Inhaled IPF therapy moves to Phase 2 as early trial shows promise
Mannkind enrolling patients at sites worldwide to further test safety
Written by |
The inhaled therapy MNKD-201 was tolerated well in people with idiopathic pulmonary fibrosis (IPF) in a Phase 1 clinical trial, and a Phase 2 study to further test it is underway, the treatment’s developer said.
The Phase 2 trial, INFLO-2 (NCT07679893), aims to enroll more than 200 adults with IPF, ages 40 to 80, who are either new to treatment or are on a stable dose of Esbriet (pirfenidone) and/or Jascayd (nerandomilast). Participants will be randomly assigned to take one of two dose regimens of MNKD-201 — 2 mg four times daily or 4 mg twice daily — or a placebo for about three months, after which all will receive MNKD-201 for another six months, according to a press release from developer Mannkind.
The main goal is to further evaluate the safety and tolerability of MNKD-201, though researchers will also look at how the therapy affects standard measures of lung function. The study is planned to run at more than 80 sites worldwide, and one site in Canada is currently recruiting participants.
IPF is a chronic disorder marked by fibrosis, or scarring, in the lungs. MNKD-201 is a formulation of nintedanib, the active ingredient in Ofev, a widely approved IPF treatment sold by Boehringer Ingelheim. Ofev is given as oral capsules, and has been proven in clinical trials to slow lung function decline in people with IPF. However, the oral therapy can cause digestive side effects like nausea and diarrhea, which can make it hard for some patients to take it long-term.
MNKD-201 is a dry powder inhalation formulation of nintedanib, designed to deliver the drug directly to the lungs to preserve therapeutic effectiveness while minimizing side effects elsewhere in the body.
Early studies promising
Mannkind sponsored a Phase 1b study, INFLO-1 (NCT07344558), to assess the safety and tolerability of MNKD-201. That study enrolled 27 people with IPF, and participants were randomly assigned to a week of treatment with MNKD-201 or a placebo.
According to the company, safety data from the Phase 1b study were positive: No serious safety issues were reported, and none of the participants discontinued or required a dose reduction due to safety concerns. There were no reported digestive side effects and no events of bronchospasm (a condition in which the lung muscles tighten, causing difficulty breathing). Slightly less than half of the participants experienced coughing as a side effect, usually mild.
Overall, the data are consistent with findings from a Phase 1a trial that tested MNKD-201 in healthy volunteers, the company noted.
“Across our Phase 1a and Phase 1b studies, participants have received more than 700 inhalations of [MNKD-201], including nearly 450 inhalations administered to people living with IPF,” said Michael Castagna, Mannkind’s CEO. “Importantly, cough was not a meaningful barrier to treatment. When observed, cough events were generally mild, transient and resolved, with no cough-related discontinuations or dose reductions. These findings provide growing confidence as we continue to advance Phase 2 development.”
Leave a comment
Fill in the required fields to post. Your email address will not be published.