Ketabon GmbH eyes KET01’s potential as an at-home option for treatment-resistant depression

A joint venture between HMNC Brain Health and Develco Pharma in Switzerland, Ketabon GmbH recently released top-line results from its phase 2 KET01-02 study of KET01, a slow-release formulation of oral ketamine, for treatment-resistant depression (TRD). KET01 was associated with improvements in depression severity as early as day 1, but the results were not statistically significant at day 21.

The promise of rapid onset without dissociative effects

“This is the second study with KET01 that demonstrates a signal of robust and rapid onset of improvement of depressive symptoms from baseline, without the prominent dissociative effects that have limited the uptake of other ketamine-based treatments,” stated Dr. Hans Eriksson, chief medical officer at Ketabon and HMNC Brain Health.  

He added that conducting the KET01-02 study at home without concerns about administration further bolsters their take-at-home approach.

Regarding the lack of statistical significa…

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At Day 21, low-dose ketamine KET01 shows no statistical edge over placebo.

Ketabon GmbH revealed positive top-line results from its phase 2 KET01-02 study investigating KET01, an oral slow-release formulation of oral ketamine, for treatment-resistant depression (TRD). Results were promising initially. Investigators noted improvements in depression severity as early as day 4, but data were not statistically significant over placebo at day 21.

A look at Ketabon GmbH’s KET01-02 study in treatment-resistant depression

The trial studied KET01 doses of 120 mg and 240 mg per day. It involved 122 individuals who were outpatients with current major depressive episodes not responding to at least two standard antidepressants. Participants received KET01 once daily in addition to a traditional antidepressant treatment over the three-week period. In particular, the 240 mg/day dose showed clinically relevant improvements with statistical significance versus placebo on days 4 and 7. The drug, however, did not maintain significance at day 21.

K…

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