Ocugen (OCGN -0.56%) had hoped to move forward quickly with a U.S. late-stage clinical study of its COVID-19 vaccine candidate, Covaxin. However, those plans hit a speed bump when the Food and Drug Administration (FDA) placed a clinical hold on the study. In this Motley Fool Live video recorded on Dec. 1, 2021, Motley Fool contributors Keith Speights and Brian Orelli discuss how worrisome this news might be for Ocugen.
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Keith Speights: All right, we mentioned this earlier at the beginning of our segment, Brian, but the FDA has placed a clinical hold on Ocugen's planned U.S. late-stage study of COVID vaccine Covaxin.
First of all, why did the agency take this step and place this clinical hold? Secondly, how worrisome and concerning is this latest bad news for Ocugen?
Brian Orelli: Yeah, before starting a clinical trial, companies submit what's called an Investigational New Drug application, or IND, to the FDA, and that gets them permission to start the clinical trial. So Ocugen did that last month. And then the company wants to run a bridging study to show that Americans generate antibodies to the coronavirus at approximately the same level as seen in people in the clinical trial that was run in India that showed that the vaccine actually had efficacy at decreasing infections.
They're trying to do a bridging study -- so A equals B, and B equals C, so A equals C, is the idea there. After an IND is submitted, then the FDA either clears the IND and lets the clinical trial go on, or it puts a clinical hold on the project if there's issues with the data that the company submitted to support the proposed clinical trial. So that's what happened here.
In theory, this isn't necessarily as bad as a clinical hold that you might see for an ongoing clinical trial, where there's a new safety signal that causes the FDA to put the brakes on the clinical trial. It could be as simple as Ocugen didn't submit the right pre-clinical animal data showing that the drug is safe, and if Ocugen's partner, Bharat Biotech in India, has that data, then it could be a really easy fix.
Worst-case scenario is that they have to generate the data, and that obviously would create a big delay. I wonder if the agency is concerned about clinical trial design. This usually isn't an issue because companies usually hold pre-IND meetings with the agency to go over their clinical trial design, so by the time that you're actually submitting the IND, the FDA knows what you're going to say, and they've told you, "Yeah, that's good," or "No, you should do it this way," and then you do it that way.
But I haven't seen anything from Ocugen that said they held a pre-IND meeting with the FDA. That doesn't mean they didn't, because a lot of times, companies just don't bother to say that, because it's routine. But if they didn't, then maybe that could be the problem too, and then maybe they have to design a different clinical trial.
Unfortunately, Ocugen didn't give us any information on what the issues are with the clinical hold. That maybe because the company doesn't know -- as of Friday, they were waiting for formal written communication from the agency. And of course, the company is also trying to get Emergency Use Authorization for kids from 2 to 18, so depending on the nature of the deficiencies the FDA sees for the bridging study, [this] could potentially affect that application as well.
Speights: It sounds like, Brian, you're saying, right now, not a huge reason to worry, but there could be more reason to worry depending on what unfolds here.
Orelli: Yeah, there's a lot of unknowns definitely.