Biotech is just beginning to grapple with the disruptive effects of the coronavirus pandemic, which has prompted city- and country-wide lock downs around the world. One noteworthy announcement in the industry came late Monday, when a small biotech, Provention Bio, disclosed a delay to a key clinical trial.
Due to the coronavirus outbreak, Provention has paused efforts to enroll patients in a Phase 3 study of a drug it is developing for children with Type 1 diabetes. It's unclear when the study will restart, or what it will take for Provention to feel comfortable doing so without putting trial volunteers at risk.
"It's a multifactorial decision," CEO Ashleigh Palmer told BioPharma Dive in an interview. "We haven't established the criteria of that at this point."
Clinical trials are hugely important endeavors for biotechs. Meeting expected timelines and delivering positive results can bolster stock prices, enabling companies to raise the cash needed to move drugs further forward. Delays or trial stoppages create uncertainty that can make it more difficult to stay afloat — and stall potentially important new research.
But the public health threat the nation and world currently face could change the typical calculus for biotechs. Trials can stop early or get suspended for good or bad reasons, but they're usually related to whether a drug performs well or doesn't. Provention paused its trial, which has sites in the U.S. and Europe, to help slow the spread of the virus.
"Our first priority is patient and employee safety," Palmer says. "If we can't practice that, then we shouldn't be in this economic ecosystem."
Provention's delay is a possible sign of things to come as people across the globe enact social distancing to slow the virus. Indeed, since Provention halted its trial, three other biotechs - Arrowhead Pharmaceuticals, Addex Therapeutics and Iveric Bio - have followed suit.
Cantor Fitzgerald analyst Alethia Young noted there is "risk to many current clinical trials" underway, and expects other companies to experience "similar challenges or worse problems," such as people dropping out of trials or not complying with study protocols.
The National Institutes of Health sounded an alarm Monday as well, issuing new guidelines for conducting NIH-funded human studies that it said will likely create "delays to ongoing research." Evercore ISI analyst Umer Raffat added that there is "plenty of evidence that a serious slowdown in clinical trials is in the works," citing recent commentary from large clinical research organizations and outreach to academic institutions.
Much depends on how widespread the outbreak becomes, and how long it lasts.
Two major medical centers reached by BioPharma Dive for comment indicated that they're still working through how clinical studies will be impacted, and indicated the situation is fluid.
With his decision freshly made, Provention CEO Palmer spoke with BioPharma Dive about what went into pausing the trial, what comes next and what potential long-term implications the pandemic may have for biotech.
The following conversation has been edited and condensed for clarity.
How did the decision come together to halt the trial?
PALMER: At the end of last week, we began to see this escalate to the point where we thought this decision was prudent. This is about reacting to a state of emergency in all of the countries that we're operating in, especially in the U.S. Sites were reaching out to us and asking for guidance. And some sites have made the decision themselves — unilaterally across all of their clinical trials — for particular reasons. Given where we are, and where we were last week, this was absolutely the right decision.
Why was this particular trial one that would put people at risk of infection?
PALMER: Our patients are randomized when we identify them as having been recently diagnosed with Type 1 diabetes. That requires a significant screening process. And the therapy requires patients to come into an institution and spend 12 days consecutively in that hospital as an outpatient.
Things may be different [in a trial where] somebody who comes in once to a hospital, gets screened and sent home with some tablets and stuff, and then does patient-reported outcome on an electronic device for the next month.
Are you considering similar moves for other planned trials?
PALMER: Oh yeah, for sure. We have a study in celiac that is scheduled start at the beginning of the second half of this year. Obviously we'll be monitoring the situation closely there with our development partners [Amgen and Johnson & Johnson] to determine if that study starts up. But this is an unusual situation. It's very dynamic. I think everybody's hoping that it will have calmed down in the second half of this year and we'll be returning to businesses as normal.
What would make you feel things have normalized enough to restart the PROTECT trial?
PALMER: One would be much more comfortable if tests were more freely available to individuals who don't have symptoms, so that we can test incoming patient candidates and their immediate caregivers to ensure that there is no asymptomatic infection before they come in. It's a multi-factorial decision, and we really haven't established the criteria of that at this point. We've simply made the best decision we could, and then announced it immediately. We didn't have the luxury of preparing for this for a month and then announce it with all this stuff sorted out.
Despite those uncertainties, would you encourage your peers to follow suit?
PALMER: I'm not going to speak to other companies in their particular trials. You have to have a management team make the decision on a case-by-case basis. But I will say that any company should be making the right decision over economic considerations. Our privilege to serve in this industry demands that our first priority is patient and employee safety and wellbeing. 'First, do no harm.' If we can't practice that, then we shouldn't be in this economic ecosystem.
Even if things do go back to normal, do you expect there to be any long-term ramifications for clinical trials as a result of dealing with this outbreak?
PALMER: I think it will accelerate trends in the industry that were already taking place. Perhaps you can take blood samples and do a test at home, with telemedicine, or get patients to not have to go in to a hospital for a day in order to have a workup for a clinical trial. Not only do you provide efficiency and have an opportunity to evaluate patients in a more normal setting, but you avoid putting cost and inconvenience into the system.
So perhaps companies that provide those types of services and big pharmaceutical companies would catalyze the acceleration of the acceptance of those types of approaches.
Editor's note: This article was update to include mention of trial delays announced by Arrowhead Pharmaceuticals, Addex Therapeutics and Iveric Bio.