Definium chalks up new phase 3 win for LSD-based therapy
A therapy room used to deliver the one-off, therapist-assisted treatment.
Psychedelic drug developer Definium Therapeutics has reported positive phase 3 results with its LSD-based therapy, DT120, in anxiety, sparking a 15% rise in its share price.
Definium – which was formerly known as MindMed – said a 100 mcg dose of its oral dispersible tablet (ODT) formulation of DT120 (lysergide) met all its efficacy objectives in the Voyage trial, including a statistically significant reduction in Hamilton Anxiety Rating Scale (HAM-A) score compared to placebo after 12 weeks in patients with generalised anxiety disorder (GAD).
There was a placebo-adjusted, 5.4-point change on the HAM-A scale with DT120 – 11.6 for the drug and 6.2 with placebo – which Robin Barrow, Definium's chief executive, said was evidence of "unprecedented efficacy" and should "raise the bar for what patients and clinicians expect from GAD treatments."
The improvement in symptoms was apparent within a couple of days of the one-off, therapist-guided treatment – which is administered in a controlled environment – and met Definium's objective of showing a five-point or greater improvement with the psychedelic.
The Voyage result also comes after Definium reported positive results with DT120 in the Emerge trial in patients with major depressive disorder (MDD) in June, including a 7.3-point placebo-adjusted improvement on the Montgomery-Åsberg Depression Rating Scale (MADRS).
Definium is also carrying out additional studies in GAD and MDD – respectively Panorama and Ascend – that are due to read out later this year and in 2027 and, if positive, will open the way for regulatory filings.
A fifth trial, called Haven, is testing DT120 in people living with post-traumatic stress disorder (PTSD) and is due to start next year.
There have been no new medicines approved in the US for GAD since 2007, according to Definium, which hopes to position its therapy for some of the approximately 26 million Americans living with the condition.
GAD is "one of the most undertreated conditions in psychiatry," according to Voyage principal investigator Brian Barnett of the Cleveland Clinic.
"Many of the patients I see have not found relief despite trying multiple therapies," he added. "A single-dose treatment option delivering meaningful benefits for 12 weeks is a promising step forward not found in today's therapies."
Companies developing psychedelic medicines have been boosted by an executive order signed by President Donald Trump in April, directing the FDA to reduce regulatory hurdles that stand in the way of bringing these new drugs to patients.
Among the measures the regulatory authority has been asked to introduce is the extension of the Commissioner's National Priority Voucher (CNPV) – which can cut regulatory review times from months down to a matter of weeks – for "appropriate psychedelic drugs that have received breakthrough therapy designations."
DT120 has already been granted breakthrough status for GAD.
