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Lundbeck drops Parkinson’s drug acquired in €905m deal

Disappointment after drug failed in a mid-stage clinical trial

Parkinson's disease

Lundbeck’s acquisition of Pexton Pharma and its Parkinson’s disease candidate foliglurax has ended up being a bust, after the drug failed a mid-stage clinical trial.

The Danish drugmaker said it had decided to terminate development of the first-in-class, oral glutamate mGluR4 positive allosteric modulator – which was Pexton’s only clinical-stage programme  when it was bought in 2018 – after the drug missed all its objective in the phase 2 study.

The AMBLED study did not show a statistically significant reduction compared to placebo in ‘off’ time – periods when drugs to control the symptoms of Parkinson’s like muscle stiffness and slow movements aren’t working well.

That was the primary endpoint in the study, and foliglurax also missed the mark on a key secondary measure – it was unable to achieve an improvement of dyskinesia, involuntary muscle movements that are a symptom of the disease but also a side effect of drugs like levodopa.

Lundbeck paid €100m upfront for Merck Serono spinout Pexton and foliglurax two years ago, with another €805m tied to  development and sales milestones.

The deal was signed by former chief executive Anders Götzsche, who ran the company on an interim basis after former CEO Kåre Schultz was poached by Teva and before current CEO Deborah Dunsire was appointed.

Lundbeck is already a big player in neurology and psychological diseases, but has seen its pipeline hit of late with a series of disappointing results, including the failure of Alzheimer’s candidate idalopirdine and Lu AF35700 for treatment-resistant schizophrenia.

It has added to its pipeline under Dunsire with a $1.95bn takeover of Alder Biopharma, adding migraine prevention therapy Vyepti (eptinezumab) – which is launching in competition with rival drugs from Amgen, Eli Lilly and Teva – as well as a $400m purchase of Abide Therapeutics.

The acquisition of Abide added a drug for Tourette’s syndrome and neuropathic pain called ABX 1431 – re-christened Lu AG06466 – and there has been some bad news on that front too.

At the end of last week, Lundbeck said the monoacylglycerol lipase (MGLL) inhibitor had failed a phase 2a trial in Tourette’s, a neurological movement disorder that causes tics and sometimes involuntary vocal outbursts.

The company has decided to end development of the drug in Tourette’s, more bad news for patients with the disorder after Teva’s deutetrabenazine candidate hit the buffers in late-stage trials last month.

However, it says it will press on with trials of Lu AG06466 in “other indications in neurology and psychiatry”.

Article by
Phil Taylor

30th March 2020

From: Research



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