MNKD-201 for Idiopathic Pulmonary Fibrosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines a new inhalation medication, MNKD-201, to determine its safety and tolerability in individuals with Idiopathic Pulmonary Fibrosis (IPF), a lung disease that causes scarring and breathing difficulties. The study compares different doses of MNKD-201 with a placebo to understand how the body processes the drug. Individuals diagnosed with IPF who have managed their condition without recent flare-ups or infections might be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop all current medications, but you cannot use nintedanib within 30 days of screening or prednisone at doses of 10 mg/day or more within 3 months prior to screening. If you are on pirfenidone, you must be on a stable dose for at least 3 months before screening.
Is there any evidence suggesting that MNKD-201 is likely to be safe for humans?
Research has shown that MNKD-201, an inhaled version of the drug nintedanib, is safe and easy to tolerate. In one study, participants did not experience the usual side effects associated with the oral form of the drug, suggesting that MNKD-201 might cause fewer side effects when inhaled. Additionally, an early preclinical study found no harmful effects, supporting further testing. Overall, MNKD-201 appears safe for people with idiopathic pulmonary fibrosis (IPF), but more research is needed to confirm this.12345
Why do researchers think this study treatment might be promising for IPF?
MNKD-201 is unique because it delivers the active ingredient nintedanib through a dry powder inhaler, which is different from the standard oral form used in current treatments for idiopathic pulmonary fibrosis (IPF). This inhalation method may allow the drug to act directly on the lungs, potentially improving its effectiveness and reducing side effects. Researchers are excited about MNKD-201's potential to offer a more targeted approach, which could lead to better management of IPF symptoms in a shorter time frame compared to existing options.
What evidence suggests that MNKD-201 might be an effective treatment for Idiopathic Pulmonary Fibrosis?
Research has shown that nintedanib, the main ingredient in MNKD-201, may help treat idiopathic pulmonary fibrosis (IPF), a lung disease. Studies have found that nintedanib can slow the disease and extend patients' lives. This trial will test MNKD-201, delivered through inhalation, which might enhance its effectiveness by targeting the lungs directly. Participants will receive either a target dose or a high dose of MNKD-201, or a placebo. Early research on MNKD-201 indicates that it is generally well-tolerated, with manageable side effects. Although more data is needed, these findings suggest that MNKD-201 could be a promising treatment for IPF.12567
Who Is on the Research Team?
Wassim Fares, MD, MSc, FCCP
Principal Investigator
Mannkind Corporation
Are You a Good Fit for This Trial?
This trial is for people aged 40-75 with Idiopathic Pulmonary Fibrosis. They must have a certain lung function level, weigh over 88 lbs, and be able to perform required breathing tests. Women of childbearing age and men who can father children must agree to use birth control. Participants can be treatment-naive or on stable pirfenidone.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MNKD-201 or placebo via oral inhalation for 7 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MNKD-201
Trial Overview
The study is testing MNKD-201 (a form of nintedanib) against a placebo in patients with IPF. It's a Phase 1b trial focusing on how safe the drug is, how well it's tolerated, and what happens to it inside the body after inhalation compared to no active treatment.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive a high dose of MNKD-201 (Nintedanib DPI) or placebo, administered via oral inhalation twice daily for 7 days
Participants will receive a target dose of MNKD-201 (Nintedanib DPI) or placebo, administered via oral inhalation three times daily for 7 days
Participants will receive matching placebo across both cohorts of the study
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mannkind Corporation
Lead Sponsor
Michael E. Castagna
Mannkind Corporation
Chief Executive Officer since 2017
PharmD from Massachusetts College of Pharmacy & Sciences, MBA from The Wharton School of Business at the University of Pennsylvania
Burkhard Blank
Mannkind Corporation
Chief Medical Officer since 2021
MD
Citations
1.
investors.mannkindcorp.com
investors.mannkindcorp.com/news-releases/news-release-details/mannkind-successfully-completes-phase-1-trial-nintedanib-dpiMannKind Successfully Completes Phase 1 Trial of ...
MannKind Successfully Completes Phase 1 Trial of Nintedanib DPI for Pulmonary Fibrotic Diseases · These AEs were mild, transient, and fully recovered · These AEs ...
The Effectiveness of Nintedanib in Patients with Idiopathic ...
Safety and survival data in patients with idiopathic pulmonary fibrosis treated with nintedanib: Pooled data from six clinical trials.
3.
oindpnews.com
oindpnews.com/2024/11/mannkind-announces-that-results-of-phase-1-trial-of-mnkd-201-nintedanib-dpi-support-continued-development/MannKind announces that results of Phase 1 trial of MNKD ...
MannKind Corporation has announced that data from a recently completed Phase 1 study of MNKD-201 nintedanib DPI support continued development of the inhaler.
MannKind Successfully Completes Phase 1 ...
“These compelling results support advancing the development of nintedanib DPI for patients living with IPF, a chronic and progressive fibrotic ...
MNKD-201 for Idiopathic Pulmonary Fibrosis
This Phase 1 medical study run by Mannkind Corporation is evaluating whether MNKD-201 will have tolerable side effects & efficacy for ...
6.
pulmonaryfibrosisnews.com
pulmonaryfibrosisnews.com/news/mnkd-201-inhaled-nintedanib-ipf-found-safe-phase-1-trial/MNKD-201, inhaled nintedanib for IPF, found safe in Phase ...
MNKD-201 was found to be safe and well tolerated at all doses tested during the study, without causing the typical adverse events seen with the ...
Safety and Pharmacokinetic Data for Inhaled ...
Inhaled administration of nintedanib via DPI may offer advantages over oral therapies in patients with IPF, potentially reducing adverse effects ...
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