You don’t often hear the word “derisked” in a conversation about an experimental therapy for Alzheimer’s, but that’s the word Alzheon CEO Martin Tolar chooses to describe where he’s at now with a new/old therapy for the memory-wasting ailment.
After raising some $20 million in bridge financing, Tolar’s small team journeyed to the Alzheimer’s conference in Toronto to spotlight the latest pharmacokinetic data they’ve put together on ALZ-801, a prodrug of tramiprosate, otherwise known as Alzhemed, which like most Alzheimer’s drugs imploded in a Phase III study. And now he tells me that the biotech is well along the path to a new financing round that can support the $100 million budget needed to pay for two Phase III studies, with a potential IPO in the business plan.
The Framingham, MA-based Alzheon team is focusing on a strategy very similar to the one adopted quite successfully — so far — by Axovant $AXON: Taking a failed drug and relying on existing data to prove it’s both safe and potentially effective for a specific population of patients. Alzheon, though, is also pursuing the amyloid beta hypothesis, which has defeated every drug thrown at it so far in a pivotal study.
Tolar, the former BD chief at Pfizer, knows full well that the landmark failures in this field, including bapineuzumab, cost around $400 million to pull off. But he says Alzheon will only need to recruit 500 patients each for its two Phase III trials, focusing on a genetically-defined AD population of APOE4/4 homozygotes; “patients known to have risk factors for amyloid pathology.”
The big money has already been thrown at Alzheon’s drug, says Tolar. “We’re adding on top of it,” he says, “with a good understanding of the dose.”
In the Toronto conference, he highlighted the company’s progress on an improved oral, once-daily dose that can be taken into Phase III.
That’s the story that Tolar believes will complete his big financing round, which will concentrate on crossover investors who can help push through an IPO, at the right time.
“I feel we’re already IPO ready,” says the CEO.
It may not be derisked, but after others have blazed the trail, it seems like a viable path forward.
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