#United States #New York #Major Depressive Disorder #Gilgamesh Pharma #Blixeprodil

Groundbreaking Results from Gilgamesh Pharma

Gilgamesh Pharma, a pioneering neuroscience company, has announced significant findings following its Phase 2a clinical study on blixeprodil (GM-1020), a new oral NMDA receptor antagonist designed for treating Major Depressive Disorder (MDD). This study, which aimed to evaluate blixeprodil's antidepressant effects, revealed both rapid and durable benefits for patients suffering from moderate to severe depression.

Study Overview

Conducted with 46 participants diagnosed with MDD, the study was structured in two main parts:

• - Part A: This segment involved a randomized, double-blind, placebo-controlled trial with a single dose of 140 mg of blixeprodil.
• - Part B: Participants who completed the first phase then proceeded to a multiple-dose extension where they received either 140 or 210 mg doses of blixeprodil twice a week for two weeks. After treatment, all subjects were observed for an additional 28 days.

Key Findings

The results from Part A demonstrated a noteworthy reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) score, revealing a 6.3-point improvement in those who received blixeprodil compared to those on placebo just 24 hours post-dose (p = 0.006). Moreover, after eight days, a significant reduction of 5.1 points was noted (p = 0.076). Due to the sustained effects observed after the initial dosage, the efficacy analyses concentrated solely on the results from this first phase.

In Part B, both doses of blixeprodil exhibited continued improvements on the depression rating scores, culminating in a combined remission rate of 53% by Day 42. Encouragingly, these benefits persisted for 28 days following treatment without the need for additional dosing. Importantly, participants reported that the treatment was safe and well-tolerated, with no severe adverse events prompting discontinuation of the drug.

Expert Commentary

The CEO of Gilgamesh Pharma, Dr. Jonathan Sporn, emphasized the significance of these results, stating, “These findings represent a pivotal advancement in our mission to transform depression treatment. Blixeprodil’s robust efficacy and safety establish it as a unique option within the current antidepressant landscape.” He also highlighted plans to pursue at-home administration owing to the drug's favorable safety profile and oral format.

Dr. Gerard Sanacora, a prominent member of the Gilgamesh Scientific Advisory Board and the Director at the Yale Depression Research Program, acknowledged the importance of these data: “Blixeprodil’s impressive efficacy combined with a favorable safety profile presents a significant evolution in the treatment landscape, potentially enhancing accessibility for patients suffering from major depression.”

Future Directions

Dr. Jorge A. Quiroz, the Chief Development and Strategy Officer at Gilgamesh Pharma, is set to present these trails' findings at the upcoming American College of Neuropsychopharmacology Conference in January 2026. Gilgamesh Pharma aims to advance blixeprodil into late-stage clinical trials, refining dosing strategies to maximize benefits and enhance the patient experience.

About Blixeprodil

Blixeprodil represents a novel approach in psychiatry, being the first oral NMDA receptor antagonist that showcases quick-onset action coupled with substantial efficacy. This investigational drug not only provides hope for patients resistant to conventional treatments but also holds potential for elevating the standard in the management of Major Depressive Disorder.

Conclusion

With over 20 million individuals in the U.S. battling Major Depressive Disorder, the emergence of effective, swift-acting treatments is imperative. As Gilgamesh Pharma continues to unfold its clinical advancements with blixeprodil, the possibility of improved lives for many suffering from depression looms on the horizon. The development of therapies that extend beyond mere symptom management could herald a new era in psychiatric care.

For more information about Gilgamesh Pharma and its innovative pipeline, please visit Gilgamesh Pharmaceutical.