TFF Pharmaceuticals, a company specializing in development and commercialization of drug products using its thin-film freezing (TFF) technology, has entered into an exclusive licensing agreement with Union Therapeutics. The collaboration will focus on using the TFF technology platform in combination with niclosamide for COVID-19 therapies.
Under the terms of the agreement, Union holds the option to obtain a worldwide exclusive license of TFF Pharmaceuticals to its TFF technology to be used in the field of niclosamide, including oral and inhalation versions. The agreement covers potential COVID-19 treatments, in addition to other niclosamide-based therapies.
Subject to Union’s exercise of its option, the company has agreed to pay TFF Pharmaceuticals potential development, regulatory and sales-related milestone payments of up to $210m. Union will also pay TFF tiered single-digit royalties on product sales.
Additionally, the two companies will work together on efforts to secure government support (such as contracts, grants, etc.) with the goal of funding development of niclosamide-based products for the treatment of COVID-19.
“We are very excited to be entering into this agreement with UNION therapeutics, a company that has had an extensive history working with niclosamide and the compound class in a number of therapeutic areas,” said Glenn Mattes, president and CEO of TFF Pharmaceuticals. “We believe this agreement will help speed up efforts to investigate the promising use of niclosamide for potential COVID-19 therapies using our breakthrough TFF technology to provide a viable therapeutic option with a new delivery method.”
Niclosamide is an oral anthelminthic drug, first approved by the US Food and Drug Administration (FDA) for human applications in 1982. Most recently, the drug has been identified as a multifunctional drug, with potential to be repurposed to treat a variety of viral infections such as severe acute respiratory syndrome coronavirus (SARS-CoV), Middle East respiratory syndrome coronavirus (MERS-CoV), Zika virus (ZIKV), and others, given its inexpensive cost and low in-vivo toxicity profile as an FDA-approved drug in clinical use.
While niclosamide has been shown to exhibit potent antiviral activity against SARS-CoV-23 and totally eliminated viral antigen synthesis at a concentration of 1.56 μM, the drug reportedly has limited aqueous solubility, low absorption and low oral bioavailability, creating challenges for its development as a potential anti-viral therapy. The TFF technology reportedly has demonstrated improvements to the solubility of the drug’s oral and dry-powder forms.
“We’ve made significant progress in the past three months in our efforts to examine niclosamide for potential COVID-19 applications,” said Mattes. “This agreement will further those efforts as well as provide a number of opportunities to synergize both our company’s drug portfolios in new, potentially more effective combinations for eventual commercialization.”
UNION has worked with niclosamide and the related chemical class for over six years and is currently conducting a Phase 2b study with niclosamide in atopic dermatitis patients.
“Our hope is for the consolidated efforts under the agreement to enable UNION to leverage our extensive knowledge of niclosamide and further accelerate the development of treatment options to a broader range of COVID-19 patients,” said Union’s chief scientific officer and cofounder Morten Sommer. “We look forward to working with the team at TFF Pharmaceuticals to leverage the TFF technology platform in bringing new treatment options to COVID-19 patients.”