MannKind Successfully Completes Phase 1 Trial of Nintedanib DPI for Pulmonary Fibrotic Diseases

MannKind Corporation recently announced the successful completion of its first-in-human Phase 1 study of nintedanib DPI (MNKD-201) for pulmonary fibrotic diseases, including idiopathic pulmonary fibrosis (IPF).

“These compelling results support advancing the development of nintedanib DPI for patients living with IPF, a chronic and progressive fibrotic lung disease with limited treatment options,” said Michael Castagna, PharmD, Chief Executive Officer for MannKind Corporation. “We look forward to discussing the Phase 1 trial results and our proposed late-stage development program at an end of Phase 1 meeting with the FDA, planned for the first half of 2025.”

The key highlights of the study included:

• Nintedanib DPI was shown to be safe and well tolerated in healthy volunteers with the tested doses and study duration
• Participants did not experience typical adverse events seen with oral nintedanib; specifically, no GI or neurologic adverse events (AEs) were reported
• Two types of AEs noted – cough and drop in FEV-1
  -These AEs were mild, transient, and fully recovered
  -These AEs were not dose-dependent and there was no pattern of recurrence or worsening with repeated dosing
  -No bronchospasm, wheezing, other symptoms, or change in vital signs were reported
• No serious adverse events or study drug discontinuation

The completed Phase 1 was a single-site, randomized, placebo-controlled, single- (n=24) and multiple-ascending dose (n=16) study in healthy adult (older than 40 years old) participants. The primary objective of the study was to evaluate the safety and tolerability of nintedanib DPI. The secondary study objective was to evaluate the pharmacokinetics (PK) of MNKD-201.

“We are encouraged by the findings from this Phase 1 study of nintedanib DPI,” said Dr. Wassim Fares, MSc, FCCP, Senior Vice President, Therapeutic Area Head, Orphan Lung Diseases for MannKind Corporation. “Building on the known efficacy of oral nintedanib for IPF, delivery of a dry powder formulation directly to the lungs could potentially treat the disease while reducing the common adverse effects associated with oral delivery of nintedanib. Pending late-stage development trials, nintedanib DPI could offer an alternative and/or addition to current IPF therapies.”

Additionally, the preclinical chronic toxicology study did not show any adverse findings and supports further development of nintedanib DPI.

The Pulmonary Fibrosis Foundation indicates that there are over 250,000 Americans living with pulmonary fibrosis (PF) and interstitial lung disease (ILD) today, and 50,000 new cases are diagnosed each year. While the number of people affected by IPF is unknown, it is one of the most common forms of pulmonary fibrosis. IPF is predominantly identified in men but is also increasing in women.

MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life. For more information, visit mannkindcorp.com.