H. Lundbeck A/S (Lundbeck) announced 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 (7.5 mg/day) or risperidone (5 mg/day) treatment in a 1:1 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 7 and 10 mg. 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.
About the clinical phase II study
In the placebo-controlled clinical phase II study approximately 280 patients from 11 countries suffering from schizophrenia were enrolled. Eligible patients have been randomised in a 2:1 ratio to blinded treatment with either zicronapine (3, 5, 7 and 10 mg/day) or placebo for 8 weeks. The primary focus of this trial was safety and tolerability measured by adverse events, clinical safety laboratory tests and metabolic parameters. Secondary outcome measures included PANSS and Clinical Global Impression - Severity/Improvement (CGI-S/I) scores.
In the second clinical phase II study approximately 93 patients were enrolled from nine countries. Eligible patients were randomised to treatment with either flexible doses (5-7 mg/day) of zicronapine or flexible doses of olanzapine (10-15 mg/day) for 12 weeks. The efficacy and the safety of zicronapine were explored in comparison to olanzapine. The primary outcome measures included the PANSS score. Secondary outcome measures included CGI-S/I and Calgary Depression Scale for Schizophrenia (CDSS) scores.
The two studies were exploratory and therefore not powered to show clear statistical differences. However, in the studies zicronapine did show clear statistical significant separation from placebo at 7 and 10 mg and very convincing efficacy and safety data when compared to olanzapine justifying further development.
About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical company highly committed to improving the quality of life for people suffering from central nervous system (CNS) disorders. For this purpose, Lundbeck is engaged in the research and development, production, marketing and sale of pharmaceuticals across the world. The company's products are targeted at disorders such as depression and anxiety, schizophrenia, insomnia, epilepsy and Huntington's, Alzheimer's and Parkinson's diseases.
Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark. Today Lundbeck employs approximately 5,900 people worldwide. Lundbeck is one of the world's leading pharmaceutical companies working with CNS disorders. In 2009, the company's revenue was DKK 13.7 billion (approximately EUR 1.8 billion or USD 2.6 billion).