US-based biotechnology company Mind Medicine (MindMed) has dosed the first subject in the 52-week Phase III Voyage study of MM120 orally disintegrating tablets (MM120 ODT) for the treatment of generalised anxiety disorder (GAD).
The first of two Phase III trials, Voyage is designed to assess the therapy’s safety and efficacy versus placebo among nearly 200 US subjects.
Go deeper with GlobalData
It will be carried out in two segments, with the first being a randomised, placebo-controlled 12-week period and the second being a 40-week extension phase offering open-label treatment based on symptom severity.
Change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) at week 12 is the trial’s primary endpoint, aligning with the durable clinical effect observed in the Phase IIb study.
MindMed chief medical officer Daniel Karlin said: “Today marks a pivotal moment in our journey towards advancing a novel treatment option for the 20 million people in the US living with GAD.
“Building on our scientifically rigorous Phase IIb study, which demonstrated efficacy that far exceeds today’s standard of care and a favourable tolerability profile, our Phase III studies are designed to adhere to the highest clinical and ethical standards and are in alignment with guidance from the US Food and Drug Administration.”
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataMM120 ODT is a pharmaceutically optimised form of lysergide D-tartrate that functions as a partial agonist at human serotonin-2A (5-HT2A) receptors, incorporating Catalent‘s Zydis ODT fast-dissolve technology.
The Phase III clinical development programme also includes the Emerge study in major depressive disorder (MDD) and the Panorama study in GAD.
Panorama is set to begin in the first half of next year in both Europe and the US, with MindMed also considering additional clinical indications for the therapy.
The US Food and Drug Administration has granted MM120 ODT breakthrough therapy designation based on initial Phase IIb study data and other research.
