#USA #New York #GRIN Therapeutics #Radiprodil #Neurodevelopmental Disorders

GRIN Therapeutics Highlights Key Developments for Radiprodil

At the recent 2025 International League Against Epilepsy (ILAE) Congress, GRIN Therapeutics, Inc. presented several significant updates regarding their investigational drug Radiprodil. Held in Lisbon, Portugal, this event saw GRIN Therapeutics unveiling their plans for ongoing clinical trials that aim to transform the treatment landscape for several severe neurodevelopmental disorders (NDDs).

Overview of the Presentations

During the congress, GRIN Therapeutics shared three key abstracts that provide an insight into the extensive research and development efforts surrounding Radiprodil. This included:

• - The design and objectives of the global Phase 3 Beeline trial, focusing on GRIN-related NDDs.
• - The Astroscape trial, which investigates Radiprodil’s efficacy in patients with tuberous sclerosis complex (TSC) and focal cortical dysplasia type II (FCD II).
• - A novel study highlighting caregiver perspectives about living with GRIN-NDD.

Beeline Trial Update

The Beeline trial is a pivotal Phase 3 study that aims to assess the safety and efficacy of Radiprodil in patients with GRIN-related neurodevelopmental disorders. According to Dr. Bruce Leuchter, the President and CEO, the insights gathered since the last year’s conference have driven the team to expedite the initiation of this trial. Previous studies, including the Phase 1b Honeycomb trial, indicated that Radiprodil was well tolerated and led to a substantial reduction in seizure frequency, accompanied by behavioral symptom improvements. This is promising for patients suffering from gain-of-function variants across various phenotypes.

Astroscape Trial Insights

In addition, the Astroscape trial aims to evaluate the safety and potential efficacy of Radiprodil in patients experiencing seizures and non-seizure symptoms of TSC and FCD II. These disorders often result from NMDA receptor overexpression, which contributes to clinical symptoms linked to excitatory imbalance. With approximately 30 patients enrolled across different sites in the European Union, Australia, the UK, and Canada, findings from this trial will shape the future development pathways for Radiprodil in these conditions.

Caregiver Perspectives Research

Notably, a third presentation focused on the qualitative research assessing caregivers' views on GRIN-NDD. This groundbreaking study illustrates the complexity of symptoms associated with this condition and emphasizes the caregivers’ need for improvements in patient communication as a primary benefit of therapeutic interventions. These findings play a crucial role in guiding future clinical trial metrics, particularly the Clinical Global Impression of Severity (CGI-S) and change (CGI-C) scales that address caregivers’ priorities.

About Radiprodil

Radiprodil is a negative allosteric modulator specifically targeting the GluN2B subunit of the NMDA receptor. It has garnered significant recognition, including being designated as a Breakthrough Therapy and Orphan Drug by the U.S. FDA, along with similar endorsements by the European Medicines Agency (EMA). Rigid regulatory pathways are in place to facilitate the planned Phase 3 trial, intending to evaluate the impact of this targeted treatment on critical disease aspects, including seizures and behavioral abnormalities.

Conclusion

GRIN Therapeutics is unwavering in its commitment to delivering breakthrough therapies that redefine the standards of care for pediatric neurodevelopmental disorders. The preliminary findings from their ongoing studies provide encouragement not only to medical professionals but also to families affected by these challenging conditions. With the resources and expertise of Neurvati Neurosciences backing them, GRIN Therapeutics is on an ambitious trajectory to bring innovative treatments to market that could significantly enhance the quality of life for patients and caregivers alike.

For further details about GRIN Therapeutics and their clinical trials, visit www.grintherapeutics.com.