MindMed Embarks on Phase 3 Voyage Study for Generalised Anxiety Disorder

MindMed has taken a significant step forward in the development of innovative treatments for Generalised Anxiety Disorder (GAD), announcing the dosing of the first patient in its Phase 3 Voyage study of MM120 ODT. 

This pharmaceutically optimised form of lysergide D-tartrate (LSD) is designed to offer a transformative therapeutic option for individuals living with this debilitating condition.

The Voyage study will evaluate the efficacy and safety of MM120 ODT compared to a placebo, with approximately 200 participants expected to enrol across the United States. The study builds on robust Phase 2b results, which demonstrated the compound’s efficacy exceeding current standards of care, alongside a favourable tolerability profile. 

The Chief Medical Officer of MindMed called this development a “pivotal moment” in the company’s mission to provide a novel treatment for the 20 million adults in the US affected by GAD.

A Rigorous Study Design to Ensure Credible Results

The 52-week Voyage study consists of two distinct phases: a 12-week randomised, double-blind, placebo-controlled period, followed by a 40-week open-label extension for participants requiring continued care based on symptom severity. 

The primary endpoint will assess changes in the Hamilton Anxiety Rating Scale (HAM-A) at Week 12, leveraging methodologies designed to mitigate unblinding and isolate the standalone drug effects of MM120 ODT.

Generalised Anxiety Disorder is a condition with substantial unmet medical needs, and transformational innovation is urgently required, stated an investigator involved in the study. They further continued to express that MindMed’s rigorous approach represents hope for a new and effective treatment option for GAD patients.

Innovative Approach to Address Unmet Needs

GAD impacts around 20 million adults in the US, contributing to severe personal and societal burdens. Yet, innovation in treatment has remained stagnant for decades. 

MM120 ODT leverages rapid absorption and enhanced bioavailability to improve therapeutic outcomes, presenting a novel solution to an enduring problem.

The U.S. Food and Drug Administration (FDA) has recognised the programme’s potential, granting Breakthrough Therapy Designation to MM120. This designation underscores the urgency and importance of advancing treatments for conditions like GAD, where existing options often fall short.

Expanding Horizons with Global Clinical Development

Building on the momentum of the Voyage study, MindMed is preparing to launch the Panorama study in the US and Europe in the first half of 2025. 

This expansion underscores the company’s commitment to addressing GAD on a global scale, ensuring access to cutting-edge treatment options for more patients.

A New Chapter for GAD Treatment

MindMed’s Phase 3 Voyage study marks a critical juncture in the pursuit of innovative solutions for GAD, offering hope to millions of individuals who have faced limited treatment options. 

With a strong foundation of promising Phase 2b results and the endorsement of Breakthrough Therapy Designation, MM120 ODT has the potential to redefine the standard of care. 

As MindMed progresses with its clinical development programme, it continues to pave the way for a future where patients with GAD can achieve better outcomes and improved quality of life.

News Credits: MindMed begins phase 3 study of MM120 for anxiety disorder

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