Our Intended Regulatory Pathway
The 505(b)(2) pathway is intended for molecules that have been previously approved by the FDA as safe and effective.
This can include reformulation of the known molecule in a new strength or dosage form. 505(b)(2) products have the advantage of potentially signiﬁcantly lower development costs and shorter development timelines versus traditional new molecular entities. We expect to utilize the 505(b)(2) pathway for all of our current product candidates.
- Inhalable Voriconazole for Invasive Pulmonary Aspergillosis
- Advantages over alternatives: Reduced side effects; direct to site
- Proof of Concept: For IPA, 3X better survival vs Amphotericin in model testing
TFF VORI is an inhaled dry powder drug intended to treat Invasive Pulmonary Aspergillosis, or IPA, a severe fungal pulmonary disease with a mortality rate that can reach 90% in some patient populations. The TFF platform can be used to generate a dry powder version of Voriconazole, generally considered to be the best antifungal drug used in the treatment of IPA.
A TFF prepared dry powder formulation of Voriconazole administered directly to the lungs maximizes both the prophylactic value for patients susceptible to IPA and the treatment value of patients suffering from chronic IPA. TFF Vori beneﬁts patients by providing the drug at the “port of entry” of invasive fungal infections, while also reducing or eliminating the unpleasant and potentially devastating side effects associated with Voriconazole and other last line antifungals.
TFF TAC-LAC 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 for patients and physicians when used for extended periods. Tacrolimus can cause toxicity in the kidneys, particularly when used in high doses. TFF TAC-LAC is a dry powder version suitable for use with a dry powder inhaler. This provides for a high local lung concentration without the problems of an orally dosed tacrolimus.
- Inhalable Tacrolimus for Prevention of Rejection of Organ Transplant
- Advantages over alternatives: Reduced side effects; direct to site delivery
- Effective in model study of lung transplant
TFF Triple Combination For COPD/Asthma
TFF Triple Combination For COPD/Asthma is an inhaled dry powder drug combination intended to treat chronic obstructive pulmonary disease, or COPD, and asthma. There is a trend towards the use of a three-drug combination in the treatment of uncontrolled COPD and asthma. A variety of triple combinations are currently approved for marketing or are under development by large pharmaceutical companies.
We are currently pursuing the development of combination dry powder drugs intended for use with a dry powder inhaler containing budesonide, formoterol fumarate and tiotropium bromide for the maintenance treatment of bronchospasm associated with moderate to severe COPD. Unlike most other triple combinations, which are chosen in part from the pharmaceutical company’s list of existing products, our triple combination drug contains what we consider to be the best-in-class drug in each category. Since competition exists, and typically large clinical trials are needed to approve this type of triple combination drug, we expect to develop the triple combination dry powder drug in partnership with a large pharmaceutical company looking to compete in the COPD and asthma markets.