FDA, Regulatory

PhaseBio touts ‘breakthrough’ badge for bloodthinner reversal agent licensed from AstraZeneca, shares leap

At PhaseBio, the game plan has been to hustle its Brilinta reversal agent, PB2452, down what it sees as a short path to approval, unlocking revenue that will then fund more expensive trials of its pulmonary arterial hypertension drug. With a new breakthrough therapy designation, execs are marching onward with boosted confidence.

The “breakthrough” badge was bestowed based on Phase I results in which PB2452 achieved “immediate and sustained reversal” of Brilinta’s antiplatelet effects. The biotech’s shares $PHAS surged 30%, reaching $16.4 pre-market.

Jonathan Mow

PhaseBio first licensed PB2452 in 2017 from AstraZeneca for $100,000 upfront, the maker of the blood thinner also known as ticagrelor. It’s designed for acute situations where patients are experiencing active bleeding or require urgent surgery — akin to what Portola did with Andexxa, an anti-anticoagulant that reverses rivaroxaban and apixaban.

That’s a departure from PhaseBio’s previous strategy, CEO Jonathan Mow told me ahead of its Series D announcement last year, which revolved around its tech. The elastin-like polypeptides platform creates therapeutic fusion proteins that undergo a fully reversible phase transition, thereby significantly extending their half lives.

In fact, PhaseBio said on the heels of the “breakthrough” news, it has licensed a long-acting, recombinant GLP-1 analogue dubbed PB1023 to ImmunoForge, which is especially interested in its use for sarcopenia. The deal doesn’t cover diabetes, obesity and NASH.

The platform tech is still being used in the development of PB1046, an in-house asset for PAH that’s designed for chronic use. But for now spotlight is on PB2452, which Mow considers an orphan first-in-class product in the cardiopulmonary space and which he predicts will enhance the safety profile of Brilinta, reinforcing its use and gradually expanding PhaseBio’s own market.

“PB2452, can be developed in a much shorter time period, and it will pay for us to develop PB1046,” he said earlier. “So even though it’s only in Phase I, we will get to the later stages of development much more quickly than we will with PB1046.”

He now has the FDA on his side to accelerate and facilitate the clinical progress.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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