Canvas Pharmaceuticals is developing a patented tacrolimus inhalation powder delivered via a dry‑powder inhaler to provide localized immunosuppression for lung transplant patients. The direct‑to‑lung delivery achieves therapeutic drug levels in the transplanted lung while minimizing systemic exposure, reducing renal toxicity and improving graft outcomes. Early-phase data show prevention of acute rejection and preservation of renal function, supporting its potential as a safer alternative to oral tacrolimus.
Funding
Funding not disclosed
Founders
Product
Problem
Oral tacrolimus, the standard immunosuppressant for lung transplant recipients, is associated with systemic toxicities—particularly renal impairment—and requires high systemic exposure to prevent acute rejection. These side effects limit dosing flexibility and can compromise long‑term graft survival.
Solution
Canvas Pharmaceuticals is developing a patented Tacrolimus Inhalation Powder (TIP) delivered via a dry‑powder inhaler to provide localized immunosuppression directly to the transplanted lung. By targeting the allograft, TIP achieves therapeutic concentrations in the lung while minimizing systemic exposure, thereby reducing renal toxicity. Early-phase clinical data in 14 patients demonstrated prevention of acute rejection, suppression of rejection‑related gene expression, avoidance of donor‑specific antibodies, and preservation of renal function. The formulation leverages thin‑film freezing technology to produce a high‑potency, low‑excipient dry powder with favorable aerosol performance. An upcoming randomized Phase 2 trial will compare TIP directly against oral tacrolimus, and the product has received orphan‑drug designation.
Target Audience
Primary customers are lung transplant programs, transplant surgeons, and pulmonologists seeking safer, more effective immunosuppression for post‑transplant patients, as well as pharmaceutical partners interested in out‑licensing inhaled immunosuppressant or antifungal products.
Features
- Patented dry‑powder formulation of tacrolimus optimized by thin‑film freezing for high lung deposition
- Easy‑to‑use single‑dose dry‑powder inhaler enabling patient‑self administration
- Direct‑to‑lung delivery yields high local drug concentrations with reduced systemic exposure
- Improved pharmacokinetic profile demonstrated in phase 2 open‑label study (maintained renal function, prevented acute rejection)
- Orphan‑drug designation supporting regulatory incentives
- Planned comparator‑controlled Phase 2 trial to establish efficacy versus oral tacrolimus
- Parallel pipeline includes Voriconazole Inhalation Powder for pulmonary fungal infections