Pipeline
In an open label, single arm, Phase 2 study of 14 lung transplant patients, Tacrolimus Inhalation Powder prevented acute rejection, decreased the expression of rejection related gene sets, prevented formation of donor-specific antibodies, and maintained renal function.
A randomized, comparator-controlled Phase 2 study evaluating Tacrolimus Inhalation Powder versus oral tacrolimus is planned.
Canvas plans to out-license/partner Voriconazole Inhalation Powder for prevention and/or treatment of pulmonary fungal infections.
Publications
Selected clinical publications
Multicenter Open-Label Trial Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics (PK) of Tacrolimus Inhalational Powder as a Replacement to Oral Tacrolimus (TAC) in Lung Transplant (LTx) Recipients with Renal Insufficiency. Snell G, Thomson C, Levvey B, Katoni K, Ndweni N, Stewart L, Singleton L and Mikhak Z. Journal of Heart and Lung Transplantation. 2025; 44(4): S71. 
Multicenter open-label Tacrolimus Inhalation Powder trial evaluating safety, tolerability, efficacy and pharmacokinetics (pk) in lung transplant (ltx) recipients with significant renal impairment. Snell G, Levvey B, Westall G, Christensen D, Hudson C and Mikhak Z. Journal of Heart and Lung Transplantation. 2024; 43(4): S309.
Inhaled immunosuppressants after lung transplantation –real potential to enhance patient outcomes. Snell G, Ennis S, Levvey B. Expert Review of Respiratory Medicine. 2024; 18(12): 925-927.
Voriconazole inhalation powder: A novel therapeutic alternative for invasive pulmonary fungal infections.Gardiner BJ, Ivulich SP, Snell GI. Transplant Infectious Disease. 2024; 26(3):e14264.
A Safety and Tolerability Study of Thin-film Freeze-dried Tacrolimus for Local Pulmonary Drug Delivery in Human Subjects. Sahakijjpijarn S, Beg M, Levine SM, Peters JI and Williams III RO. Pharmaceutics. 2021; 13,717.
Safety and Tolerability of Single Dose Inhaled Dry Powder Tacrolimus in Healthy Subjects. Levine S, Singh H, Williams R, Watts A, Anzueto A, Talbert R, Peters J. Chest. 2013;144 (4):1011A.
Safety and Tolerability of Single Dose Inhaled Tacrolimus in Healthy Subjects. Levine S; Singh H, Williams R, O’Donnell K, Lang B, Wang Y, Anzueto A, Talbert R, Peters J.Chest. 2011;140 (4):1020A.
Selected pre-clinical publications
Evaluating Drug Distribution in Rat Lung by Mass Spectrometry Imaging after Dry Powder Insufflation: Comparison of Jet-milling, Spray-drying, and Thin-Film Freezing. Moon C, Maier EY, Seeley EH, Warnken ZN, Behrend-Keim B, Yanwinitchai S, Moto M and Williams III RO. Journal of Drug Delivery Science and Technology. 2024; 101:106206.
Using Thin Film Freezing to Minimize Excipients in Inhalable Tacrolimus Dry Powder Formulations. Sahakijpijarn S, Moon C, Ma X, Su Y, Koleng JJ, Dolocan A and Williams III RO. International Journal of Pharmaceutics. 2020; 586:119490.
Enhanced Aerosolization of High Potency Nanoaggregates of Voriconazole by Dry Powder Inhalation. Moon C, Watts AB, Lu X, Su Y, and Williams, III RO. Molecular Pharmaceutics. 2019; 16, 5:1799-1812.
Processing design space is critical for voriconazole nanoaggregates for dry powder inhalation produced by thin film freezing. Moon C, Sahakijpijarn S, Koleng JJ, Williams III RO. Journal of Drug Delivery Science and Technology. 2019; 54:101295.
In Vitro and In Vivo Performance of Dry Powder Inhalation Formulations: Comparison of Particles Prepared by Thin Film Freezing and Micronization. Wang YB, Watts AB, Peters JI, Liu S, Batra A and Williams III RO. AAPS PharmSciTech. 2014; 15 (4):981-993.
Dry Powder Insufflation of Crystalline and Amorphous Voriconazole Formulations Produced by Thin Film Freezing to Mice. Beinborn NA, Du J, Widerhold NP, Smyth HDC and Williams III RO. European Journal of Pharmaceutics and Biopharmaceutics. 2012; 81:600-608.
Effect of Process Variables on Morphology and Aerodynamic Properties of Voriconazole Formulations Produced by Thin Film Freezing. Beinborn NA, Lirola HL and Williams III RO. International Journal of Pharmaceutics. 2012; 429:46-57.
Preclinical Evaluation of Inhaled Tacrolimus Colloidal Dispersion for Inhalation. Watts AB, Peters JI, Talbert RL, O’Donnell KP, Coalson JJ and Williams III RO. European Journal of Pharmaceutics and Biopharmaceutics. 2011; 77:207-215.
Characterization and Pharmacokinetic Analysis of Tacrolimus Dispersion for Nebulization in a Lung Transplanted Rodent Model. Watts AB, Cline AM, Saad AR, Hsiung G, Johnson SB, Peters JI and Williams III RO. International Journal of Pharmaceutics. 2010; 385:46-52.
Mechanisms behind Local Immunosuppression Using Inhaled Tacrolimus in Preclinical Models of Lung Transplantation. Deuse T, Blankenberg F, Haddad M, Reichenspurner H, Phillips N, Robbins R and Shcrepfer S. American Journal of Respiratory Cell and Molecular Biology. 2010; 43: 403–412.
Nebulization of Nanoparticulate Amorphous or Crystalline Tacrolimus – Single Dose Pharmacokinetic Study in Mice. Sinswat P, Overhoff KA, McConville JT, Johnston KP and Williams III RO. European Journal of Pharmaceutics and Biopharmaceutics. 2008; 69:1057-1066.
Effect of Stabilizer on the Maximum Degree and Extent of Supersaturation and Oral Absorption of Tacrolimus Made By Ultra-Rapid Freezing. Overhoff KA, McConville JT, Yang W, Johnston KP and Williams III RO. Pharmaceutical Research. 2008; 25:167-175.
Effect of Inhaled Tacrolimus on Cellular and Humoral Rejection to Prevent Posttransplant Obliterative Airway Disease. Schrepfer S, Deuse T, Reichenspurner H, Hoffmann J, Haddad M, Fink J, Fischbein M, Robbins R, and Pelletier M. American Journal of Transplantation. 2007;7:1733-1742.
