Lundbeck (CPH:LUN) has started the first of several planned Phase III trials of its candidate against treatment-resistant schizophrenia, Lu AF35700. The candidate is a key component of the turnaround strategy initiated by Kåre Schultz, who has shed other pipeline prospects in order to up Lundbeck's bet on Lu AF35700 since taking over as CEO last year.Lundbeck CEO Kåre Schultz
Copenhagen, Denmark-based Lundbeck is kicking off the pivotal trial program of the experimental drug with a Phase III study that will recruit 1,000 patients across 15 countries. In the study, Lundbeck will administer one of two doses of Lu AF35700 to patients with treatment-resistant schizophrenia. If the drug works as Lundbeck hopes, participants' scores on the Positive and Negative Syndrome Scale (PANSS) will improve following 10 weeks of treatment. The primary PANSS endpoint is being supplemented with Clinical Global Impression – Severity of Illness scores and Personal and Social Performance Scale data.
Lundbeck expects to be running the study for the next three years, during which time it will roll out additional trials with a view to gathering data on more than 2,000 people with treatment-resistant schizophrenia. The size of the bet is proportional to Lundbeck's assessment of the scale of the unmet need and opportunity associated with treatment-resistant schizophrenia. "Today there is only one therapy approved for patients with treatment-resistant schizophrenia, and its use is severely limited by its problematic safety profile," Lundbeck R&D Chief Anders Gersel Pedersen said in a statement.
The lack of many existing therapies is indicative of the difficulties treatment-resistant schizophrenia has posed to drug developers. Yet Lundbeck has expressed confidence in Lu AF35700. Within three months of joining from Novo Nordisk ($NVO) as CEO, Schultz cut early stage programs to free up the money Lundbeck needed to take Lu AF35700 through Phase III unpartnered. The decision was based on Lu AF35700's affinity to D1, a characteristic that Lundbeck thinks will enable it to improve health outcomes in patients who are resistant to D2-targeting drugs.
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