Nesreg schreef op 14 juni 2019 15:26:
Vantage - March 20, 2019 - Madeleine Armstrong
Probiodrug wins a market cap-sized grant for Alzheimer’s trial
Probiodrug grabs $15m, but it will need more to fund phase IIb development of its Alzheimer’s candidate, PQ912.
White silhouette of head, as a jigaw puzzle with a piece missing, against black backgroud
Raising money is nothing new for biotech companies. But in scoring a grant worth nearly as much as its market cap, Probiodrug has something to write home about. Investors sent the German company’s shares up as much as 36% today on news of a $15m award from the US NIH; yesterday the group was valued at €16m ($18m).
Probiodrug might now finally be able to start a US phase IIb trial of its Alzheimer’s disease candidate PQ912, but it is not out of the woods just yet. The grant will not fully fund the study and, at last count, the group had just €5m in the bank.
More money more problems
Probiodrug’s chief executive, Ulrich Dauer, told Vantage that the company did not want to start the trial without having the funds to finish it, or at least get to a “reasonable point”.
That reasonable point could be the end of a dose-escalation phase, he suggested. Probiodrug has not nailed down the exact design of the trial, but the current plan is to start with a PQ912 dose of 150mg, before upping this to 300mg, and then 600mg. The company would then pick the highest tolerated dose to take into the chronic part of the study.
With this in mind, the chief exec said it was premature to speculate on the minimum amount of money Probiodrug would need to start the trial. Mr Dauer also would not disclose how much the $15m NIH grant might cover, and how much Probiodrug would have to fund itself, although he did admit that the company could be on the hook for a substantial amount.
The study is slated to enrol around 460 patients in the US and Canada with mild cognitive impairment or mild dementia due to Alzheimer’s, who would receive PQ912 or placebo for 18 months. Phase II Alzheimer's disease trials typically cost around $23m, according to EvaluatePharma Vision, though as Probiodrug is talking about a larger phase IIb study, the final bill would probably be significantly higher.
This makes the NIH funds start to look like a drop in the ocean, particularly when considering that Probiodrug also plans to start enrolling patients into a phase IIb European trial, Saphir 2, by the end of this year.
Current funds are only expected to keep Probiodrug going until the third quarter of 2019.
Searching for a partner
The company therefore needs to find more cash, with partnering or an equity raise at the top of the agenda, the chief exec said.
He maintained that there was still interest from potential collaborators, despite the mounting casualty list of Alzheimer’s projects, most recently Roche’s anti-beta amyloid antibody crenezumab.
Although Probiodrug is also targeting amyloid, the company might benefit from taking a slightly different approach. PQ912 is a small-molecule inhibitor of glutaminyl cyclase, the enzyme that converts beta-amyloid into what the company calls the toxic pGlu-Abeta form.
The most similar project in development is Lilly’s LY3002813, an antibody that binds directly to pGlu-Abeta. Notably, Lilly kept faith with this project when it cut back its Alzheimer’s pipeline last year, something Mr Dauer said he was pleased about because it validated Probiodrug’s strategy (Eli Lilly backs away from Bace but not from novel Alzheimer’s targets, 14 November 2018).
Still, LY3002813, which had once been behind PQ912, is pushing ahead fast. LY3002813 is in a phase II trial, Trailblazer-Alz, which is due to complete next year, according to clinicaltrials.gov.
The NIH money is a start, but Probiodrug needs more than $15m if it wants to keep going with PQ912, let alone keep up with a bigger rival.
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