As drugmakers scramble to develop treatments to fight COVID-19, some have looked to repurpose existing therapies. Now, one early-stage biotech is teaming up with a Danish drugmaker to advance an inhaled version of a tapeworm med—approved since 1982—that could strike the disease before it has a chance to progress past the lungs.
Denmark's Union Therapeutics in August snared the option for a worldwide exclusive license of TFF Pharmaceuticals' dry powder niclosamide—a tapeworm med that has shown promise against COVID-19—made using the Austin, Texas-based biotech's thin-film freezing technology.
Union has pledged upward of $210 million for potential development, regulatory and sales milestones as well as single-digit royalties, the companies said in a release. In return, it will receive dry powder and oral formulations of niclosamide straight from TFF, which prefers to keep its patented thin-film freezing platform close to the vest, TFF's CEO Glenn Mattes said in an interview. Union will be on the hook for clinical development duties and potential marketing if the drug wins a green light.
The companies will collaborate to secure government funding for the treatment as a potential COVID-19 therapy, with TFF pursuing fast-tracked approval in the U.S., Dale Christensen, director of clinical development at TFF, said.
Stateside, the company is plotting an accelerated trial to pin down safety and dosing information; TFF aims to study a single ascending dose followed by multiple ascending doses of both its oral and inhaled niclosamide formulations in healthy adults. Once that trial wraps, the company aims to move into trials in COVID-19 patients, ideally in about eight to nine months, Christensen said.
Meanwhile, Union, which boasts six years of niclosamide experience in other treatment fields, kicked off its own clinical study of an inhaled formulation earlier this year. That compound—an optimized salt form of the drug—is currently in phase 1 trials for use as an inhaled treatment for COVID-19.
Union hopes the collaboration with TFF will broaden its current niclosamide offerings, not only in COVID-19, but in other diseases, too. Plus, the team-up could help usher in the global rollout of a drug for earlier-stage COVID-19, filling a gap in the treatment options that have so far been authorized.
“Like Union, TFF has been working with niclosamide for an extended period of time and has taken an interesting approach to the formulation of niclosamide for COVID-19," Rasmus Toft-Kehler, CEO and co-founder of Union, said. "This will allow us to maximize the likelihood of getting the best possible product to as many COVID-19 patient segments in the shortest possible time frame."
That "interesting approach" is the product of TFF's patented thin-film freezing platform. Developed by the Division of Molecular Pharmaceutics and Drug Delivery at the University of Texas, Austin, the rapid-freezing technology improves the absorption rate of poorly water-soluble drugs, translating into the development of dry powder drug formulations especially well-suited for inhalation. What's more, dry powder formulations created with the thin-film freezing platform have strong aerodynamic properties, allowing drug particles to reach as much as 75% of the deep lung—an enticing target for diseases like COVID-19.
By delivering a treatment like niclosamide straight to a patient's lungs, TFF's thin-film formulations could quash COVID-19 before the disease has the chance to spread to other parts of the body.
"Only late in [COVID-19] does the virus start escaping the lungs and get into the blood," Christensen said. "It makes sense to provide the drug to the lung, where the virus is specifically replicating. It's far easier to throw a bucket of water to douse a campfire instead of waiting to have to put out a forest fire."
Beyond the Union deal, TFF thinks its thin-film freezing technology could have major implications for the development of other COVID-19 treatments, and even vaccines and diagnostics.
The technology can be used to create room temperature-stable versions of vaccines, which could allow distributors to break the cold chain, Christensen said. Plus, thin-film freezing can be used to make absorbable antibody formulations.
TFF has already forged three separate deals to expand its thin-film freezing tech across multiple treatment fields, including a partnership in the cannabinoid space, a tie-up with the University of Georgia for a broad-spectrum flu vaccine and a deal with the U.S. Army to develop two specific monoclonal antibodies as antiviral countermeasures, Mattes said.