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Prolonged-Release Ketamine Formulation Shows Promise for TRD in Trial
HMNC Brain Health, in partnership with Develco Pharma, has released top-line results from a Phase 2 trial of KET01, an oral formulation of ketamine for treatment-resistant depression (TRD).
The trial examined whether KET01, administered in doses of 240 mg per day and 160 mg per day for 15 days to patients with TRD as an adjunct treatment to standard antidepressants, could improve depressive symptoms compared with a placebo.
After 15 days, the highest dose administered (240 mg per day) was associated with a larger improvement as measured using the Montgomery-Asberg Depression Rating Scale compared with a placebo. KET01 was also found to have “substantially limited” dissociative side effects, with Clinician-Administered Dissociative States Scale scores comparable to those of the placebo.
“The encouraging preliminary results we have seen demonstrate the safety of KET01, showing the potential for development of a first-in-class, oral prolonged-release formulation of ketamine treatment for patients suffering from treatment-resistant depression,” HMNC Brain Health Chief Clinical Development Officer Dr Hans Eriksson said in a news release.
“In addition, our data suggest that KET01 is rapidly acting with a clinically meaningful improvement compared with placebo already after 7 days, which stands in sharp contrast to standard antidepressants which have a delayed onset of action of up to several weeks.”
HMNC, along with Develco, is slated to start a larger, multinational, contract research organization-led Phase 2 randomized, double-blind, placebo-controlled trial in TRD patients in the second quarter of 2022. The company expects to have first results from the trial by mid-2023.
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