UNION therapeutics has acquired an option to a worldwide, exclusive licence to TFF Pharmaceuticals‘ Thin Film Freezing (TFF) technology, in combination with niclosamide, covering oral and inhalation formulations, potentially for COVID-19, as well as other niclosamide-based therapies. If UNION exercises its option, it will pay TFF Pharmaceuticals development, regulatory and sales-related milestones of up to US$210 million (£160 million) plus tiered single-digit royalties on product sales.
UNION has recently completed dosing of healthy volunteers with its UNI911 (inhaled niclosamide) product for COVID-19, and is currently conducting a Phase IIb study with niclosamide in atopic dermatitis.
The two companies are also collaborating on securing government support with the aim of funding the development of niclosamide-based products for the treatment of COVID-19.
Glenn Mattes, President and CEO of TFF Pharmaceuticals, believes that this agreement will “…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, an approved oral anthelminthic drug included in the WHO’s list of essential medicines, has exhibited antiviral activity against SARS-COV-2. However, it has limited aqueous solubility, as well as low absorption and oral bioavailability, creating challenges for its development as an antiviral. TFF said its thin film technology had improved the solubility of oral forms of niclosamide as well as to dry powder forms of the drug for delivery directly to the lungs.
In April 2020, it was announced that a novel inhaled formulation of niclosamide was under development at the College of Pharmacy at the University of Texas at Austin (US) for the treatment and prevention of serious COVID-10 symptoms.
Link to Press Release