Kinevant Sciences Announces Topline Results from Phase 2 RESOLVE-Lung Study of Namilumab in Chronic Active Pulmonary Sarcoidosis
Kinevant Sciences announced that its Phase 2 RESOLVE-Lung study of namilumab failed to demonstrate treatment benefits in patients with chronic active pulmonary sarcoidosis. The study evaluated the efficacy and safety of namilumab, an investigational anti-GM-CSF monoclonal antibody administered monthly via subcutaneous injection. The treatment failed to meet both its primary endpoint regarding Rescue Events and secondary endpoints, including changes in forced vital capacity, corticosteroid tapering success, and patient-reported outcomes. Following these results, Kinevant will discontinue further development of namilumab for sarcoidosis treatment but commits to publishing the study results to support future research.
Kinevant Sciences ha annunciato che il suo studio di Fase 2 RESOLVE-Lung su namilumab non ha dimostrato benefici terapeutici in pazienti con sarcoidosi polmonare cronica attiva. Lo studio ha valutato l'efficacia e la sicurezza di namilumab, un anticorpo monoclonale anti-GM-CSF in fase di sperimentazione, somministrato mensilmente tramite iniezione sottocutanea. Il trattamento non ha raggiunto né l'obiettivo primario riguardante gli eventi di salvataggio né gli obiettivi secondari, inclusi i cambiamenti nella capacità vitale forzata, il successo nel ridurre i corticosteroidi e gli esiti riferiti dai pazienti. A seguito di questi risultati, Kinevant interromperà ulteriore sviluppo di namilumab per il trattamento della sarcoidosi, ma si impegna a pubblicare i risultati dello studio per supportare future ricerche.
Kinevant Sciences anunció que su estudio de Fase 2 RESOLVE-Lung sobre namilumab no demostró beneficios en el tratamiento de pacientes con sarcoidosis pulmonar activa crónica. El estudio evaluó la eficacia y seguridad de namilumab, un anticuerpo monoclonal anti-GM-CSF en investigación, administrado mensualmente mediante inyección subcutánea. El tratamiento no logró cumplir con su objetivo primario relacionado con los Eventos de Rescate ni con los objetivos secundarios, incluidos los cambios en la capacidad vital forzada, el éxito en la disminución de corticosteroides y los resultados reportados por los pacientes. Tras estos resultados, Kinevant discontinuará el desarrollo de namilumab para el tratamiento de la sarcoidosis, pero se compromete a publicar los resultados del estudio para apoyar futuras investigaciones.
키네반트 사이언스(Kinevant Sciences)는 나밀루맙(namilumab)에 대한 2상 RESOLVE-Lung 연구가 만성 활성 폐사르코이드증 환자에서 치료 효과를 입증하지 못했다고 발표했습니다. 이 연구는 월 1회 피하 주사를 통해 투여되는 실험적인 항-GM-CSF 단클론 항체인 나밀루맙의 효능과 안전성을 평가했습니다. 치료는 구조적 사건에 대한 주된 목표 및 강제 폐활량 변화, 코르티코스테로이드 감소 성공 및 환자가 보고한 결과와 같은 보조 목표를 모두 충족하지 못했습니다. 이러한 결과에 따라 키네반트는 사르코이드증 치료를 위한 나밀루맙의 추가 개발을 중단하겠지만, 향후 연구 지원을 위해 연구 결과를 발표할 것을 약속합니다.
Kinevant Sciences a annoncé que son étude de Phase 2 RESOLVE-Lung sur namilumab n'a pas démontré de bénéfices thérapeutiques chez des patients atteints de sarcoïdose pulmonaire active chronique. L'étude a évalué l'efficacité et la sécurité de namilumab, un anticorps monoclonal anti-GM-CSF en cours de recherche, administré mensuellement par injection sous-cutanée. Le traitement n'a pas réussi à atteindre son principal objectif lié aux Événements de Sauvetage ni les objectifs secondaires, y compris les changements de capacité vitale forcée, le succès de la réduction des corticostéroïdes et les résultats rapportés par les patients. Suite à ces résultats, Kinevant cessera le développement de namilumab pour le traitement de la sarcoïdose, mais s'engage à publier les résultats de l'étude pour soutenir les recherches futures.
Kinevant Sciences hat angekündigt, dass die Phase-2-Studie RESOLVE-Lung zu namilumab bei Patienten mit chronischer aktiver pulmonaler Sarkoidose keine therapeutischen Vorteile zeigen konnte. Die Studie bewertete die Wirksamkeit und Sicherheit von namilumab, einem experimentellen anti-GM-CSF-Monoklonalen Antikörper, der monatlich subkutan injiziert wurde. Die Behandlung erreichte weder ihr primäres Ziel hinsichtlich der Rettungsereignisse noch die sekundären Endpunkte, einschließlich Veränderungen der forcierten Vitalkapazität, des Erfolgs bei der Reduzierung von Kortikosteroiden und der von Patienten berichteten Ergebnisse. Nach diesen Ergebnissen wird Kinevant die weitere Entwicklung von namilumab zur Behandlung der Sarkoidose einstellen, verpflichtet sich jedoch, die Studienergebnisse zu veröffentlichen, um zukünftige Forschungen zu unterstützen.
- Safety profile remains consistent with previous studies
- Failed to meet primary endpoint in Phase 2 RESOLVE-Lung study
- Failed to achieve secondary efficacy endpoints
- Development of namilumab for sarcoidosis treatment discontinued
- Investment in drug development resulted in failure
Insights
The Phase 2 RESOLVE-Lung study failure represents a significant setback for Kinevant Sciences and parent company Roivant. The trial's comprehensive failure across both primary and secondary endpoints is particularly concerning, as namilumab showed no meaningful treatment benefit for pulmonary sarcoidosis patients. The decision to discontinue further development eliminates a potential revenue stream and impacts Roivant's pipeline diversity.
The complete absence of efficacy signals, despite meeting safety parameters, suggests fundamental issues with the drug's mechanism of targeting GM-CSF for sarcoidosis treatment. While the safety profile remains consistent with previous studies, the lack of therapeutic benefit across multiple measured outcomes indicates minimal salvage value for this indication. This outcome affects Roivant's near-term growth prospects in the rare disease space and may influence investor confidence in the company's development strategy for similar immunological programs.
- Namilumab failed to show treatment benefit in patients with pulmonary sarcoidosis
- Further development of namilumab for the treatment of sarcoidosis will be discontinued
BASEL, Switzerland and LONDON and NEW YORK, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Kinevant Sciences, a clinical-stage biopharmaceutical company developing new medicines for rare inflammatory and autoimmune diseases, today announced its Phase 2 study failed to show treatment benefit in patients with chronic active pulmonary sarcoidosis. The Phase 2 RESOLVE-Lung study (NCT05314517) evaluated the efficacy and safety of namilumab, an investigational anti-GM-CSF monoclonal antibody administered once-monthly as a subcutaneous injection, in participants with chronic active pulmonary sarcoidosis.
Primary Endpoint Details: Namilumab failed to meet the primary endpoint of proportion of subjects with a Rescue Event during the double-blind period.
Secondary Endpoints Details: Secondary efficacy endpoints, including change in percent predicted forced vital capacity, corticosteroid tapering success, and change in the patient reported King’s Sarcoidosis Questionnaire failed to show a treatment benefit consistent with the primary endpoint.
Safety Details: The safety profile of namilumab in RESOLVE-Lung remains similar to previous studies.
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.”
“Risk-taking in clinical development is at the heart of our industry, and core to Roivant’s mission of developing new medicines for patients in need. It’s evident from our data that the RESOLVE-Lung study was thoughtfully designed and gave us a clear read on the potential benefits of namilumab in this patient population,” said Matt Gline, CEO of Roivant. “Unfortunately science is sometimes humbling, and we are proud to have made the attempt, as well as of our successes in other programs this year. We look forward to taking calculated risks on similar programs in the future.”
About RESOLVE-Lung
The RESOLVE-Lung study is a Phase 2 randomized, double-blind, placebo-controlled study of namilumab for the treatment of pulmonary sarcoidosis at sites in the U.S. and Europe. The study enrolled 107 patients with pulmonary sarcoidosis considered to have chronic, active disease not well-controlled despite available therapeutic options. Patients in the study received a once-monthly subcutaneous injection of namilumab or placebo (following the initial dosing period) for approximately six months. All patients who complete the 26-week double-blind treatment period were eligible to participate in a 28-week open-label extension treatment period on namilumab.
The primary endpoint of this study was proportion of subjects with a Rescue Event during the double-blind period. Rescue Event was defined as clinically significant worsening of a subject’s sarcoidosis requiring treatment, failure to adhere to the protocol defined OCS taper, or premature discontinuation from the study associated with lack of benefit during the double-blind treatment period.
Study eligibility did not require subjects to be on high dose corticosteroids. If subjects were on >5mg/day of oral corticosteroid (OCS) at baseline, they were required to taper down to 5mg/day 8-10 weeks after randomization. If patients were on an immunosuppressive therapy (IST), they were required to stop the IST at randomization. Notably, all subjects enrolled had evidence of active pulmonary sarcoidosis disease, defined as a positive HRCT scan, significant lung inflammation on PET, and moderate to severe self-reported breathlessness.
About Sarcoidosis
Pulmonary sarcoidosis is a lung disease characterized by the presence of granulomas (clumps of immune cells) of unknown etiology that can cause breathlessness, fatigue, and pain. The resulting inflammation, if not effectively treated, can result in lung tissue scarring (fibrosis), lung dysfunction, and eventually lung failure. Approximately
Approximately 200,000 people in the U.S. (and more than 1 million worldwide) are estimated to have sarcoidosis, an immune-mediated inflammatory disease that can affect any organ in the body, with about
About Namilumab
Granulocyte macrophage colony stimulating factor (GM-CSF) is a pro-inflammatory cytokine over-expressed in several inflammatory diseases, including sarcoidosis. GM-CSF mediated pro-inflammatory signaling is thought to play a central role in recruitment of macrophages and monocytes to the lung and to trigger a granulomatous response, including the fusion of macrophages into multinucleated giant cells. Namilumab is an anti-GM-CSF monoclonal antibody formulated to be administered once-monthly as a subcutaneous injection being investigated for the treatment of pulmonary sarcoidosis.
Media
Stephanie Lee
stephanie.lee@roivant.com
FAQ
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