H. Lundbeck A/S (Lundbeck) and Takeda Pharmaceutical Company Limited (Takeda) today jointly announced the plans for the additional clinical phase III studies on Lu AA21004 and phase III studies on Lu AA24530 in patients with major depressive disorder (MDD).
The new programme on Lu AA21004 will consist of four clinical phase III studies including approximately 2,000 patients with moderate to severe depression in addition to a long-term extension study. The planned doses are 10 mg, 15 mg and 20 mg. The pivotal programme is planned to commence in the first half of 2010.
Following the communication of initial top-line MDD results from previous phase III studies with Lu AA21004 in June 2009, additional data from the full programme was received and analysed. These data showed encouraging results for the potential efficacy and the tolerability profile of Lu AA21004.
Data received towards the end of 2009 from the clinical phase III programme, with 560 patients in a MDD trial, showed statistical significance on the primary efficacy endpoint across all tested doses of Lu AA21004 compared to placebo in a primarily European-based trial. Also, encouraging results from an MDD relapse prevention study involving 639 patients showed statistically significant results on maintenance of efficacy in long-term treatment of MDD.
“With the full review of all data and dosages available we have strong data to continue development of Lu AA21004 including exploring the potential at higher dosages than previously studied”, says Executive Vice President Anders Gersel Pedersen, Head of Drug Development at Lundbeck. “We are pleased that with our partner Takeda we are ready to move forward.”
In the completed clinical phase II dose finding study, Lu AA24530 produced consistent statistically significant improvements on the primary efficacy endpoint and on key secondary endpoints for the treatment of MDD. Based on the observed efficacy and tolerability in patients following treatment with Lu AA24530, the clinical phase III program will be initiated. The clinical phase III program will begin with four individual phase III studies of Lu AA24530, including a long-term study and a relapse prevention study. Approximately 2,000 patients are planned to be included investigating doses at 10 mg and 20 mg. Selected trials will include an active reference compound. The pivotal program is, planned to commence by the end of 2010 and may also include future planned phase III studies to further investigate the compound’s benefit and risk profile.
“Central nervous system conditions represent a core therapeutic area of interest for Takeda,” said Nancy Joseph-Ridge, M.D., general manager for Takeda’s pharmaceutical development division. “Together with Lundbeck, we are pleased to continue our development activities for Lu AA21004 and Lu AA24530, further evaluating their potential as a future treatment option for the millions of patients suffering from depression.