Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

TFF Pharmaceuticals sees promise in Phase 1 trial of inhaled tacrolimus powder for lung transplant

By Brian Buntz | September 23, 2021

TFFThe 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.”


Filed Under: Immunology, Pulmonology, Uncategorized
Tagged With: acute kidney injury, lung transplant, tacrolimus, TFF Pharmaceuticals
 

Tell Us What You Think! Cancel reply

You must be logged in to post a comment.

Related Articles Read More >

lab microscope
Accelerating R&D with FAIR data
Amylyx
Amylyx notches first global approval for oral ALS therapy Albrioza
Novavax
FDA advisory panel backs Novavax COVID-19
Sage and Biogen
Zuranolone could offer rapid relief from postpartum depression 

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Medtech100 Index
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50