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HORGEN, Switzerland--(BUSINESS WIRE)--Numab Therapeutics AG (Numab), a clinical stage biotechnology company advancing a proprietary pipeline of immunology and oncology therapeutics, announced today that the first patient has been dosed in the multiple ascending dose (MAD) study of the Phase 1a/b clinical trial of NM26, a first-in-class bi-specific antibody for the treatment of moderate-to-severe atopic dermatitis (AD)..
瑞士HORGEN-(BUSINESS WIRE)-Numab Therapeutics AG(Numab)是一家临床阶段生物技术公司,致力于推进免疫学和肿瘤学治疗学的专有管道,今天宣布第一名患者已多次递增剂量(MAD)研究NM26的1a/b期临床试验,用于治疗中度至重度特应性皮炎(AD)的一流双特异性抗体。。
The MAD study in AD patients is a planned continuation of the Company’s ongoing single ascending dose (SAD) portion of the Phase 1a/b trial in healthy volunteers. NM26 is designed to simultaneously block itch and inflammation by inhibiting the three key cytokine-signaling pathways involved in disease pathogenesis of AD: IL-4, IL-13, and IL-31, the latter specifically targeting the neuroinflammatory pathway that causes itch..
AD患者的MAD研究是该公司正在进行的健康志愿者1a/b期试验单次递增剂量(SAD)部分的计划延续。NM26旨在通过抑制参与AD疾病发病机理的三个关键细胞因子信号传导途径同时阻断瘙痒和炎症:IL-4,IL-13和IL-31,后者专门针对引起瘙痒的神经炎症途径。。
“Dosing the first patient with NM26 represents a major milestone for Numab as we advance development of NM26 in atopic dermatitis and potentially other inflammatory and immune-mediated diseases,” said David Urech, Ph.D., Founder and Chief Executive Officer of Numab Therapeutics. “We believe that NM26 has the potential to deliver faster relief from itch and more pronounced improvement of skin lesions than the current standard of care and therefore provide a more effective therapeutic option for patients.
Numab Therapeutics的创始人兼首席执行官David Urech博士说:“随着我们推动NM26在特应性皮炎和潜在的其他炎症和免疫介导的疾病中的发展,给第一位NM26患者服用NM26代表了Numab的一个重要里程碑。“我们相信NM26有可能比目前的护理标准更快地缓解瘙痒和更明显地改善皮肤病变,因此为患者提供更有效的治疗选择。
We look forward to evaluating the potential of NM26 and expect to report preliminary data from the MAD part of the study in mid-2024.”.
我们期待评估NM26的潜力,并期望在2024年中期报告该研究的MAD部分的初步数据。
AD is an inflammatory skin condition which is characterized by a vicious cycle of skin inflammation that causes itching and scratching, the latter in turn exacerbates damage to the skin barrier and inflammation and furthers itching, resulting in the characteristic skin lesions for which AD is known.
AD是一种炎症性皮肤病,其特征在于引起瘙痒和抓挠的皮肤炎症的恶性循环,后者又加剧对皮肤屏障和炎症的损害并进一步瘙痒,导致已知AD的特征性皮肤损伤。
In the United States and the European Union markets, approximately 17-26 million patients suffer from moderate-to-severe AD..
在美国和欧盟市场,约有1700万至2600万患者患有中度至重度AD。。
The Phase 1a/1b trial is a randomized, double-blind, placebo-controlled study of subcutaneous (SC) administration of NM26 in healthy volunteers and adult patients with moderate-to-severe AD to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single and multiple ascending doses of NM26 as well as exploratory clinical activity in the MAD part of the trial.
1a/1b期试验是一项随机,双盲,安慰剂对照研究,在健康志愿者和中度至重度AD成人患者中皮下(SC)给予NM26,以评估其安全性,耐受性,药代动力学和免疫原性。单次和多次递增剂量的NM26以及试验MAD部分的探索性临床活动。
The trial is being conducted in collaboration with Asia-regional partner Kaken Pharmaceutical. For additional information on this trial (NCT05859724), please visit www.clinicaltrials.gov..
该试验正在与亚洲区域合作伙伴Kaken Pharmaceutical合作进行。有关此试验的更多信息(NCT05859724),请访问www.clinicaltrials.gov。。
About NM26 (NM26-2198)
关于NM26(NM26-2198)
NM26 is a bi-specific antibody which targets IL-4Rα (type I and type II receptors) and IL-31 for the treatment of atopic dermatitis (AD). The antibody therapeutic is designed to prevent IL- 4/IL-13 and IL-31-induced keratinocyte immunopathology, immune cell activation, skin barrier function impairment and pruritis, all of which are hallmarks of the pathophysiology of atopic dermatitis.
NM26是靶向IL-4Rα(I型和II型受体)和IL-31用于治疗特应性皮炎(AD)的双特异性抗体。抗体治疗剂旨在预防IL-4/IL-13和IL-31诱导的角质形成细胞免疫病理学,免疫细胞活化,皮肤屏障功能障碍和瘙痒症,所有这些都是特应性皮炎病理生理学的标志。
Addition of IL-31 mediated blockade of neuroinflammation to the repression of Th2 driven inflammation by IL-4/IL-13 blockade is expected to enable a faster onset of action and demonstrate superior efficacy over current and emerging standard of care in AD, together with convenient subcutaneous administration.
预期通过IL-4/IL-13阻断添加IL-31介导的神经炎症阻断以抑制Th2驱动的炎症能够更快地起效并且表现出优于当前和新兴的AD护理标准的功效,以及方便的皮下给药。
Numab is developing this molecule together with its regional partner Kaken Pharmaceutical, which owns commercial rights to certain Asian territories, including Japan..
Numab正在与其区域合作伙伴Kaken Pharmaceutical一起开发这种分子,Kaken Pharmaceutical拥有包括日本在内的某些亚洲领土的商业权利。。
About Numab Therapeutics
关于Numab疗法
Numab Therapeutics is an immunology and oncology-focused biopharmaceutical company based in Zurich-area, Switzerland. At Numab, we are writing the next chapter in addressing unmet needs in inflammatory diseases and cancer immunotherapy by creating multi-specific antibodies that enable the pursuit of novel therapeutic strategies.
Numab Therapeutics是一家总部设在瑞士苏黎世地区的免疫学和肿瘤学生物制药公司。在Numab,我们将通过创建能够追求新治疗策略的多特异性抗体,撰写下一章,以解决炎症性疾病和癌症免疫治疗中未满足的需求。
With our proprietary MATCH technology platform, we are fueling a new wave of multi-specific drug candidates engineered with versatility and developability in mind. We believe meeting the highest quality standards in every step of the drug design process matters and will result in better patient outcomes.
凭借我们专有的匹配技术平台,我们正在推动一波设计具有多功能性和可开发性的多特异性候选药物。我们相信,在药物设计过程的每一步都能达到最高质量标准,并能带来更好的患者结果。
For further information, visit www.numab.com..
欲了解更多信息,请访问www.numab.com。。
About Kaken Pharmaceutical
关于Kaken Pharmaceutical
Kaken is an R&D driven pharmaceutical company, established in 1948, and its corporate philosophy is to help improve the quality of life of patients by serving as many people as possible to return smiles of happiness to their faces, through supplying superior pharmaceuticals. Recently, Kaken has increased its presence in dermatology and orthopedics, and Clenafin, a drug discovered in-house and first topical onychomycosis treatment in Japan, continues to grow as a global product.
Kaken是一家由研发驱动的制药公司,成立于1948年,其公司理念是通过提供优质药品,尽可能多的人将快乐的微笑返回到脸上,帮助改善患者的生活质量。最近,Kaken增加了其在皮肤科和整形外科的应用,Clenafin是日本内部和首次局部甲真菌病治疗发现的药物,作为全球产品继续增长。
For more information, please visit https://www.kaken.co.jp/english/..
欲了解更多信息,请访问https://www.kaken.co.jp/english/..