“Definium Therapeutics has scored a third straight phase 3 win for its LSD formula, with the psychedelic significantly alleviating anxiety symptoms and setting up an FDA filing next year.

While the Panorama trial did compare Definium’s DT120 ODT to placebo, the study also pitted the 100 μg dose against a 50 μg dose, which is meant to still be psychoactive but not produce any therapeutic benefit. Panorama enrolled 245 patients.

DT120 easily trounced placebo as it did in the phase 3 Voyage trial a month ago, reducing scores on the Hamilton Anxiety Rating Scale (HAM-A) by 9.8 points at week 12 after treatment compared to 4.7 points for the placebo.

This 5.1-point difference between the 100 μg dose and placebo beat the 3.6-point placebo-adjusted mark seen in the 52-patient 50 μg dose arm, though the 50 μg group was not powered for statistical analysis. In the previous Voyage trial, 100 µg DT120 scored a 5.4-point placebo-adjusted reduction in HAM-A score.

DT120 also notched a phase 3 win in major depressive disorder in June. The drug is given in a single eight-hour session during which patients are monitored by a chaperone who guides them through the effects.”

From Fierce Biotech.