Phase II Proof-of-Concept to study TRD patients resistant to standard antidepressants
MUNICH, Germany, Aug. 24, 2021 (GLOBE NEWSWIRE) -- HMNC Brain Health (“HMNC” or the “company”), a clinical stage biopharma company pioneering the development of personalized therapies powered by predictive companion diagnostics, 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. HMNC and Swiss-based Develco Pharma have created a joint venture and formed the company Ketabon, which 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, HMNC Brain Health’s Chief Clinical Development Officer, 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.
About HMNC Brain Health
HMNC Brain Health (HMNC Holding GmbH) is a biopharma company pioneering in developing personalized therapies powered by predictive companion diagnostics, leading to far shorter treatments and higher remission. The company develops a unique pipeline for targeting both major depressive disorder (MDD) and treatment-resistant depression (TRD). HMNC Brain Health is located at one of the leading European biotech hubs in Munich and backed by renowned family offices. The company now enters the next stage of its development with a large-scale licensing and fundraising agenda.
About the Ketabon Project
Within the Ketabon project, HMNC Brain Health, and Develco Pharma in Switzerland develop an oral prolonged-release (PR) formulation of ketamine for treatment resistant depression (TRD) without dissociative side effects, currently in investigator-initiated Phase-II. The pharmacokinetic profile of the prolonged-release formulation could significantly improve the risk profile and patient convenience, by eliminating dissociative side effects compared to the currently applied intravenous and intranasal therapies. As TRD patients with insufficient response to standard antidepressants represent about 30 percent of all patients suffering from major depressive disorder and ketamine shows high response rates, the project represents a huge market potential. Clinical development of oral prolonged-release ketamine could also be expanded into other indications such as social anxiety, aggression, or panic disorder in the future.
SCOPE International is firmly positioned in the clinical research market as a customer-oriented contract research organization that has offices in 16 countries throughout Europe and USA. SCOPE International provides the complete range of clinical development and consulting services to the pharmaceutical, biotechnology and medical device industries, and is supported by long established partnerships in other geographies. As a full-service provider SCOPE International sets the highest standards for the quality of its cost-effective services while achieving industry leading benchmarks in operational performance and timelines.
Alexander Schmidt, (Europe)
Telefon: +49 151 22 99 39 765
Anne Donohoe (U.S.)