We understand that living with sarcoidosis can be challenging, and many of you are constantly seeking new treatment options. We want to share an important update regarding recently announced results from a pulmonary sarcoidosis clinical trial.
Key Points:
- Trial Results: Topline results of the Kinevant Phase 2 RESOLVE-Lung study demonstrate that namilumab does not provide a treatment benefit for patients with chronic active pulmonary sarcoidosis.
- Next Steps: With these results, Kinevant will be discontinuing further development of namilumab for the treatment of sarcoidosis. Kinevant is committed to publishing the results of RESOLVE-Lung to inform future sarcoidosis research.
“Although RESOLVE-Lung failed to show a treatment benefit for namilumab, the significant amount of information produced by the study will be tremendously helpful to those in the field who are committed to improving the lives of sarcoidosis patients,” said Bill Gerhart, CEO of Kinevant. “I would like to thank all the patients who courageously volunteered to participate in the study, as well as the Kinevant team, industry partners, principal investigators, site staff, and patient advocacy groups who all worked together to successfully conduct this important study for sarcoidosis.”
We are grateful to Kinevant Sciences for their dedication to developing new medicines for rare inflammatory and autoimmune diseases.
What Sarcoidosis Patients Should Know:
- Clinical Trial Success Rates: Despite the best efforts of drug developers, clinicians, patients and trial participants, patient advocacy organizations, and others, the overall average success rate of clinical trials is only 8%[i], and 14% for rare diseases specifically (excluding cancer trials)[ii].
- Ongoing Research: While this study did not yield positive results, it’s important to remember that medical research is a continuous process. Each study, even those with disappointing outcomes, contributes valuable information to the field.
- Hope for the Future: Researchers and pharmaceutical companies continue to investigate new potential treatments for sarcoidosis. This setback does not diminish the ongoing efforts to find better solutions for patients.
Moving Forward:
- FSR’s Progress: FSR is making progress in ensuring the patient voice and preferences for treatments are considered by both the FDA and drug developers. FSR’s Coalition for Clinical Trial Equity is also well-positioned towards reducing barriers and making clinical trials more accessible. This work is a reflection of the incredible investment of the larger sarcoidosis community to continue to share their stories and push for solutions.
- Watch the Externally Led Patient-Focused Drug Development meeting on sarcoidosis hosted by FSR on October 28, 2024: https://www.stopsarcoidosis.org/pfdd/
- Ready about the latest success in reducing barriers to clinical trial participation: https://www.stopsarcoidosis.org/fsr-receives-confirmation-from-the-department-of-labor-ensuring-patient-access-to-fmla-for-participation-in-clinical-trials/
- Participate in Research: Consider participating in future clinical trials if you’re eligible. Your involvement can help advance sarcoidosis research. Participate in the FSR Patient Registry or sign up for FSR’s clinical trial notification listserv.
- Support and Resources: Remember that you are not alone. Reach out to sarcoidosis support groups and patient advocacy organizations for additional information and community support.
“We extend our deepest gratitude to the individuals with sarcoidosis who courageously participated in the RESOLVE-Lung study,” said Mary McGowan, CEO of FSR. “While these results may not have met our hopes, they underscore the challenges of advancing rare disease research and the importance of persistence. Each study brings us closer to understanding this complex disease and finding better treatment options. FSR remains steadfast in our commitment to supporting patients, fostering research, and advocating for breakthroughs that will improve the lives of those living with sarcoidosis.”
We are so grateful to the individuals with sarcoidosis who participated in the RESOLVE-Lung study! While the results of this study may be disappointing, they represent just one step in the ongoing journey to improve sarcoidosis treatment. The community remains committed to finding better solutions for those living with sarcoidosis.
[i]https://pmc.ncbi.nlm.nih.gov/articles/PMC10173933/#:~:text=Clinical%20trials%20are%20an%20essential,high%20risk%20for%20biopharmaceutical%20companies.
[ii] https://academic.oup.com/biostatistics/article/20/2/273/4817524?login=false