State-funded testing of COVID-19 treatment approved to start 3,000-person clinical trial

And it’s ready to take the next step in a clinical trial for a new drug that could make that happen.

MUSC will be looking for up to 3,000 South Carolinians to participate statewide via telemedicine.

In 2022, legislators agreed to set aside $27.7 million from the state’s share of federal pandemic aid for MUSC to test the drug as a treatment for COVID-19 symptoms. But they put a clause in the budget requiring separate approvals for each step in the process.

It was the Palmetto State’s first foray into funding pharmaceutical research. Officials hoped the research will help grow pharmaceutical and bioscience industries in the state, bringing more high-paying jobs and attracting highly educated experts in those fields.

“When we brought this forward, we knew as a state that this had the potential to position South Carolina as a place where drug manufacturers could come to do the whole entire testing from that initial discovery all the way up through manufacturing,” MUSC Chief Innovation Officer Dr. Jesse Goodwin told members of a legislative oversight committee Tuesday. “It has great potential for the health and welfare of our citizens, and really a great potential to really put South Carolina on the map from a drug manufacturing perspective.”

State-funded testing of COVID-19 treatment needs SC volunteers

Legislators previously gave permission for MUSC to spend $13.1 million for the clinical trial on behalf of drug developer OCI Biotech Limited, which has operations in Europe.

That first phase was about making sure the drug was safe for human consumption.

On Tuesday, legislators granted the school permission to spend the remaining $14.6 million on a more expansive human trial to prove the drug will indeed work as expected.

The 3,000-person trial marks the final step toward gaining U.S. Food and Drug Administration approval.

When patients call in to MUSC’s telehealth network with symptoms of flu, COVID-19 or respiratory syncytial virus (RSV), doctors will diagnose them. For those 10% of patients whose respiratory symptoms get worse, causing lung infections and breathing problems, the hospital system will give them the option of participating in the trial.

“We’re interested in those that have deep lung inflammation that could end up with them being hospitalized,” Goodwin said. “This could be a life-saving treatment for them.”

MUSC and its partners will write prescriptions for the drug, known as Nebtula, and mail out wearable medical devices to patients so doctors can monitor how well the drug works.

The drug isn’t designed to eliminate symptoms entirely, Goodwin said, but it “tamps it down and prevents it from going off the rails.”

Clinical trial participants will either receive the drug every 12 hours, every 24 hours interspersed with a placebo, or a placebo every 12 hours. MUSC doctors will monitor those participants for six months. The trial is expected to last four years.

Should the drug eventually receive FDA approval, it’s expected to be manufactured in South Carolina. The medical school’s Zucker Institute for Innovation Commercialization also holds intellectual property and other revenue-sharing agreements with OCI, though the terms of those agreements were not immediately available.

But first and foremost, according to MUSC, are the anticipated health benefits for South Carolinians suffering from respiratory viruses.

South Carolina, like many states without a city that ranks among the largest nationwide, has lagged in access to clinical trials. The hope is that proving MUSC can run one could bring more to the state in the future.

How it started

While the drug is intended to combat COVID-19, its journey to South Carolina started long before the pandemic.

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According to MUSC, the scientific team at OCI spent 10 years discovering and developing the treatment for lung inflammation.

It does not kill the COVID-19 virus but rather treats the respiratory symptoms. That means it could also help in managing similar symptoms associated with other viruses.

“COVID-19 is not as significant of an issue as what it was back in 2020,” Goodwin said. “But influenza A and B certainly still are. RSV still is.”

When it came time for OCI to move from lab-based studies to human testing, the group started looking for partners.

That brought OCI to Nephron Pharmaceuticals in Lexington County, which makes generic drugs to treat a multitude of respiratory illnesses.

Nephron received shipments of OCI’s formula, which starts as a powder made at one of OCI’s labs in Europe. Nephron liquified the powder, and the liquid drug is administered through a nebulizer, which turns it into a mist breathed in by a patient.

After teaming up with Nephron, OCI then tapped MUSC to run its clinical trials. And Velocity Clinical Research — headquartered in Durham, North Carolina — with offices in Spartanburg, Columbia, Anderson, Greenville, Gaffney, and Union ran the smaller, first phase trial.

For this next phase, Nephron will continue making the drug. It will receive $1.1 million in state funding to do so.

Total CRO, a clinical research organization, will run the study’s database, receiving $2 million in state funding. PulManage, Inc., will monitor patients through their wearable devices, receiving $2.9 million.

OCI will get about $600,000. But the lion’s share of the money — $8 million — stays with MUSC.

Goodwin did tell legislators that there is always the possibility the FDA will want more data or won’t grant approval at the end of the trial. But the agency has so far been responsive, giving the researchers hope.

It only took federal drug regulators a month to grant MUSC permission to move ahead with this next phase.

“That time frame is extremely short for an FDA submission and feedback,” Goodwin said. “I actually feel quite positive we have the permission that we need to go all the way forward to the end.”

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