BRIEF—Ketabon Phase II success with KET101

Germany’s Ketabon GmbH, a joint venture between HMNC Brain Health and Develco Pharma, today announced today top-line results from its Phase II 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 240mg/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 four-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 240mg/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.