Programs
Our Pipeline
Formulation
Internal Pipeline
Our initial pipeline focus in lung-directed, inhaled drugs leverages our expertise in respiratory medicine delivery and the ability of our platform to improve patient outcomes by offering a targeted option.
Voriconazole Inhalation Powder (TFF VORI)
TFF VORI is a next-generation, direct-to-lung, inhaled dry powder formulation of voriconazole in development for the treatment and prevention of invasive pulmonary aspergillosis (IPA), a severe fungal pulmonary disease. Voriconazole is recommended as the first-line treatment for IPA, but in its oral form is associated with significant drug-drug interactions and toxicities. Our formulation reduces the risk of systemic exposure and drug-drug interactions and yields better efficacy with a lower dose. The therapy can be delivered via a dry powder inhaler to enable ease of administration directly to the lung.
Tacrolimus Inhalation Powder (TFF TAC)
TFF TAC is an inhaled dry powder version of tacrolimus, an immunosuppressive drug used in transplant medicine. Tacrolimus is currently the second most commonly administered immunosuppressive drug used in solid organ transplants, despite many challenges when used for extended periods. Orally delivered tacrolimus can cause toxicity in the kidneys, particularly when used in high doses, and even high doses of tacrolimus lead to low concentration in the lung where the therapy is most needed.
TFF TAC specifically targets lung tissue, yielding improved immunosuppression with less systemic exposure and risk of side effects, and can be delivered via a dry powder inhaler to enable high local lung concentration.
Niclosamide Inhalation Powder (TFF NIC)
Niclosamide is an antiviral that recently has been shown to exhibit potent activity against SARS-CoV-2 but that has low absorption and bioavailability when administered orally. Thin Film Freezing technology produces an inhaled formulation of niclosamide that targets the lungs directly where SARS-CoV-2 infection occurs.
Niclosamide targets human cell pathways and the host’s ability to control viral replication as its mechanism of action and is therefore resistant to mutation of the SARS-CoV-2 spike protein. Development of inhaled niclosamide is part of an ongoing partnership with UNION Therapeutics.
AUG-3387 Inhalation Powder (TFF AUG-3387)
In a joint development and collaboration agreement with Augmenta Bioworks, TFF is developing an inhalable monoclonal antibody treatment against COVID-19, which has been shown to be effective against multiple variants of concern. The AUG-3387 monoclonal antibody was formulated as a dry powder using Thin Film Freezing to enable direct delivery to the lungs and remove the need for intravenous infusion, which is required for delivery of current COVID-19 antibody therapies.
Augmenta and TFF Pharmaceuticals plan to develop AUG-3387 as an inhaled therapy for the treatment of COVID-19 disease in two types of individuals: (1) those already infected with SARS-CoV-2 who are at a high risk for severe disease but who have not yet been hospitalized, and (2) for the prevention of SARS-CoV-2 infection for individuals who are at a high risk of severe disease.
Partnered Programs
Learn more about additional pipeline programs in collaboration with our biopharma, academic, government and CDMO partners.
Regulatory Pathway
We intend to use the most efficient regulatory pathway available for all of our product candidates. For our current reformulated product candidates, we intend to use the 505(b)(2) regulatory pathway, which is preferred for molecules that have been previously approved by the FDA as safe and effective and can include reformulation in a new strength or dosage form. This pathway yields significantly lower development costs and shorter development timelines versus traditional new molecular entity regulatory approaches. For products where the 505(b)(2) pathway is not applicable, Thin Film Freezing does not add any significant complexity to the regulatory pathway.