in ways previously unimaginable. He said, “Our recent trial data represents a critical milestone in our quest to establish viable treatment vehicles for affected patients.”

Currently, there are no approved therapies to treat GRIN-related neurodevelopmental disorders despite the urgent and unmet clinical needs these patients face. Radiprodil, through its specific targeting of the NMDA receptor components associated with seizures, presents a novel and exciting avenue toward effective therapy.

In preclinical trials, radiprodil has shown promise in exhibiting antiseizure effects in various models linked to enhanced NMDA transmission, which is characteristic of GRIN-related alterations. The pathological potential of this drug may expand beyond just seizure control, implying a more comprehensive effect on patient wellbeing.

GRIN Therapeutics is actively engaged in researching and advancing personalized therapies catered to pediatric neurodevelopmental disorders, striving to provide new hope for patients and families facing these challenges.

As their efforts evolve, GRIN continuously collaborates with regulators, advocacy groups, and treatment practitioners, ensuring that they stay focused on patient-centric developments as they progress through clinical phases. Future insights and results from the Phase 3 trial will be instrumental in confirming radiprodil's role in effectively managing GRIN-related epilepsy, potentially transforming treatment paradigms in this therapeutic area.