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20-01-2011 H. Lundbeck A/S via Thomson Reuters — H. Lundbeck A/S (Lundbeck) announced today the advancement of zicronapine into clinical phase III based on the positive clinical phase II data.
The first study in the clinical phase III programme is expected to enrol some 160 patients with the aim to measure the efficacy of zicronapine and risperidone and their relative impact on key metabolic parameters.
Long term relative safety and efficacy is a key factor in determining appropriate use of newer antipsychotics.
The patients will be randomly assigned to zicronapine (7.5mg/day) or risperidone (5mg/day) treatment in a one to one ratio.
The study is expected to enrol patients in several countries in Europe.
Classical short term efficacy studies will be initiated in due time.
The pivotal program is planned to include further phase III studies to investigate the compound’s benefit and risk profile.
“We are very pleased to be able to announce the initiation of the continued programme for zicronapine,” said Executive Vice President Anders Gersel Pedersen, head of Development at Lundbeck.
“With zicronapine, we look forward to be able to offer patients and their physicians a new treatment option within an area still characterised by substantial unmet medical needs.”
Zicronapine (formerly known as Lu 31-130) is a new type of compound with a strong pro-cognitive effect in animal models and the potential to treat a number of neurological and psychiatric diseases.
In the phase II development programme, zicronapine has shown strong, positive anti-psychotic effects.
The programme consisted of a placebo-controlled study and an olanzapine-referenced study, which in total involved approximately 375 patients.
In the placebo-controlled trial, zicronapine showed clear dose-response and a statistically significant improvement in Positive and Negative Syndrome Scale (PANSS) score on both 7mg and 10mg.
In the olanzapine-referenced study, zicronapine showed comparable reduction in PANSS score.
From both trials it can be concluded that zicronapine was safe and well-tolerated.
In the olanzapine-referenced study the number of withdrawals was similar to the level of withdrawals in the olanzapine-group.