Ketabon GmbH Reports Top-Line Results From Phase 2 Trial of Take-at-Home, Oral Ketamine Option for Treatment-Resistant Depression

Ketabon, a joint venture between HMNC Brain Health and Develco Pharma, recently announced top-line results from its Phase 2 KET01-02 Ketabon study with lead asset KET01. KET01 is an oral adjunctive treatment featuring a prolonged-release formulation of ketamine and is being studied in patients with treatment-resistant depression (TRD).

KET01, at a 240-mg/day dose, demonstrated rapidly occurring, and clinically relevant improvements in depressive severity with statistical significance versus placebo on Day 4 and Day 7. The improvements from baseline were sustained while on active treatment until Day 21, and also after the 4-week follow-up period. The placebo-treated arm showed an improvement over time, and at the primary endpoint, Day 21, the change from baseline in the 240 mg/day arm did not reach statistical significance compared to placebo. Importantly, KET01’s antidepressant effects were not associated with the typical findings of other ketamine-based treatments, including increased dissociation, heart rate, and blood pressure, which have been an impediment to the clinical uptake of treatments with ketamine and esketamine for depression.

“We are highly encouraged by the top-line results of KET01-02, which have the potential to transform the treatment landscape for patients continuing to suffer from TRD,” said HMNC Brain Health’s Chief Medical Officer, Dr. Hans Eriksson. “Notably, these results were not associated with a signal of dissociative symptoms, as measured by the Clinician-Administered Dissociative States Scale – or CADSS – suggesting that the oral prolonged-release administration has the potential to be a robust antidepressant that offers better tolerability than other forms of ketamine-based treatments.”

The trial investigated the efficacy, safety, and tolerability of KET01 in 122 out-patients with current major depressive episodes not responding to a minimum of two standard antidepressants, thereby fulfilling the criteria for TRD. Patients were administered doses of 120 mg/day KET01, 240 mg/day KET01, or placebo given once daily in addition to their ongoing standard antidepressant treatment over a three-week period. The study was conducted across 29 sites in Germany, Poland, and the Czech Republic.

“KET01 offers rapid improvement of depressive symptoms while the occurrence of dissociative events interestingly seems to be lower than in currently used ketamine-based treatments. This could lead to wider and more convenient, private at-home use,” added Professor Martin Walter, Chair and Head of the Department of Psychiatry and Psychotherapy, University Jena, who is the international Coordinating Investigator of the study. “TRD is a major medical problem affecting close to a hundred million people worldwide, and patients suffering from this condition currently have very limited treatment options. While ketamine has been shown to provide effective relief, it has been hampered by the high incidence of dissociative side effects and other adverse events, leading to the need for resource-intensive monitoring programs. KET01 has the potential opportunity to vastly change this paradigm.”

HMNC Brain Health (HMNC Holding GmbH) is a global precision psychiatry biopharma company pioneering the development of personalized therapies powered by predictive companion diagnostics, leading to higher remission rates. The company develops a unique pipeline for targeting both Major Depressive Disorder (MDD) and Treatment-Resistant Depression (TRD). The company has a presence in both Germany and the US and is backed by a renowned global VC, several family offices, and a strategic healthcare investor. The company now enters the next stage of its development with a large-scale licensing and fundraising agenda.

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 pharmaceutical groups. The company has some 180 market approvals in all (products of different dosages) in Europe, the US, the Middle East, South Africa, Asia, and Australia.

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 resulting in a decreased need for monitoring under medical supervision. TRD patients with insufficient response to standard antidepressants represent close to 30% of an overall estimated number of 320 million patients worldwide suffering from major depressive disorder. Clinical development of oral prolonged-release ketamine could also be potentially expanded into other indications beyond depression, such as anxiety, aggression, PTSD, and panic disorder. For more information, please visit https://www.ketabon.health/.