FDA and VirTech Bio Reach Agreement on Phase I Trial Design for OxyBridge™

At a second Pre-IND meeting with the US Food and Drug Administration in March 2024, VirTech Bio received agreement on the design of the Phase I clinical trial for OxyBridge™, its hemoglobin-based oxygen carrier for hemorrhagic shock.

The meeting, the company’s second with the agency, followed an initial Pre-IND meeting in October 2020 that set out the chemistry, manufacturing and controls (CMC) requirements and safety studies required before a first-in-human or Phase I clinical trial. The meeting delivered four outcomes, each of which moves OxyBridge™ closer to its Phase I study.

1. The viral clearance capacity of the manufacturing process was reviewed and surpassed requirements.
2. The protocols for the large-animal studies that precede a human trial were agreed.
3. The Phase I clinical trial design was agreed.
4. A clear path forward: the FDA raised no additional requirements to address the historical concerns about hemoglobin-based oxygen carriers, the extravasation, vasoconstriction and blood-pressure effects that ended earlier generations of the technology. OxyBridge™ was designed from the outset to overcome those failures, and the regulator asked for nothing beyond the standard IND-enabling package to address them. For a technology whose history is defined by those three problems, that is a significant signal.

Pre-IND meetings are how a company and the FDA agree what has to be demonstrated before proceeding to a first-in-human study and what that trial has to show before it begins. They clarify the requirements that must be met before the FDA will authorize a trial. That authorization comes in response to an Investigational New Drug application, which follows the IND-enabling preclinical studies that can now be planned. The major work ahead is to bring the manufacturing process up to cGMP standards to meet the FDA’s CMC requirements.

“The question hanging over every hemoglobin-based oxygen carrier is whether the regulatory body believes you have solved the concerns that ended the last generation. Leaving that meeting with the trial design agreed and no additional requirements related to those concerns validated our approach,” said Dr. Dallas Hack, CEO of VirTech Bio.

“What I took from the meeting was clarity. The FDA told us what it needs to see before a first study in humans, and nothing on that list was a surprise. That is as good an outcome as a Pre-IND meeting can give,” Dr. Hack added.