First patient dosed in second Phase 2 add-on Ketamine Trial in Treatment-Resistant Depression (TRD)
Dosing has commenced in HMNC Brain Health and Develco Pharma’s Phase 2 oral prolonged-release Ketamine (KET01) Study
The trial will assess the efficacy, safety, and tolerability of add-on treatment with KET01 in 117 patients suffering from Treatment-Resistant Depression (TRD)
Munich, June 8, 2022 – HMNC Brain Health (“HMNC” or the “company”), together with Develco pharma, today announced the dosing of the first patient in their second Phase 2 trial with oral prolonged-release Ketamine (KET01) for Treatment-Resistant Depression.
HMNC is a global precision psychiatry biopharma company, pioneering the development of personalized therapies powered by its nascent AI platform and predictive companion diagnostics suite, leading to far shorter treatment durations, higher remission rates, and low side effects has partnered with Develco pharma, a company specializing in the development and manufacture of orally administered modified, prolonged & chrono release drugs, in this trial.
The trial will assess the efficacy, safety, and tolerability of add-on treatment with Ketamine hydrochloride prolonged-release tablets (KET01) in patients suffering from Treatment-Resistant depression (TRD). It will enroll 117 TRD patients at approximately 38 clinical sites. The study's selection criteria for patients to be included was defined by non-response to a minimum of two standard antidepressants in their current major depressive episode. The trial is expected to confirm the results of the previous trial, with early-onset of efficacy, showing placebo-level dissociative side effects, and excellent tolerability, furthering the take-at-home potential of this novel treatment.
“Our first investigator-initiated Phase 2 Proof of concept trial, which we announced the preliminary results for at 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,” said Dr. Hans Eriksson, Chief Medical Officer at HMNC Brain Health.
The Ketabon program, which is a joint venture between HMNC Brain Health and Swiss-based Develco Pharma, funded the trial. Patients will be randomized 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.
About HMNC Brain Health
HMNC Brain Health (HMNC Holding GmbH) is a global precision psychiatry biopharma company, pioneering the development of personalized therapies, powered by its nascent AI platform and predictive companion diagnostics suite, leading to far shorter treatment durations, higher remission rates, and low side effects. The company develops a unique pipeline for targeting both Major Depressive Disorder (MDD) and Treatment-Resistant Depression (TRD). The company has operations in both the US and Germany and is backed by a renowned global VC, several family offices, and a strategic healthcare investor. HMNC Brain Health now enters the next stage of its development with a large-scale licensing and fundraising agenda.
About Develco Pharma
With headquarters in Pratteln/ Switzerland, Develco Pharma is a Swiss-German pharmaceutical company specializing in the development and manufacture of orally administered modified, prolonged & chrono release drugs containing known active ingredients. Established in 2006, today the company has a workforce of 130 employees. In Germany, a state-of-the-art production facility for analgesics & other indications has been in operation in Schopfheim, in the Baden region, since 2016. Develco identifies and defines pharmaceutical products containing known active ingredients and develops generic, hybrid, value added and innovative formulations backed by clinical data for the delayed or modified release of active ingredients. On the strength of its experience and innovativeness, the company has emerged as an internationally recognized provider of pharmaceuticals for the treatment of several disease areas. The customer base of Develco Pharma includes global pharmaceuticals groups. The company has some 180 market approvals in all (products of different dosages) in Europe, the US, Middle- East, South Africa, Asia,andAustralia.
About the Ketabon Program
The Ketabon program, a joint venture between HMNC Brain Health and Develco Pharma in Switzerland, comprises an oral prolonged-release formulation of ketamine for TRD with minimal dissociative side effects. The pharmacokinetic profile of the prolonged-release formulation could significantly improve the risk profile and patient convenience, by minimizing dissociative side effects compared to the currently applied intravenous and intranasal ketamine therapies. TRD patients with insufficient response to standard antidepressants represent 30% of an overall estimated number of 320 million patients worldwide suffering from major depressive disorder. In this group, prolonged-release ketamine has shown high response rates. Clinical development of oral prolonged-release ketamine could also be potentially expanded into other indications, such as anxiety, aggression, PTSD, and panic disorder.
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