Kinevant Sciences has announced the dosing of the first patient in its Phase II RESOLVE-Lung clinical trial of namilumab to treat pulmonary sarcoidosis, a rare, chronic inflammatory disease.
The trial will evaluate the efficacy and safety of an investigational, new, fully human monoclonal antibody namilumab that acts on granulocyte- macrophage colony-stimulating factor (GM-CSF).
The Phase II double-blind, randomised, placebo-controlled trial has an open-label extension (OLE) and is being carried out at multiple US and European sites.
It will evaluate the antibody in nearly 100 patients with pulmonary sarcoidosis across a treatment period of 26 weeks.
Trial participants will receive namilumab or a placebo subcutaneously every four weeks till week 22 following the initial dosing period.
All who complete this double-blind treatment period can take part in a 28-week OLE treatment period on namilumab, regardless of receiving the antibody or a placebo during this period.
Kinevant Sciences CEO Bill Gerhart said: “Pulmonary sarcoidosis symptoms often resolve after one or two courses of oral corticosteroids, but in about half of all patients the disease persists, requiring patients to maintain oral steroids or try other immunosuppressive therapies off label.
“Chronic use of steroids for long-term disease management often leads to significant side effects, and other immunosuppressive therapies are often ineffective and/or poorly tolerated.
“Namilumab has an established safety and tolerability profile from more than 300 previous trial participants and a mechanism of action that we believe targets the underlying disease pathology of sarcoidosis.”
The potent GM-CSF inhibitor monoclonal antibody is administered once a month as a subcutaneous injection for nearly six months.