Namilumab Discontinued After Phase II Trial Failure for Pulmonary Sarcoidosis

Kinevant Sciences, a unit in Roivant, announced that its Phase II RESOLVE-Lung study of namilumab, an investigational treatment for chronic active pulmonary sarcoidosis, did not meet its primary or secondary endpoints. Consequently, the company has decided to discontinue the development of the drug for this condition.

This setback comes amid progress in Roivant’s broader clinical pipeline. Brepocitinib has sustained efficacy in the Phase II NEPTUNE study for non-infectious uveitis, now progressing to Phase III trials. Batoclimab has shown promising proof-of-concept results in Graves’ disease, achieving rapid and meaningful immunoglobulin G (IgG) reduction. Meanwhile, mosliciguat, a once-daily inhaled soluble guanylate cyclase (sGC) activator, has entered Phase II trials for pulmonary hypertension associated with interstitial lung disease, supported by Phase Ib data showing one of the highest reductions in pulmonary vascular resistance recorded for the condition.

Namilumab, a monoclonal antibody targeting granulocyte macrophage colony-stimulating factor (GM-CSF), was investigated for its potential to reduce lung inflammation and granuloma formation in sarcoidosis. GM-CSF, a pro-inflammatory cytokine, is thought to recruit immune cells that contribute to lung damage. The drug was administered as a monthly subcutaneous injection.

The RESOLVE-Lung study enrolled 107 patients with chronic active pulmonary sarcoidosis across the US and Europe. Participants received either namilumab or a placebo over a six-month double-blind period, followed by an optional open-label extension.

The primary endpoint evaluated the proportion of patients experiencing a “rescue event,” defined as disease worsening requiring intervention. Secondary endpoints assessed lung function, corticosteroid tapering and quality of life (QoL).

Results showed no significant differences between namilumab and placebo in reducing rescue events or improving lung function. Measures like forced vital capacity, steroid reduction and patient-reported outcomes also failed to show a clear benefit, though the drug’s safety profile remained consistent with previous studies.

Chronic active pulmonary sarcoidosis is a challenging condition, marked by granulomas in lung tissue that cause inflammation, scarring and, in severe cases, lung failure. Current treatments, including corticosteroids and immunosuppressants, often fall short, leaving many of the 200,000 US patients and over a million globally with an urgent need for safer, more effective therapies.

Beyond sarcoidosis, Roivant’s strategic achievements highlight its resilience. The company recently closed a transaction with Organon for Dermavant, securing $184 million in cash and reducing long-term debt. Regulatory progress also continues, with Vtama (tapinarof) in atopic dermatitis targeting approval in early 2025. Roivant has repurchased $754 million in shares through September 2024, underscoring financial stability.

Despite the RESOLVE-Lung results, Kinevant plans to publish trial data to guide future research.

Pulmonary conditions remain an area of immense unmet need, where scientific exploration often brings both breakthroughs and setbacks.

This year reflects that reality — while the RESOLVE-Lung study of namilumab fell short, the US Food and Drug Administration’s (FDA’s) Breakthrough Therapy designation for sacituzumab tirumotecan (sac-TMT) in advanced non-small cell lung cancer (NSCLC) offers hope for innovative treatments. On the other hand, Roche’s Phase III SKYSCRAPER-01 trial for advanced lung cancer did not meet its primary endpoint, underscoring the challenges of tackling complex pulmonary diseases.

These moments serve as reminders that persistence drives progress, paving the way for transformative therapies that patients desperately need.