Namilumab is an investigational anti-GM-CSF monoclonal antibody for the treatment of autoimmune and inflammatory diseases administered once monthly as a subcutaneous injection
RESOLVE-Lung is a Phase 2 study evaluating the efficacy and safety of namilumab for the treatment of pulmonary sarcoidosis
Topline Phase 2 data expected in 1H 2024
NEW YORK and BASEL, Switzerland, November 17, 2022 – Kinevant Sciences, a clinical-stage biopharmaceutical company developing new medicines for rare autoimmune and inflammatory diseases, today announced that the first patient has been dosed in its RESOLVE-Lung study. This Phase 2 clinical study will evaluate the efficacy and safety of Kinevant’s namilumab for the treatment of pulmonary sarcoidosis. Namilumab is a human monoclonal antibody that targets granulocyte- macrophage colony-stimulating factor (GM-CSF), one of the key cytokines believed to be responsible for granuloma formation and persistence in sarcoidosis.
Sarcoidosis is a rare, chronic inflammatory disease that affects approximately 200,000 people in the U.S.i and more than 1 million worldwide. Sarcoidosis is characterized by granulomas, or small clusters of immune cells, that can accumulate in any organ of the body and lead to painful symptoms, organ dysfunction, and sometimes even organ failure. Approximately 90% of patients have pulmonary sarcoidosis, which can result in breathlessness, fatigue, cough and overall poor quality of life. Pulmonary sarcoidosis can also lead to pulmonary hypertension, irreversible fibrosis of the lung, and in more serious cases transplantationii.
“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,” explained Bill Gerhart, chief executive officer of Kinevant Sciences. “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. We are excited to advance namilumab as a promising new treatment for pulmonary sarcoidosis. 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.”
RESOLVE-Lung is a Phase 2 randomized, double-blind, placebo-controlled study with an open-label extension (OLE) being conducted at multiple sites in the U.S. and Europe. The study will assess the efficacy and safety of namilumab in approximately 100 patients with pulmonary sarcoidosis across a 26- week treatment period. Namilumab or placebo will be administered subcutaneously every four weeks through week 22 after the initial dosing period. All patients that complete the 26-week double-blind treatment period will be eligible to participate in a 28-week OLE treatment period on namilumab.
“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,” said Divya Patel, D.O., associate professor of medicine, sarcoid program director and interstitial lung disease program director at University of Florida. “Namilumab has the potential to address the underlying mechanisms associated with sarcoidosis. Many patients with sarcoidosis experience poor quality of life, leading to death in some cases. 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.”
Namilumab is an investigational, novel fully human monoclonal antibody conveniently administered once a month as a subcutaneous injection. Namilumab is a potent GM-CSF inhibitor that has been well-tolerated so far in more than 300 participants across multiple clinical trials.iii
The RESOLVE-Lung study is a Phase 2 clinical trial evaluating namilumab for the treatment of pulmonary sarcoidosis. Patients who qualify and agree to participate in the study will receive a once monthly injection of namilumab or placebo (following the initial dosing period) for approximately six months. This is a double-blind study, which means neither patients nor doctors and their staff will know which patients are receiving namilumab or placebo. Regardless of receiving namilumab or a placebo during the six-month double-blind treatment period, participants who complete the double-blind treatment period will be eligible to receive namilumab during a six-month OLE period. More information can be found at www.sarcoidosistrial.com.
About Kinevant Sciences
Kinevant Sciences, a subsidiary of Roivant Sciences, is a clinical-stage biopharmaceutical company developing new medicines for rare autoimmune and inflammatory diseases. The company takes a patient-first approach to drug development, advancing candidates with the potential to resolve the underlying disease and create life-changing benefit for patients. Kinevant is initially focusing on sarcoidosis with an anti-GM-CSF monoclonal antibody, namilumab, currently being evaluated in the Phase 2 RESOLVE-Lung study in patients with pulmonary sarcoidosis. Topline results are expected in the first half of 2024. For more information, visit www.kinevant.com.
About Roivant Sciences
Roivant’s mission is to improve the delivery of healthcare to patients by treating every inefficiency as an opportunity. Roivant develops transformative medicines faster by building technologies and developing talent in creative ways, leveraging the Roivant platform to launch ‘Vants’ – nimble and focused biopharmaceutical and health technology companies. For more information, please visit www.roivant.com.
i Denning DW et al. European Respiratory Journal 2013
ii Sauer WH et al. Annals ATS 2017; Baughman et al. Sarcoidosis Vasculitis and Diffuse Lung Diseases 1997
iii Taylor P et al. Arthritis Res Therapy 2019; Tanaka S et al. International J Pharmacol Therapy 2018; Papp KA et al. J Dermatol 2019; Huizinga TW et al. Arthritis Res Ther. 2017. Unpublished Ph 2 results ankylosing spondylitis