Preclinical Data Demonstrate Anti-Siglec-15 Treatment Improves Bone Microarchitecture and Reduces Fracture Incidence in Mice with Moderate-to-Severe Osteogenesis Imperfecta
NextCure (Nasdaq: NXTC) presented promising preclinical data for NC605, their novel anti-Siglec-15 antibody treatment for osteogenesis imperfecta (OI), also known as brittle bone disease. The study demonstrated that NP159 (the murine version of NC605) improved bone microarchitecture and reduced fracture incidence compared to anti-sclerostin treatment in OI mice.
Key findings showed that weekly treatment with 20 mg/kg of NP159 increased cortical and trabecular bone mineral density, tissue mineral density, and cortical thickness while decreasing trabecular separation compared to control groups. The research was conducted in collaboration with Dr. Cathleen Raggio from Hospital for Special Surgery, New York. NextCure is now seeking financial partners to advance NC605 toward an IND submission within 12-18 months.
NextCure (Nasdaq: NXTC) ha presentato dati preclinici promettenti per NC605, il loro nuovo anticorpo anti-Siglec-15 per il trattamento dell'osteogenesi imperfetta (OI), nota anche come malattia delle ossa fragili. Lo studio ha dimostrato che NP159 (la versione murina di NC605) ha migliorato la microarchitettura ossea e ridotto l'incidenza delle fratture rispetto al trattamento con anti-sclerostina nei topi con OI.
I risultati chiave hanno evidenziato che il trattamento settimanale con 20 mg/kg di NP159 ha aumentato la densità minerale ossea corticale e trabecolare, la densità minerale del tessuto e lo spessore corticale, riducendo al contempo la separazione trabecolare rispetto ai gruppi di controllo. La ricerca è stata condotta in collaborazione con la dottoressa Cathleen Raggio dell'Hospital for Special Surgery di New York. NextCure sta ora cercando partner finanziari per portare NC605 alla presentazione di una IND entro 12-18 mesi.
NextCure (Nasdaq: NXTC) presentó datos preclínicos prometedores para NC605, su nuevo anticuerpo anti-Siglec-15 para el tratamiento de la osteogénesis imperfecta (OI), también conocida como enfermedad de los huesos frágiles. El estudio demostró que NP159 (la versión murina de NC605) mejoró la microarquitectura ósea y redujo la incidencia de fracturas en comparación con el tratamiento anti-esclerostina en ratones con OI.
Los hallazgos clave mostraron que el tratamiento semanal con 20 mg/kg de NP159 aumentó la densidad mineral ósea cortical y trabecular, la densidad mineral del tejido y el grosor cortical, mientras disminuía la separación trabecular en comparación con los grupos de control. La investigación se realizó en colaboración con la Dra. Cathleen Raggio del Hospital for Special Surgery en Nueva York. NextCure ahora busca socios financieros para avanzar con NC605 hacia una presentación IND en un plazo de 12-18 meses.
NextCure (나스닥: NXTC)는 골형성부전증(OI)으로도 알려진 골연화증 치료를 위한 신형 항-Siglec-15 항체 치료제 NC605에 대한 유망한 전임상 데이터를 발표했습니다. 연구 결과, NP159(NC605의 마우스 버전)가 OI 마우스에서 항-스클레로스틴 치료에 비해 뼈 미세구조를 개선하고 골절 발생을 감소시켰습니다.
주요 결과는 주 1회 20 mg/kg NP159 투여가 피질 및 해면골 골밀도, 조직 광물 밀도, 피질 두께를 증가시키고 해면골 간격을 줄였음을 보여주었습니다. 이 연구는 뉴욕 특수 수술 병원의 Cathleen Raggio 박사와 협력하여 진행되었습니다. NextCure는 현재 NC605를 12-18개월 내 IND 제출 단계로 발전시키기 위해 재정 파트너를 찾고 있습니다.
NextCure (Nasdaq : NXTC) a présenté des données précliniques prometteuses pour NC605, leur nouvel anticorps anti-Siglec-15 destiné au traitement de l'ostéogenèse imparfaite (OI), également connue sous le nom de maladie des os fragiles. L'étude a démontré que NP159 (la version murine de NC605) améliorait la microarchitecture osseuse et réduisait l'incidence des fractures par rapport au traitement anti-sclérostine chez des souris atteintes d'OI.
Les résultats clés ont montré qu'un traitement hebdomadaire avec 20 mg/kg de NP159 augmentait la densité minérale osseuse corticale et trabéculaire, la densité minérale tissulaire et l'épaisseur corticale tout en diminuant la séparation trabéculaire par rapport aux groupes témoins. La recherche a été menée en collaboration avec le Dr Cathleen Raggio de l'Hospital for Special Surgery à New York. NextCure recherche désormais des partenaires financiers pour faire avancer NC605 vers une soumission IND dans un délai de 12-18 mois.
NextCure (Nasdaq: NXTC) präsentierte vielversprechende präklinische Daten zu NC605, ihrem neuartigen Anti-Siglec-15-Antikörper zur Behandlung der Osteogenesis imperfecta (OI), auch bekannt als Glasknochenkrankheit. Die Studie zeigte, dass NP159 (die murine Version von NC605) die Knochenmikroarchitektur verbesserte und die Frakturrate im Vergleich zur Anti-Sclerostin-Behandlung bei OI-Mäusen verringerte.
Wichtige Ergebnisse zeigten, dass eine wöchentliche Behandlung mit 20 mg/kg NP159 die kortikale und trabekuläre Knochenmineraldichte, die Gewebemineraldichte und die kortikale Dicke erhöhte und gleichzeitig die trabekuläre Separation im Vergleich zu Kontrollgruppen verringerte. Die Forschung wurde in Zusammenarbeit mit Dr. Cathleen Raggio vom Hospital for Special Surgery in New York durchgeführt. NextCure sucht nun finanzielle Partner, um NC605 innerhalb von 12-18 Monaten für eine IND-Einreichung weiterzuentwickeln.
- Preclinical data showed improved bone microarchitecture and reduced fracture incidence
- NC605 demonstrated dual action: inhibiting bone loss while producing new bone with increased quality
- Results were comparable to anti-sclerostin treatment, suggesting competitive efficacy
- Potential first-in-class treatment for an indication with no FDA-approved standard of care
- Company requires external financial support to advance NC605 to IND stage
- Early-stage development (preclinical) indicates long pathway to potential commercialization
Insights
Promising preclinical data for NC605 in treating brittle bone disease shows potential but faces funding hurdles for clinical development.
The preclinical data for NextCure's anti-Siglec-15 antibody (NC605) represents a potentially significant advancement in the treatment landscape for osteogenesis imperfecta (OI). The results demonstrate a dual mechanism of action - inhibiting bone loss while simultaneously promoting new bone formation with improved quality and density - which addresses key limitations of existing therapies.
What's particularly notable is NC605's performance against anti-sclerostin treatment, showing comparable or better outcomes in improving trabecular and cortical bone density while reducing fracture incidence. Current anti-resorptive treatments for OI increase bone density but result in poor overall bone quality by inhibiting both bone loss and formation. NC605's differentiated mechanism could potentially overcome this fundamental limitation.
The unmet medical need here is substantial - OI has no FDA-approved standard of care, and patients suffer from recurrent fractures and bone fragility that significantly impact quality of life. However, NextCure faces a critical funding challenge, explicitly stating they require external financial support to advance NC605 toward an IND submission within 12-18 months. This indicates the program is not a near-term priority for their internal resource allocation, which is likely focused on their oncology pipeline.
For investors, while these results are promising, the 12-18 month timeline to just reach IND stage means commercialization remains distant. The company's explicit search for external funding signals they're not committing significant resources to this program without partnership support, creating uncertainty about NC605's development pathway.
BELTSVILLE, Md., July 24, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer, today announced the presentation of new preclinical data in a well-established model of osteogenesis imperfecta (OI) demonstrating that treatment with NC605, a novel anti-Siglec-15 antibody, achieved improved bone microarchitecture and reduced fracture incidence compared to anti-sclerostin treatment. The data were presented at the Brittle Bone Society Meeting on July 24th, 2025. These results demonstrate that NC605 could be a highly effective treatment for OI, also known as brittle bone disease.
OI is a rare disorder that results in high bone turnover, abnormal bone formation, bone fragility and recurrent fractures. There is no cure for OI. Current anti-resorptive treatments inhibit both bone loss and bone formation leading to an increase in bone density, but overall poor bone quality. In contrast, NC605 has been shown to inhibit bone loss and to produce new bone, with increased quality and density.
Fracture incidence and bone architecture were assessed in male and female OI mice treated with weekly 20 mg/kg of surrogate antibody NP159 (murine mAb parent to NC605) and compared to control groups treated with twice weekly 50 mg/kg anti-sclerostin or saline. NP159 increased cortical and trabecular bone mineral density, tissue mineral density, cortical thickness and decreased trabecular separation compared to saline-treated mice.
“In a mouse model of moderate-to-severe OI, NP159, a surrogate murine antibody for NC605, improved trabecular and cortical bone density and reduced fracture incidence comparable to anti-sclerostin,” said Priyanka Kothari, Ph.D., NextCure’s Director, Translational Research. “There is currently no standard of care approved by the FDA for patients with OI and NC605 has the potential to provide significant therapeutic benefit for patients.”
The data were generated in collaboration with Dr. Cathleen Raggio, Hospital for Special Surgery, New York.
NextCure is seeking financial support from partners or third parties to advance NC605 to a possible Investigational New Drug submission within 12 to 18 months.
About NextCure, Inc.
NextCure is a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients that do not respond to, or have disease progression on, current therapies, through the use of differentiated mechanisms of actions including antibody-drug conjugates, antibodies and proteins. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells, including in the tumor microenvironment, and the role each interaction plays in a biologic response. http://www.nextcure.com
Cautionary Statement Regarding Forward-Looking Statements
Statements made in this press release that are not historical facts are forward-looking statements. Words such as “expects,” “believes,” “intends,” “hope,” “forward” and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: our limited operating history and no products approved for commercial sale; our history of significant losses; our need to obtain additional financing; risks related to clinical development, including that early clinical data may not be confirmed by later clinical results; risks that pre-clinical research may not be confirmed in clinical trials; risks related to marketing approval and commercialization; and NextCure’s dependence on key personnel. More detailed information on these and additional factors that could affect NextCure’s actual results are described in NextCure’s filings with the Securities and Exchange Commission (the “SEC”), including NextCure’s most recent Form 10-K and subsequent Form 10-Q. You should not place undue reliance on any forward-looking statements. NextCure assumes no obligation to update any forward-looking statements, even if expectations change.
Investor Inquiries
Timothy Mayer, Ph.D.
NextCure, Inc.
Chief Operating Officer
(240) 762-6486
IR@nextcure.com
FAQ
What were the key findings of NextCure's (NXTC) NC605 preclinical trial for osteogenesis imperfecta?
How does NextCure's NC605 treatment differ from current osteogenesis imperfecta treatments?
What is the development timeline for NextCure's (NXTC) NC605 treatment?
What dosing regimen was used in NextCure's preclinical study of NC605?
What is the current treatment landscape for osteogenesis imperfecta?
