When startup TFF Pharmaceuticals raised $14 million in a series A in 2018, its intention was to deploy its dry-powder drug-delivery technology toward making novel inhalable therapies for asthma, chronic obstructive pulmonary disease and other serious lung diseases. Then COVID-19 hit, and the company saw an opportunity to apply the platform to the emerging virus.
So, the Austin, Texas-based company teamed up with Augmenta Bioworks in Menlo Park, California, to develop an inhalable monoclonal antibody to treat COVID-19. In hamster models, the drug reduced viral load one day after infection with SARS-CoV-2, the virus that causes COVID, the companies reported (PDF) on the journal preprint site bioRxiv. They plan to start human trials next year, they said in a statement.
TFF is developing inhalable drugs based on a “thin freezing film” technology licensed from the University of Texas at Austin. It is focusing on biologics and small molecules that thus far have not been able to be formulated as inhalable drugs, and it has two in phase 1 trials: TFF for invasive pulmonary aspergillosis (IPA) and TFF TAC-LAC, a dry-powder version of tacrolimus, a commonly used immunosuppressive drug in organ transplants.
The COVID drug, dubbed AUG-3387, is a fully human antibody that TFF and Augmenta isolated and tested for its ability to bind to the SARS-CoV-2 spike protein. In cell studies, the antibody neutralized SARS-CoV-2 and the delta variant of the virus, the companies reported.
The researchers went on to administer a dry-powder version of the drug to hamsters one day after they were challenged with COVID-19. The viral load in the animals dropped in a dose-dependent manner, they found.
There are antibody treatments on the market now to treat COVID, including Regeneron's REGN-COV. But that and other authorized treatments have to be infused at healthcare facilities—a hassle TFF and Augmenta want to eliminate.
“While these [antibody] therapeutics provide a clear therapeutic benefit for the reduction of hospitalization, the route of administration continues to place a burden on the healthcare system,” the researchers wrote in the study. Thus, delivery … to patients in an outpatient setting without the need for specialized infusion centers would provide a clear advancement.”
The study from TFF and Augmenta came just days after Merck and Ridgeback Biotherapeutics announced that their oral COVID drug, molnupiravir, cut the risk of hospitalization or death by 50%. An advisory committee to the FDA plans to meet Nov. 30 to weigh an emergency use authorization for the drug, but some Wall Street analysts are already guessing it will be a blockbuster.
Bernstein analyst Ronny Gal estimated last week that the total global market for antivirals that can be taken by mouth will be worth $6 billion, even after COVID-19 shifts from a pandemic to an endemic virus.
TFF and Augmenta said they plan to develop AUG-3387 for two uses: to treat COVID-infected people who have not yet been hospitalized but face a high risk of dangerous complications and to prevent the disease in high-risk individuals.