PhaseBio, a small biotechnology firm based in Malvern, Pa., is not loved by investors. Its shares are down 25 percent from their October 2018 initial public offering, and the company has a market capitalization of just $89 million. So it’s a bit of a surprise to see the company’s experimental drug highlighted in the New England Journal of Medicine.
The study, also being presented here at the annual meeting of the American College of Cardiology, tested PhaseBio’s drug, PB2452, as a way to reverse the effects of Brilinta, an AstraZeneca drug that is used to prevent blood from clotting in heart patients, including those who have received stents to prop open clogged arteries.
PB2452, an antibody, was originally being developed by AstraZeneca. That London-based drug giant, which was an investor in PhaseBio, licensed the medicine to the smaller company after the potential for PhaseBio’s original prospects dimmed, said PhaseBio chief executive Jonathan Mow.
The study tested the reversal agent in 64 healthy volunteers, 48 of whom received the PB2452. The other 16 were given placebo. All were given Brilinta first. In the patients given PB2452, the effects of Brilinta were reversed in five minutes, and the reversal lasted more than 20 hours.
“I think it has the potential to be really useful,” said Dr. Deepak Bhatt, of Brigham and Women’s Hospital, who conducted the study with funding from PhaseBio. He said he might be willing to use the drug right now (it is not yet approved) for a patient with a serious, life-threatening bleed. More data, he said, is needed in order to use it for patients who are on Brilinta and awaiting surgery.
That would probably be the bigger medical use for such a drug. Right now, surgeons are instructed to wait five days for Brilinta to stop working before doing a procedure like open-heart surgery. “If we can reverse these drugs, it’s not a huge indication, but it could be lifesaving,” said Dr. Steven Nissen, chairman of cardiology at the Cleveland Clinic. “It’s not somebody who is bleeding, it is someone who needs an operation.”
What investors probably don’t like is that even this indication may be very small. Brilinta has recently become a $1 billion-a-year seller globally, but it and another drug, Eli Lilly’s Effient, have failed to make much of a dent in the standard medicine doctors use: clopidogrel, a generic drug once known as the cardiac mega-blockbuster Plavix. PB2452 is also a drug that would be given only once.
It’s probably a small market. PhaseBio’s Mow argued that as much as 10 percent of Brilinta patients could be candidates for the reversal agent. But he also said that doctors might be likely to choose Brilinta more often once a reversal agent is available, and that this trend could accelerate after Brilinta loses patent protection in 2024. In the meantime, PhaseBio will move forward with conducting a 250-to-300-patient study aimed at securing regulatory approval from the Food and Drug Administration. Based on FDA guidelines, Mow said, approval could come based on the first 50 patients, with the rest of the study conducted after approval is granted.
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