The first patient has been dosed in HMNC and Develco Pharma’s Phase 2 oral prolonged-release Ketamine (KET01) Study.
According to real-world data from Europe, TRD affects ~20 per cent of patients with major depressive disorder (MDD). People living with TRD have a significantly lower quality of life, use more health rescues and have decreased work productivity and general activity.
To understand if ketamine can help this population of patients, HMNC’s trial will enrol 117 patients who have not responded to a minimum of two standard antidepressants in their current major depressive episode.
It will be carried out across 38 clinical sites, and is expected to confirm the results of the previous trial, with early-onset of efficacy, showing placebo-level dissociative side effects and high tolerability, which HMNC says furthers the take-at-home potential of this novel treatment.
Chief Medical Officer at HMNC Brain Health, Dr Hans Eriksson, commented: “Our first investigator-initiated Phase 2 Proof of concept trial, which we announced the preliminary results for at the end of March, suggested a positive trend in efficacy for KET01, which appears to be a safe and well-tolerated antidepressant with substantially limited dissociative side effects.”
Trial participants will be randomised into three treatment groups and will either receive a placebo, KET01 120 mg, or KET01 240 mg once daily (OD), in addition to their ongoing standard antidepressant treatment over a period of three weeks.
The primary endpoint is the change on the established Montgomery–Åsberg Depression Rating Scale (MADRS) for depressive severity at day 21 compared to placebo.
HMNC Brain Health CEO, Benedikt von Braunmühl, added: “We are very pleased to have achieved this important milestone in the development of KET01 for Treatment-Resistant Depression. We believe KET01 has the potential to improve the lives of patients who are not responding to standard antidepressant therapies, and we are looking forward to further develop this potential medication with the insights generated from this trial”.
Topline data from the study is expected to be reported in the second quarter of 2023. The Ketabon program, which is a joint venture between HMNC Brain Health and Swiss-based Develco Pharma, funded the trial.
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