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Germany’s Vivoryon raises €43m for Alzheimer’s drug trial

Results of European study expected in 2022

alzheimers

German biotech Vivoryon Therapeutics has raised €43m in a rights offering that will allow it to take its Alzheimer’s disease (AD) drug candidate PQ912 through a planned phase 2b trial in Europe.

The funds will be used to manufacture supplies of PQ912 for the trial, as well as carry out testing in around 250 patients in Europe, and to get a similar trial underway in the US. Results of the European study are expected in 2022.

PQ912 is a small-molecule inhibitor of the enzyme glutaminyl cyclase, which is up-regulated in the brains of Alzheimer’s patients and generates pyroglutamate amyloid beta, thought to be a particularly pathogenic form of the peptide.

The healthy fundraising comes hard on the heels of Biogen and partner Eisai’s decision to resurrect its amyloid-targeting drug aducanumab – which had been written off earlier in the year – in a move that has provided some much-needed support for the troubled amyloid hypothesis of AD.

That decision “provides new evidence for the positive implications of amyloid plaque reduction in slowing cognitive decline” as well as a positive read-across for other approaches targeting amyloid beta, such as Vivoryon's lead asset PQ912,” said Goetzpartners’ analysts Brigitte de Lima and Martin Piehlmeier in a research note.

They note that Vivoryon had been hoping to raise around €30m from its latest placement, so the final tally is a better-than-expected result – no doubt helped by Biogen and Eisai’s announcement – that has allowed the biotech to start its US development of PQ912 earlier.

“We are optimistic about the prospects of PQ912 in AD based on the molecule's differentiated mechanism of action and supportive phase 2a data,” say the analysts.

The phase 2a trial showed that the drug was able to inhibit the target enzyme and seemed to improve working memory, with a significant impact on the “one card back” memory test, they note.

The announcement of aducanumab’s demise as well as the failure of AC Immune and Roche’s crenezumab and other amyloid-targeting agents including Biogen/Eisai’s elenbecestat and Amgen/Novartis’ umibecestat this year alone have lent further ammunition to those arguing that the amyloid hypothesis should be abandoned once and for all.

Biogen and Eisai’s latest decision reverses that trend, although the two have already been accused of being over-optimistic of the chances of approval based on the data re-analysis by some analysts, who remain unconvinced by the totality of its data on the drug.

Vivoryon isn’t the only company backing the pyroglutamate amyloid beta target however. Eli Lilly is developing an antibody drug against it – called donanemab – which has reached the phase 2 testing stage.

“Backed by these financial commitments we are fully dedicated to continue our clinical development programme of PQ912 in patients diagnosed with early stages of Alzheimer’s disease, enabling initiation of the phase 2b in Europe and the US in parallel,” said Dr Ulrich Dauer, Vivoryon’s chief executive.

“Vivoryon’s focus is now on achieving the next milestones in our cornerstone programme in Alzheimer’s disease,” he added.

Article by
Phil Taylor

24th October 2019

From: Research

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