Treating Treatment Resistant Depression

T r e a t i n g T r e a t m e n t
Resistant Depression

Ketabon – accessing ketamine’s
antidepressant potential

We develop a potential take-at-home treatment option for the 94 million patients suffering from Treatment-Resistant Depression (TRD) globally.

KET01 is an oral prolonged-release formulation of ketamine. It therefore combines the robust and rapid efficacy of ketamine with superior tolerability, patient convenience, and accessibility compared to current treatment options.

A growing burden
on patients and society

More and more people are suffering from neuropsychiatric disorders, globally. Depression stands out as the most prevalent mental health disease. Especially burdensome for patients and society is Treatment-Resistant Depression (TRD), having immense societal and economic costs which currently are not addressed adequately.

Globally, 970 million people are currently living with a mental health condition (WHO). Depression stands out as the most prevalent mental health disease. With more than 320 million patients, Major Depressive Disorder (MDD) is the leading contributor to disability globally. One in three MDD patients fail to remit after multiple lines of treatment, meeting the criteria for Treatment-Resistant Depression (TRD).

Treatment-Resistant Depression has even greater economic and societal cost than non-TRD depression. Patients with TRD have a worse clinical perspective as the illness comes with more comorbidities, poorer health-related quality of life, and a greater risk of suicide.

Also, there are only limited treatment options: As of now, only two drugs received FDA approval for TRD. This high and growing burden on patients and society calls for a rapidly efficacious, safe and well tolerated treatment for Treatment Resistant Depression.

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Mental Disorders Man Mental Disorders Woman
TRD
MDD

Mental Disorders

MENTAL DISORDERS 970 MIO
MDD 280 MIO
TRD 94 MIO

according to WHO

Pfeil
Ket01
as Full-Circle
Treatment
Option

Treating Treatment-
Resistant Depression

Ketabon aims to unlock ketamine’s full antidepressant potential while at the same time substantially limiting its side effects. We are developing an oral prolonged release formulation of ketamine (KET01) that has the potential to overcome the drawbacks of other ketamine formulations.

KET01 has the potential to

  • Improve tolerability thanks to limited acute side effects, i.e., placebo-level dissociative and cardiovascular effects.
  • Take-at-home treatment potential, leading to improved patient convenience and potentially compliance.
  • Increased accessibility for patients who cannot accommodate to have regular clinic visits.
  • Save cost of up to 70% of the current total cost of ketamine treatment with full reimbursement.

The program’s IP protection provides exclusivity in the U.S. and Europe until 2035.

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Arguably the greatest breakthrough
in the field of depression in
over 60 years

Ketamine is known to have significant antidepressant potential. Its rapid antidepressant effects in TRD-patients especially through intravenous infusions are well studied. Patients describe improvement of depressive symptoms within a matter of hours, which last up to one week. While efficacious, currently applied ketamine treatments including intranasal esketamine come with several limitations.

  • Dissociative and cardiovascular side effects limit tolerability.
  • Need for strict medical supervision restricts patient convenience and ties up scarce resources of medical staff.
  • Limited number of practitioners offering ketamine treatment reduces accessibility.
  • High costs and expenditure of time for patients, clinics and society reduces usability.

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“The discovery of the rapid, efficacious, and sustained effects of ketamine is arguably the greatest breakthrough in the field of depression in over 60 years.”

KOL, Yale University School of Medicine

“Finally, since a long-time I am feeling some emotions again. A lot of positive and some negative emotions, but the negative ones enable me to interact more with my psychotherapy. Overall, it gives me a much better outlook on my future and depressive symptoms.”

TRD patient, KET01 Phase 2 study

“Esketamine gained approval, but I think there are a number of problems with it. It's very expensive and there are issues with how you deliver it.”

KOL, MDD Market Survey, March 2021

“You need to find an at-home way of administering this, removing the hallucinogenic properties to make it more accessible to the broader population – that’s your blue sky.”

Forbes, June 23, 2021

Change the future of treating
Treatment-Resistant Depression with us

We are always open for new partners and fellow pioneers to share our vision of how we treat Treatment Resistant Depression. Join us today or receive more information via the contact below.

HMNC Team

About
Ketabon

Ketabon is a joint venture between HMNC Brain Health and Develco Pharma. The company develops an oral prolonged-release formulation of ketamine for Treatment-Resistant Depression (TRD) with minimal dissociative side effects. This prolonged-release formulation could significantly improve the risk profile and patient convenience, by minimizing dissociative side effects due to its unique pharmacokinetic profile 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 potentially be expanded into other indications.

Markus Zimmer

Dr. Markus Zimmer
Co-CEO

Maximilian Döbler

Dr. Maximilian Döbler
Co-CEO

Hans Eriksson

Dr. Hans Eriksson
CMO

Potential first-line
treatment option

The clinical data to date strongly suggest KET01 as a potential first-line treatment option for Treatment-Resistant Depression. The early read-out from a Proof-of-Concept investigator-initiated clinical trial in 27 TRD patients just recently reaffirmed KET01’s efficacy and tolerability potential.

The trial suggests a positive trend in efficacy, based on the primary endpoint clinical data: After 15 days, the highest dose of 240 mg/day KET01 was associated with a clinically meaningful improvement in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS) compared with placebo (Δ=-4.99, p=0.1499). In addition, KET01 appears to be a safe and well-tolerated antidepressant, with substantially limited dissociative side effects, and scores on the Clinician-Administered Dissociative States Scale (CADSS) similar to those for placebo. Additionally, the data suggest KET01 has a rapid onset of action, with a clinically meaningful improvement of -5.67 units (95%CI: -12.57, 1.23, p=0.1062) already after seven days compared with placebo.

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Improvement in severity of depressive symptoms (Δ =4.99, p=0.150 on MADRS score), after 2 weeks of daily treatment with study medication
Improvement in
mean MADRS score,
Day 15
15 10 5 0
Placebo
Ket-01
160 MG/Day
Ket-01
240 MG/Day

Current Phase 2 trial
and preparing near-term market entry

Based on the promising results from the Proof-of-Concept trial, we initiated a multicenter, double-blind, randomized, placebo-controlled Phase 2 trial in Germany, the Czech Republic and Poland. The study investigates the efficacy, safety, and tolerability of add-on treatment with ketamine hydrochloride prolonged-release tablets (KET01) in patients suffering from Treatment-Resistant Depression.

The trial enrolls 117 TRD patients at approximately 36 clinical sites. Patients are randomized into three treatment groups and receive either 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.

The study is expected to confirm the results of the previous trial, showing early-onset of efficacy, placebo-level dissociative side effects, and excellent tolerability, thereby furthering the take-at-home potential of this novel treatment. Dosing has commenced in Q2 of 2022. We currently expect first read-out in Q2 of 2023.

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Ketabon program

News

01

Head-to-head Trial of Prolonged-Release Oral Ketamine Formulation, KET01, and Intranasal SPRAVATO® ...

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02

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

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03

Ray of Hope
A New, Take-At-Home Ketamine Pill is a Gamechanger for Treatment-Resistant Depression ...

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04

HMNC BRAIN HEALTH AND DEVELCO PHARMA
ANNOUNCE LAST PATIENT BEING RANDOMIZED IN ORAL PROLONGED-RELEASE KETAMINE (KET01) TRIAL ...

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05

FIRST PATIENT DOSED IN SECOND PHASE 2 ADD-ON
KETAMINE TRIAL IN TREATMENT-RESISTANT DEPRESSION (TRD)

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06

PROMISING PRELIMINARY RESULS IN TRD,
SUGGESTING ANTIDEPRESSANT EFFICACY AND PLACEBO-LEVEL DISSOCIATIVE SIDE EFFECTS

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07

PHASE II PROOF-OF-CONCEPT
TO STUDY TRD PATIENTS RESISTANT TO STANDARD ANTIDEPRESSANTS

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Events

01

CNS Summit 2023
Poster #3

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02

CNS Summit 2023
Poster #18

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