HMNC Brain Health and Develco Pharma have announced promising top-line results from the Phase II proof-of-concept investigator-initiated trial of its oral prolonged-release formulation of ketamine (KET01) in Treatment-Resistant Depression (TRD).
The company has stated that the trial suggests a positive trend in efficacy, based on the primary endpoint clinical data.
The data has demonstrated that after 15 days, the highest dose of 240 mg/day KET01 was associated with a larger improvement on the Montgomery-Åsberg Depression Rating Scale (MADRS) compared with placebo.
It also appears to be a safe and well-tolerated antidepressant, with substantially limited dissociative side effects, and scores on the Clinician-Administered Dissociative States Scale (CADSS) similar to those for placebo.
Dr Hans Eriksson, HMNC Brain Health’s chief clinical development officer, said, “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.
“In addition, our data suggest that KET01 is rapidly acting with a clinically meaningful improvement compared with placebo already after seven days, which stands in sharp contrast to standard antidepressants which have a delayed onset of action of up to several weeks.”
The data alsosuggest KET01 has a rapid onset of action, with a clinically meaningful improvement of -5.67 units (95%CI: -12.57, 1.23, p=0.1062) already after seven days compared with placebo.
The study was funded by the Ketabon programme, a joint venture between HMNC Brain Health and Develco Pharma, sponsored by University of Zurich and conducted under the central leadership of Professor Erich Seifritz, Director of the Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric University Hospital Zurich.
Professor Seifritz commented: “We are pleased with the top-level results from this Phase 2 study on Treatment-Resistant Depression with KET01, as they hold significant positive implications for the clinical development of oral prolonged-release ketamine to help those afflicted, making up as many as 30 percent of depression patients.
“Not only does the data suggest this to be a potentially safer treatment for people suffering from Major Depressive Disorder who have not found currently available antidepressants effective, but it could potentially be expanded to include additional mental-health indications in the future.
“Ketabon and the University of Zurich will continue to work together in the development of KET01, with future studies being planned.”
Dr Michael Colla coordinated the medical implementation as head of the clinical trial at the University of Zurich, as successor of professor Annette Brühl, after she moved to the University of Basel. The statistical evaluation of the study was carried out by SCOPE, a globally renowned CRO.
HMNC Brain Health, in partnership with Develco Pharma, is now about to begin a multinational, larger CRO-led Phase II randomiSed, double-blind, placebo-controlled trial in patients with TRD in the second quarter of 2022. First results are expected for mid-2023.
Develco Pharma CEO Dr Martin Renner, commented: “We are highly encouraged by the findings in this study, showing a clinically meaningful improvement and excellent tolerability in patients treated with 240 mg/day KET01. We will bring our experiences from this study to further trials with KET01 and are looking forward to the next steps in the development of this promising medication.”
Eriksson added: “The suggested clinically relevant improvement in efficacy and the good safety and tolerability profile that we saw in the Phase 2 Proof-of-Concept trial support our plans for the larger study which we are preparing to launch.
“With the capabilities of our team and strong Scientific Advisory Board, we are well placed to undertake the next steps for progressing Ketabon towards more studies and the pathway to approval and commercialisation.”
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