The biopharma TFF Pharmaceuticals (NSDQ:TFFP) has announced that its inhalation powder of the immunosuppressive drug tacrolimus was well tolerated in a Phase 1 trial in lung transplant patients.
Tacrolimus is a traditional option for preventing rejection of a transplanted organ, albeit in tablet or capsule form.
It is common for lung transplant recipients to have high tacrolimus blood concentrations. Such concentrations are linked to an elevated risk of acute kidney injury and, potentially, chronic kidney disease. To minimize the risk of injury, physicians rely on therapeutic drug monitoring to maintain consistent drug levels in a narrow window.
TFF Pharmaceuticals believes that inhalable tacrolimus can potentially address the problem by maintaining high levels of the drug at the graft site rather than systemically.
TFF plans to conduct a Phase 2 study of the powdered tacrolimus in lung transplant recipients.
“The data from this Phase 1 study suggests that tacrolimus inhalation powder can be administered with an acceptable safety profile to achieve the appropriate balance of local and systemic concentrations for immunosuppression at the site of the lung transplant while minimizing the risk of supra-therapeutic systemic exposure well known to cause substantial renal toxicity in these patients,” said Glenn Mattes, CEO of TFF Pharmaceuticals, in a statement. “We believe the strong dose-dependent PK data with pulmonary administration will allow a flexible dosing regimen that can be tailored to each patient, consistent with the manner in which these patients are managed in the real-world setting. This flexible dosing approach will also be reflected in the design for our upcoming Phase 2 study in lung transplant recipients.”