Regeneron to Advance Two Factor XI Antibodies into a Broad Phase 3 Program Following Positive Phase 2 Proof-of-concept Results
Regeneron Pharmaceuticals (NASDAQ: REGN) announced positive Phase 2 results for two novel monoclonal antibodies, REGN7508 and REGN9933, targeting Factor XI for thrombosis control. The trials demonstrated robust antithrombotic effects with no clinically relevant bleeding observed. REGN7508 showed superiority to enoxaparin and non-inferiority to apixaban, while REGN9933 proved non-inferior to enoxaparin in preventing venous thromboembolism after knee surgery.
Key results showed VTE events in 7% of patients for REGN7508, 17% for REGN9933, compared to 21% for enoxaparin and 12% for apixaban. No major bleeding or serious adverse events were reported across all treatment arms. The company plans to initiate Phase 3 trials in 2025.
Regeneron Pharmaceuticals (NASDAQ: REGN) ha annunciato risultati positivi della Fase 2 per due nuovi anticorpi monoclonali, REGN7508 e REGN9933, mirati al Fattore XI per il controllo della trombosi. Gli studi hanno mostrato effetti antitrombotici robusti senza evidenze di emorragie clinicamente significative. REGN7508 ha mostrato superiorità rispetto all'enoxaparina e non inferiorità rispetto all'apixaban, mentre REGN9933 si è dimostrato non inferiore all'enoxaparina nel prevenire la tromboembolia venosa dopo un intervento chirurgico al ginocchio.
I risultati chiave hanno mostrato eventi di TVE nel 7% dei pazienti per REGN7508, 17% per REGN9933, rispetto al 21% per enoxaparina e 12% per apixaban. Non sono stati riportati episodi di emorragia maggiore o eventi avversi gravi in nessun braccio di trattamento. L'azienda prevede di avviare gli studi di Fase 3 nel 2025.
Regeneron Pharmaceuticals (NASDAQ: REGN) anunció resultados positivos de la Fase 2 para dos nuevos anticuerpos monoclonales, REGN7508 y REGN9933, dirigidos al Factor XI para el control de la trombosis. Los ensayos demostraron efectos antitrombóticos sólidos sin observar hemorragias clínicamente relevantes. REGN7508 mostró superioridad frente a la enoxaparina y no inferioridad frente al apixaban, mientras que REGN9933 demostró no ser inferior a la enoxaparina en la prevención de la tromboembolia venosa tras una cirugía de rodilla.
Los resultados clave mostraron eventos de TVE en el 7% de los pacientes para REGN7508, 17% para REGN9933, en comparación con el 21% para enoxaparina y el 12% para apixaban. No se reportaron hemorragias mayores ni eventos adversos graves en ninguno de los brazos de tratamiento. La compañía planea iniciar ensayos de Fase 3 en 2025.
레게너론 제약 (NASDAQ: REGN)은 두 가지 새로운 단클론 항체인 REGN7508과 REGN9933의 2상 긍정적 결과를 발표했습니다. 이 항체들은 혈전 조절을 위해 XI 인자를 표적으로 합니다. 시험 결과는 임상적으로 중요한 출혈이 관찰되지 않는 강력한 항혈전 효과를 보여주었습니다. REGN7508은 에녹사파린에 비해 우수성을 보였고 아픽사반에 대해 동등성을 입증했으며, REGN9933는 무릎 수술 후 정맥 혈전색전증 예방에서 에녹사파린에 비해 동등함을 입증했습니다.
주요 결과는 REGN7508에서 7%, REGN9933에서 17%, 에녹사파린에서 21%, 아픽사반에서 12%의 TVE 사건이 발생했습니다. 모든 치료군에서 주요 출혈이나 심각한 부작용은 보고되지 않았습니다. 이 회사는 2025년에 3상 시험을 시작할 계획입니다.
Regeneron Pharmaceuticals (NASDAQ: REGN) a annoncé des résultats positifs de la Phase 2 pour deux nouveaux anticorps monoclonaux, REGN7508 et REGN9933, ciblant le Facteur XI pour le contrôle de la thrombose. Les essais ont démontré des effets antithrombotiques solides sans aucune hémorragie cliniquement significative observée. REGN7508 a montré une supériorité par rapport à l'enoxaparine et une non-infériorité par rapport à l'apixaban, tandis que REGN9933 a prouvé sa non-infériorité par rapport à l'enoxaparine dans la prévention de la thromboembolie veineuse après une chirurgie du genou.
Les résultats clés ont montré des événements de TVE dans 7% des cas pour REGN7508, 17% pour REGN9933, contre 21% pour l'enoxaparine et 12% pour l'apixaban. Aucun hémorragie majeure ni effet indésirable grave n'a été rapporté dans tous les bras de traitement. L'entreprise prévoit d'initier des essais de Phase 3 en 2025.
Regeneron Pharmaceuticals (NASDAQ: REGN) gab positive Ergebnisse der Phase 2 für zwei neuartige monoklonale Antikörper, REGN7508 und REGN9933, bekannt, die auf Faktor XI zur Kontrolle von Thrombosen abzielen. Die Studien zeigten robuste antithrombotische Effekte, ohne dass klinisch relevante Blutungen beobachtet wurden. REGN7508 zeigte eine Überlegenheit gegenüber Enoxaparin und war nicht unterlegen im Vergleich zu Apixaban, während REGN9933 hinsichtlich der Verhinderung von venösen Thromboembolien nach Knieoperationen nicht unterlegen war im Vergleich zu Enoxaparin.
Wichtige Ergebnisse zeigten VTE-Ereignisse bei 7% der Patienten für REGN7508, 17% für REGN9933, im Vergleich zu 21% für Enoxaparin und 12% für Apixaban. Es wurden keine schweren Blutungen oder schwerwiegenden unerwünschten Ereignisse in allen Behandlungsarmen gemeldet. Das Unternehmen plant, 2025 mit Phase-3-Studien zu beginnen.
- REGN7508 demonstrated superior efficacy to enoxaparin with 7% VTE events vs 21%
- Both antibodies showed no major bleeding or clinically relevant adverse events
- Single-dose administration compared to daily/twice-daily dosing of current treatments
- Phase 3 program advancement planned for 2025
- REGN9933 showed higher VTE events (17%) compared to REGN7508 (7%)
- Both drugs still require regulatory evaluation and approval
Insights
The Phase 2 results for Regeneron's Factor XI antibodies represent a significant breakthrough in anticoagulation therapy. REGN7508 demonstrated superior efficacy to enoxaparin with a
The safety profile is particularly impressive - zero major bleeding events and no treatment-related serious adverse events across all arms. This addresses one of the primary challenges in anticoagulation therapy where efficacy often comes at the cost of increased bleeding risk. The
For investors, the progression to Phase 3 in 2025 represents a major value inflection point. The global anticoagulant market, valued at over
The dual-antibody approach targeting distinct Factor XI domains represents sophisticated drug development strategy. REGN7508's catalytic domain targeting maximizes anticoagulation while REGN9933's A2 domain targeting provides options for high-bleeding-risk patients - effectively creating a portfolio approach to address different patient segments.
The trial design demonstrates scientific rigor by:
- Including active comparators (enoxaparin and apixaban)
- Conducting parallel trials in same centers
- Using clinically relevant post-surgery dosing timing
- Employing objective venogram assessment
Investigational REGN7508 (catalytic domain) and REGN9933 (A2 domain) are being evaluated for their potential to control thrombosis while minimizing bleeding risk in a variety of patient populations and clinical settings
Evaluated against current standards of care, single doses of REGN7508 and REGN9933 administered 12 to 24 hours after total knee replacement demonstrated robust antithrombotic effects
Phase 3 program to be initiated in 2025
TARRYTOWN, N.Y., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive Phase 2 results for two novel monoclonal antibodies targeting distinct domains of Factor XI. REGN7508 (catalytic domain) is designed to maximize anticoagulant activity while minimizing bleeding risk, and REGN9933 (A2 domain) is designed to provide an additional option for patients with the highest bleeding risk who would otherwise not be candidates for currently available anticoagulants. Per the Phase 2 results, there was a robust antithrombotic effect for each antibody, and no clinically relevant bleeding was observed in any treatment arm.
“Our Factor XI antibodies targeting the catalytic and A2 domains were rigorously evaluated alongside current standards of care and showed clear evidence of antithrombotic effect with an encouraging safety profile after a convenient single dose,” said George D. Yancopoulos, M.D., Ph.D., Board Co-Chair, President and Chief Scientific Officer at Regeneron. “These latest Phase 2 results add to our preclinical data that showed prolongation of activated partial thromboplastin clotting time was greater with REGN7508 and similar with REGN9933, compared to other Factor XI-targeted agents. Together, these clinical and preclinical data, along with compelling genetic evidence, give us confidence in targeting multiple distinct domains of Factor XI to potentially offer tailored therapies for patients with different bleeding risk profiles and in a variety of treatment settings. We are eager to advance REGN7508 and REGN9933 into a broad Phase 3 program beginning in 2025.”
Regeneron conducted two open-label, active-controlled Phase 2 trials (ROXI-VTE-I and ROXI-VTE-II) in the same centers under similar protocols to evaluate REGN7508 and REGN9933 for the prevention of asymptomatic (detected by venogram between day 8 and 12) or symptomatic venous thromboembolism (VTE) after unilateral total knee arthroplasty. In ROXI-VTE-I, patients were randomized to receive either a single intravenous (IV) dose of REGN9933, daily enoxaparin, or twice daily doses of apixaban until the time of venography. In ROXI-VTE-II, patients were randomized to receive a single IV dose of REGN7508 or daily enoxaparin until the time of venography. In contrast to trials evaluating other Factor XI antibodies, administration of all treatments began 12 to 24 hours after surgery (generally one day post-operation) in both trials, consistent with the approved administration of the active comparators.
On the measure of VTE rates at venogram following surgery, a pooled analysis across both trials showed REGN7508 was superior to enoxaparin and non-inferior to apixaban, and REGN9933 was non-inferior to enoxaparin. All VTE events were asymptomatic, except for one symptomatic case of pulmonary embolism in the apixaban arm. Results were as follows:
| REGN7508 | REGN9933 | enoxaparin | apixaban | Historical control (placebo)1 | ||
| Patients with VTE events | (8 of 113 patients) | (20 of 116 patients) | (36 of 175 patients) | (14 of 113 patients) | (43 of 89 patients) | |
| Difference in VTE incidence ( | REGN7508 vs enoxaparin: - REGN7508 vs apixaban: - REGN9933 vs enoxaparin: - | |||||
* Superiority met
^ Non-inferiority met with a margin of
There was no major bleeding (including surgical site bleeding) or clinically relevant non-major bleeding in any arm; the only treatment-related adverse events (AE) in any arm was one case of minimal bleeding (contusion) reported in the enoxaparin arm of ROXI-VTE-I.
There were no treatment-related serious AEs (SAEs) in any arm. There were also no AEs in any arm leading to trial discontinuation or dose interruption/modification, and no AEs of special interest or deaths in these trials. Across both trials, AE rates were generally similar among the treatment arms (ROXI-VTE-I: REGN9933=
The safety and efficacy of REGN7508 and REGN9933 have not been evaluated by any regulatory authority.
About Thrombosis
Thrombosis, otherwise known as clot formation, is responsible for one in four deaths worldwide. Due to bleeding concerns, current standard-of-care anticoagulants are underutilized and current oral agents are often associated with poor adherence. There is an unmet need for treatments that can help prevent thrombosis without increased bleeding risk.
About Regeneron's VelocImmune® Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara®, Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). In addition, REGEN-COV® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for over 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center®, which is conducting one of the largest genetics sequencing efforts in the world.
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn.
Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation REGN7508 and REGN9933, two novel monoclonal antibodies targeting distinct domains of Factor XI (together, the “Factor XI Product Candidates”); uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates (such as any of the Factor XI Product Candidates); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as any regulatory approval of any of the Factor XI Product Candidates; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as any of the Factor XI Product Candidates) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates (including biosimilar versions of Regeneron’s Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees (including the Phase 2 studies evaluating the Factor XI Product Candidates discussed in this press release) may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron's business; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2023 and its Form 10-Q for the quarterly period ended September 30, 2024. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals).
| Contacts: Regeneron Media Relations Mary Heather Tel: +1 914-847-8650 mary.heather@regeneron.com | Investor Relations Mark Hudson Tel: +1 914-847-3482 mark.hudson@regeneron.com |
1 Fuji T, Fujita S, Tachibana S, Kawai Y. A dose-ranging study evaluating the oral factor Xa inhibitor edoxaban for the prevention of venous thromboembolism in patients undergoing total knee arthroplasty. J Thromb Haemost. 2010 Nov;8(11):2458-68. doi: 10.1111/j.1538-7836.2010.04021.x. PMID: 20723033.
FAQ
What were the key Phase 2 results for REGN7508 and REGN9933?
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