Mind Medicine Inc., a company specializing in the development of treatments for brain health disorders, has received a breakthrough designation from the FDA for its MM120 (lysergide d-tartrate) program aimed at treating generalized anxiety disorder (GAD). The Phase 2b study of MM120 in GAD has shown significant efficacy, meeting key secondary endpoints with sustained activity observed through Week 12.

Dr. David Feifel, a seasoned researcher in psychiatry, expressed his surprise at MM120's rapid and robust efficacy, which persisted for 12 weeks after a single dose. These findings indicate promising potential for MM120 in treating anxiety, offering hope for patients and clinicians alike.

The optimal dose of MM120, 100 µg, exhibited a significant improvement over placebo at Week 12, with notable clinical response and remission rates sustained. The drug showed rapid onset of action, with improvements observed as early as study day 2, and maintained effectiveness throughout the 12-week period.

Recognizing the urgent need for effective GAD treatments, especially for patients unresponsive to current medications, the FDA has designated MM120 as a breakthrough therapy. MindMed plans to engage with the FDA for an End-of-Phase 2 meeting in the first half of 2024 and initiate a Phase 3 clinical program in the latter half of the year.

MindMed, emphasized the significance of FDA's breakthrough designation and the Phase 2b data, reaffirming the company's commitment to addressing the unmet needs of individuals with GAD.

In the Phase 2b study, MM120 demonstrated good tolerability, with most adverse events being mild to moderate and transient, occurring on dosing day. Prior to treatment, participants were tapered off other medications, ensuring the study's focus on MM120's effects.

Dr. Reid Robison praised the study design for isolating MM120's effects and expressed optimism about the potential benefits for patients.

The primary data analyses from the study have been accepted for presentation at the American Psychiatric Association’s annual meeting and will be submitted for publication in a leading medical journal.

The Company will host a webcast to discuss the Phase 2b results, accessible via its website. GAD affects millions of people, causing significant impairment, and despite its prevalence, there has been little innovation in its treatment in recent years.

MM120, a synthetic ergotamine, acts as a partial agonist at human serotonin-2A receptors, and MindMed is exploring its potential applications beyond GAD.

Overall, MM120's breakthrough designation and promising Phase 2b results signify a significant step forward in addressing the challenges of treating GAD and offer hope for improved outcomes for patients.

 

Source: businesswire.com

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