Lundbeck/Otsuka’s Results For 5HT6 Antagonist In Alzheimer’s Clears Path For Phase III Trials
This article was originally published in PharmAsia News
Executive Summary
Lundbeck announced Jul 17 positive Phase II results for Lu AE58054 as an add-on to donepezil for Alzheimer’s disease, and a Phase III trial with partner Otsuka will go ahead as planned.
Otsuka and Lundbeck announced statistically significant improvement in cognitive function in Alzheimer’s disease in patients with Lu AE58054 as an add-on to donepezil compared to donepezil alone. The 278 patient Phase II trial started in December 2009 and finished in November 2011, with sites in Australia, Canada, Czech Republic, Germany, Italy, Poland and Spain, according to clinicaltrials.gov. Lundbeck and Otsuka announced the positive results at the Alzheimer’s Association International Conference in Boston.
Otsuka and Lundbeck announced they would co-develop and co-commercialize Lu AE58054, a selective 5HT6 receptor antagonist, in March. Otsuka told PharmAsia News it will be a full partner in the global Phase III development, which is expected to begin in the second half of the calendar year. Otsuka agreed to pay $150 million upfront and up to $675 million in regulatory and sales milestones for Lu AE58054, which is believed to have potential for other central nervous system indications. The two companies are co-developing two other products, with an option for two more depending on Phase II results (Also see "Otsuka And Lundbeck Team Up On Third Neuro Compound" - Scrip, 28 Mar, 2013.) (Click here for more
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“Phase II clinical data show statistically significant improvement for Lu AE58054 as add-on to donepezil” – Otsuka press release (07/17/2013)