PHASE II PROOF-OF-CONCEPT
TO STUDY TRD PATIENTS RESISTANT TO STANDARD ANTIDEPRESSANTS
Munich, August 24, 2021 – Ketabon GmbH (“Ketabon” or the “company”), together with HMNC Brain Health and Develco Pharma, will advance the development of an investigational oral prolonged-release formulation of ketamine targeting Treatment-Resistant Depression (TRD) with a clinical phase-II-study that will commence in Q4 2021. Ketabon will initiate a Contract Research Organization (CRO)-led proof-of-concept study. The study will be managed by SCOPE, an internationally renowned CRO headquartered in Germany.
Dr. Hans Eriksson, Chief Clinical Development Officer at Ketabon and HMNC Brain Health, noted: “TRD patients with insufficient response to standard antidepressants represent about 30 percent of all patients suffering from Major Depressive Disorder. Within this group, ketamine has already achieved high response rates. The pharmacokinetic profile of our prolonged-release formulation could significantly improve the risk profile and patient convenience, by eliminating dissociative side effects compared to the currently applied therapies.”
“Our oral prolonged-release formulation of ketamine could sustainably transform the therapy of Treatment-Resistant Depression,” adds Dr. Markus Zimmer, Co-CEO of Ketabon and Member of the Board at Develco Pharma. “On top of the targeted medical benefits, the compound has the potential to be administered outside the ambulatory setting, resulting in a potentially higher level of patient compliance and accessibility.”
Data from the Ketabon project trial is likely to be reported in Q1 2023. An investigator-initiated phase II proof-of-concept ketamine study is ongoing at the renowned Psychiatric University Clinic Zurich and should lead to first data as early as Q1, 2022.
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.
ABOUT HMNC BRAIN HEALTH
HMNC Brain Health (HMNC Holding GmbH) is a global precision psychiatry biopharma company, pioneering the development of personalized therapies, powered by its nascent AI platform and predictive companion diagnostics suite, leading to far shorter treatment durations, higher remission rates, and low side effects. The company develops a unique pipeline for targeting both Major Depressive Disorder (MDD) and Treatment-Resistant Depression (TRD). The company has operations in both the US and Germany and is backed by a renowned global VC, several family offices, and a strategic healthcare investor. HMNC Brain Health now enters the next stage of its development with a large-scale licensing and fundraising agenda.
ABOUT DEVELCO PHARMA
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 pharmaceuticals groups. The company has some 180 market approvals in all (products of different dosages) in Europe, the US, Middle- East, South Africa, Asia, and Australia.
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