Trial planned to investigate ketamine in treatment-resistant depression
pharmafile | August 25, 2021 | News story | Research and Development |
HMNC Brain Health and Develco Pharma have partnered to develop an investigational oral prolonged-release formulation of ketamine, targeting treatment-resistant depression (TRD) with a clinical Phase II study.
HMNC and the 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.
Dr Hans Eriksson, HMNC Brain Health’s Chief Clinical Development Officer, said: “TRD patients with insufficient response to standard antidepressants represent about 30% 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.”
In a release the companies noted that 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.
Data from the Ketabon project trial is likely to be reported in 2023, and an investigator-initiated Phase II proof-of-concept ketamine study is currently ongoing at the Psychiatric University Clinic Zurich and should lead to first data as early as Q1, 2022.
Dr Markus Zimmer, Co-CEO of Ketabon and Member of the Board at Develco Pharma, said: “Our oral prolonged-release formulation of ketamine could sustainably transform the therapy of treatment-resistant depression.
“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.”