First Patient Dosed in Phase 2 Trial of Namilumab
Participants sought to test the experimental treatment for pulmonary sarcoidosis
The first participant has been dosed in a Phase 2 clinical trial testing the experimental therapy namilumab in people with pulmonary sarcoidosis, the therapy’s developer Kinevant Sciences announced.
“We are excited to advance namilumab as a promising new treatment for pulmonary sarcoidosis since it has a mechanism of action that we believe targets the underlying sarcoidosis disease pathology and an established safety and tolerability profile, having been previously evaluated in more than 300 trial participants,” Bill Gerhart, Kinevant’s CEO, said in a press release.
The study, called RESOLVE-Lung (NCT05314517), intends to enroll approximately 100 adults with pulmonary sarcoidosis at multiple sites in the U.S. and Europe. Patients must be vaccinated for COVID-19 to be eligible for the study. Participants are being recruited at over a dozen locations in the U.S., and more information about participation is available on the trial’s website.
Participants in RESOLVE-Lung will be assigned randomly to receive either namilumab or a placebo, administered via subcutaneous (under-the-skin) injection once monthly for about six months. The main goal is to assess the effect of treatment on forced vital capacity, a measure of lung function based on how much a person can forcibly exhale.
After the placebo-controlled part of the study, participants will have the option to continue into an open-label extension where all will be treated with namilumab for 28 weeks (a little more than half a year).
Sarcoidosis is caused by the formation of clumps of immune cells called granulomas. Namilumab is a monoclonal antibody that is designed to block a signaling molecule that drives granuloma formation and persistence called GM-CSF (granulocyte-macrophage colony-stimulating factor).
“Namilumab has the potential to address the underlying mechanisms associated with sarcoidosis,” said Divya Patel, DO, associate professor of medicine, sarcoid program director and interstitial lung disease program director at the University of Florida in Gainesville.
Fewer pulmonary sarcoidosis treatment side effects
According to Gerhart, this mechanism of action may allow namilumab to address pulmonary sarcoidosis more effectively and with fewer side effects than other available treatments.
“Pulmonary sarcoidosis patients are frequently treated with oral corticosteroids, yet only half will experience symptom resolution after one or two courses, leaving those who do not respond with no other option than to continue on oral steroids or try other immunosuppressive therapies off-label,” Gerhart said. “Steroids for long-term disease management can be challenging for patients because of significant negative side effects, and other immunosuppressive therapies are often not effective and/or poorly tolerated.”
Added Patel: “Rare inflammatory diseases, including sarcoidosis, are complex disorders that are challenging to diagnose and difficult to treat as there are limited, often ineffective treatment options. … Halting granuloma formation and associated inflammation has greater potential to prevent organ dysfunction and failure, while also maintaining a better quality of life, than is possible with current treatment options.”