In the hunt for COVID-19 drugs, Gilead Sciences' remdesivir remains the sole pharma product authorized in the U.S. But it's reserved for hospitalized patients, leaving those with mild or moderate disease in the lurch.
A research team out of Texas is looking to change that. It's using its thin film freezing technology to create a powdered formulation for use in an inhaler. The approach could vastly expand patient access to the drug—if the California-based biopharma bites.
Researchers at The University of Texas at Austin developed its dry powder, inhaled version of remdesivir—now only available in IV form—in an effort to reach patients who aren't hospitalized. The inhaled formulation could deliver patients a lower-cost, lower-dose version of the drug that tackles the disease in its early stages and targets COVID-19 directly in the lungs, the team said.
Led by department head Robert O. Williams III, Ph.D., a team at the school's Division of Molecular Pharmaceutics and Drug Delivery used its thin-film freezing technology to develop the dry powder formula.
The rapid freezing technology turns drugs that don't easily dissolve in water into a "brittle matrix powder"—a fluffy powder that's ideal for pulmonary administration, Williams said in an interview. The final product is amorphous, not crystalized, which means it aerosolizes and dissolves easily in the lungs, Williams added.
That dry powder formulation could have an edge over other inhaled COVID-19 fighters in the works, partly in thanks to its purity, the team figures. The thin film freezing technology cuts out the need for inactive ingredients, so the final product is a near-100% remdesivir powder, Williams said.
Critically, a dry powder formulation would allow remdesivir to strike COVID-19 directly in the lungs, the primary infection site in patients with respiratory symptoms, and boost local antiviral activity, Williams' team thinks.
Plus, the researchers designed the dry powder formulation to work with a commercially available inhaler, potentially cutting the cost of delivery devices eventually used to administer it.
As it stands, remdesivir is given via intravenous infusion, and it's only authorized to treat patients hospitalized with severe symptoms. Gilead is working on its own inhaled formula for use in a nebulizer, hoping to expand its use to patients with moderate disease.
Dry powder remdesivir, deliverable at lower doses through commercially available inhalers, could reach patients at early stages of illness and potentially keep them out of the hospital, Williams' team thinks. It could lighten the load on overburdened healthcare systems, too.
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Plus, the treatment option might be easier on patients' wallets. Gilead's IV version bears a sticker price of $3,120 for the five-day course most patients currently receive. Because the dry powder formulation curbs the need for inactive ingredients, the API itself would account for much of the cost, Williams said.
But first, the team would need to convince Gilead that its research is worth the investment.
Williams' team set to work independently, but it hopes its research will provide UT with an opportunity to pitch its inhaled formulation to the Foster City, California-based biopharma.
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But Gilead has its own inhaled remdesivir in the pipeline. Last month, the company kicked off a phase 1b trial testing the safety of a nebulized remdesivir solution in 60 healthy volunteers. Like the UT team, Gilead argued that delivering the antiviral directly to the lungs could yield better outcomes for early-stage COVID-19 patients, preventing hospitalization and possibly cutting down on side effects.
Meanwhile, another Austin local snagged a license for UT's freezing tech. TFF Pharmaceuticals, an early-stage biotech, is using thin film freezing technology to develop flu vaccines, monoclonal antibodies and other novel drug formulations. In August, Denmark's Union Therapeutics snagged an option for a worldwide license to a dry powder version of tapeworm med niclosamide—made using TFF's thin-film freezing tech—for potential treatment of COVID-19 and other diseases.