DPI developer TFF Pharmaceuticals said that the FDA has granted orphan drug designation to its dry powder tacrolimus for the prevention of lung transplant rejection. The company also said that it plans to initiate a Phase 1 SAD study of the tracrolimus inhalation powder this month followed by a MAD study in the third quarter of this year.
TFF President and CEO Glenn Mattes commented, “The FDA’s orphan drug designation is an important milestone in our development plan for tacrolimus inhalation powder for the prevention of rejection of solid organ transplants. We believe that our dry powder version of tacrolimus can provide for greater local lung concentrations that provide enhanced lung transplant rejection without the typical systemic toxicity frequently experienced with oral dosage form immunosuppressants, and be an important treatment option for lung transplant patients.”
In November 2019, TFF announced the initiation of a Phase 1 trial of its dry powder voriconazole, which is in development for the treatment of invasive pulmonary aspergillosis. Earlier this year, TFF announced that it was working on a universal influenza vaccine in partnership with the Universities of Georgia and Texas and that it would also develop dry powder vaccines in partnership with the US Army.
Read the TFF Pharmaceuticals press release.
