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Ketabon Presents New Data Showing Antidepressant Effects of Oral Ketamine (KET01) Are Independent of Dissociation

MUNICH, Oct. 15, 2025 (GLOBE NEWSWIRE) -- Ketabon GmbH (“Ketabon” or “the Company”), a joint venture between HMNC Brain Health and Develco Pharma, today announced new data from a post hoc analysis of the KET01-02 Phase 2 clinical trial evaluating KET01, its oral prolonged-release formulation of ketamine, for the treatment of treatment-resistant depression (TRD).

The poster, presented at the European College of Neuropsychopharmacology (ECNP) 38th Annual Congress in Amsterdam, demonstrated that dissociative symptoms remained at placebo levels throughout treatment with KET01, and that mediation analysis confirmed the antidepressant efficacy of KET01 was not dependent on dissociation. These findings indicate that the therapeutic benefit of KET01 is distinct from the dissociative effects typically associated with ketamine, further supporting its potential as a safer, more tolerable, and more accessible treatment option for patients with TRD.

“These results reinforce our long-standing hypothesis that the antidepressant properties of ketamine are not mediated by dissociation,” said Dr. Hans Eriksson, Chief Medical Officer of HMNC Brain Health. “By maintaining clinical efficacy without inducing dissociation, KET01 could enable safer, more convenient at-home treatment options for patients with treatment-resistant depression.”

The findings add to growing evidence that dissociation is not a necessary mechanism for ketamine’s antidepressant activity and that oral, prolonged-release formulations can mitigate key tolerability barriers associated with existing intravenous or intranasal therapies.

KET01 is being developed by Ketabon GmbH, a joint venture between HMNC Brain Health and Develco Pharma. The program is part of HMNC’s broader precision psychiatry portfolio, which integrates predictive diagnostics and AI-based biomarker tools to personalize psychiatric treatment.

About the Ketabon Program
The Ketabon program, a joint venture between HMNC Brain Health and Develco Pharma, features an oral prolonged-release formulation of ketamine for treatment-resistant depression (KET01) with minimal dissociative side effects. This innovative approach aims to make ketamine treatment suitable for use at home, potentially improving the risk profile and patient convenience compared to existing intravenous and intranasal ketamine therapies. The development of oral prolonged-release ketamine could also extend to other indications beyond depression, such as anxiety, aggression, PTSD, and panic disorder.

About HMNC Brain Health
HMNC Brain Health (HMNC Holding GmbH) is a precision psychiatry biopharmaceutical company developing personalized treatments for depression based on predictive genetic selection tools. The company’s pipeline includes three Phase 2 programs in Major Depressive Disorder (MDD): Nelivabon, developing a vasopressin V1b receptor antagonist paired with a proprietary genetic selection tool; Cortibon, developing a CRHR1 antagonist with a matching companion diagnostic; and Ketabon, developing KET01, a prolonged-release oral ketamine formulation designed for safe, at-home treatment.

About Develco Pharma
Develco Pharma is a Swiss-German pharmaceutical company headquartered in Pratteln, Switzerland, specializing in the development and manufacture of orally administered modified, prolonged & chrono-release drugs. Established in 2006, the company has a workforce of 130 employees and a state-of-the-art production facility in Schopfheim, Germany. Develco develops generic, hybrid, value-added, and innovative formulations backed by clinical data for the delayed or modified release of active ingredients. With approximately 180 market approvals worldwide, Develco Pharma is recognized as a leading provider of pharmaceuticals across various disease areas. More information at www.develco.ch

Media contacts:
Anne Donohoe
+1 732-620-0033
hmnc@kcsa.com

Investors:
Maximilian Doebler
Chief Business Officer
HMNC Brain Health
maximilian.doebler@hmnc-brainhealth.com


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