LAUSANNE, Switzerland--(BUSINESS WIRE)--Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to develop innovative therapies and to improve patient quality of life, today announced the dosing of the first sentinel patients in its open-label, single-arm, multi-center Phase III study, NCT06129539 ‘A Study to Assess the Efficacy, Safety and Pharmacokinetics of Debio 4326 in Pediatric Participants Receiving Gonadotropin-Releasing Hormone Agonist Therapy for Central Precocious Puberty (LIBELULA)’.

瑞士洛桑--（商业新闻短讯）--Debiopharm（www.Debiopharm.com）是一家总部位于瑞士的私营生物制药公司，旨在开发创新疗法并改善患者生活质量，今天宣布在其开放标签，单臂，多中心III期研究NCT06129539“一项评估Debio 4326在接受促性腺激素释放激素激动剂治疗中枢性早熟（LIBELULA）的儿科参与者中的有效性，安全性和药代动力学的研究”中，首批哨兵患者的剂量。

Triptorelin is an established treatment for CPP as a 1-, 3- and 6-month formulation. This new phase III study evaluating the novel 12-month triptorelin formulation is being carried out in North and South America..

曲普瑞林是CPP的既定治疗方法，可用于1个月，3个月和6个月的配方。这项评估新型12个月曲普瑞林制剂的新的III期研究正在北美和南美进行。。

In pursuit of developing safe, effective, and convenient treatment options for patients, Debiopharm, is applying its expertise in extended-release formulations to achieve the first yearly injectable Gonadotropin-Releasing Hormone agonist (GnRHa). Reducing treatment burden while preserving triptorelin’s well-known efficacy and safety are key elements that Debiopharm is eager to assess through this study..

为了为患者开发安全，有效和方便的治疗选择，Debiopharm正在将其专业知识应用于缓释制剂，以实现第一种每年注射的促性腺激素释放激素激动剂（GnRHa）。在保持曲普瑞林众所周知的疗效和安全性的同时减轻治疗负担是Debiopharm渴望通过这项研究评估的关键因素。。

“It is always disheartening to see such young children burdened by the effects of central precocious puberty and the lifelong complications it may cause. We are thankful that treatments like triptorelin are already on the market, and that companies like Debiopharm continue to invest in lightening the patient care burden with formulations that reduce injection frequency,” expressed Prof.

“看到这些年幼的孩子受到中枢性早熟的影响及其可能导致的终身并发症的困扰，总是令人沮丧的。我们感谢曲普瑞林等治疗药物已经上市，Debiopharm等公司继续投资减少注射频率的配方来减轻患者护理负担，”教授表示。

Fernando Cassorla, Principal Investigator, Pediatrics Department at the Hospital San Borja Arriarán in Santiago, Chile..

费尔南多·卡索拉（FernandoCassorla），智利圣地亚哥圣博贾·阿里安医院儿科首席研究员。。

“As patients are at the center of all we do, we recognize that convenience matters. Reducing injection frequency to once a year can lower the burden for CPP patients and their caretakers by reducing children’s stress and improving overall compliance. We are enthusiastic about the first patients enrolled in this phase III trial that can bring both medical and practical advancements,” expressed Bertrand Ducrey, CEO of Debiopharm..

Debiopharm首席执行官伯特兰·杜克雷（BertrandDucrey）表示：“由于患者是我们所有工作的中心，我们认识到便利性很重要。将注射频率降低到每年一次可以通过减轻儿童压力和提高整体依从性来减轻CPP患者及其护理人员的负担。我们对第一批参加这项III期试验的患者充满热情，这项试验可以带来医学和实践方面的进步。”。。

About Central Precocious Puberty

关于中枢性性早熟

Central precocious puberty (CPP) occurs at an unusually early age, before 8 years of age in girls and before 9 years of age in boys [1-2]. It is characterized by a premature development of secondary sexual characteristics (e.g. breasts for girls and enlarged testicles for boys), accelerated growth, and bone maturation leading to reduced adult height.

中枢性早熟（CPP）发生在异常早期，女孩在8岁之前，男孩在9岁之前[1-2]。它的特征是第二性征过早发育（例如女孩的乳房和男孩的睾丸增大），生长加速和骨骼成熟导致成人身高降低。

CPP is triggered by the early release of the gonadotropin-releasing hormone in the brain and premature activation of the hypothalamic-pituitary-gonadal axis. This early activation can be due to specific genetic alterations, central nervous system lesions, and social stressors but frequently has no identified etiology [3].

CPP是由大脑中促性腺激素释放激素的早期释放和下丘脑-垂体-性腺轴的过早激活触发的。这种早期激活可能是由于特定的遗传改变，中枢神经系统病变和社会压力，但通常没有确定的病因〔3〕。

The approximative prevalence of CPP is 1 in 5,000-10,000 among Caucasians, more frequent in girls than in boys globally [4]. Precocious puberty may be associated with psychosocial difficulties and carries potential negative implications for long-term health including increased risk of metabolic complications, such as type 2 diabetes, weight gain, obesity, cardiovascular disease, as well as depression, and even premature death [5-10].

高加索人中CPP的近似患病率为5000-10000分之一，在全球范围内，女孩比男孩更常见（4）。性早熟可能与心理社会困难有关，并对长期健康产生潜在的负面影响，包括增加代谢并发症的风险，如2型糖尿病、体重增加、肥胖、心血管疾病以及抑郁症，甚至过早死亡。

Early puberty has also been associated with an increased risk of breast cancer in women. In men, it may increase the risk of prostate cancer [11-13]. Since the early 1980s, Gonadotropin-Releasing Hormone agonists (GnRHa) such as triptorelin have been the standard of care for the treatment of CPP [14-16].

青春期早期也与女性患乳腺癌的风险增加有关。。自20世纪80年代初以来，促性腺激素释放激素激动剂（GnRHa）如曲普瑞林一直是治疗CPP的标准治疗方法[14-16]。

Treatment aims to preserve adult height and prevent social and psychological difficulties and the various potential consequences on long-term health. Currently, there are several different extended-release GnRHa formulations ranging from monthly injections to subcutaneous implants for annual use [17].

治疗的目的是保持成年人的身高，防止社会和心理困难以及对长期健康的各种潜在后果。目前，有几种不同的缓释GnRHa制剂，从每月注射到每年使用的皮下植入物（17）。

While the latter may have a longer duration of action, it requires yearly su.

虽然后者可能有更长的行动持续时间，但它需要每年的su。

About Debio 4326

关于Debio 4326

Debio 4326 is a unique injectable, biodegradable 12-month extended-release formulation of triptorelin designed to further reduce the frequency of injections and burden of administrations, particularly considering its intended use in a pediatric population. Based on favorable efficacy and safety data with the different triptorelin 1-, 3- and 6-month formulations, Debio 4326 aims to preserve efficacy while providing increased comfort, ensure long-term compliance, and reduce stress for children and their parents..

Debio 4326是一种独特的可注射，可生物降解的曲普瑞林12个月缓释制剂，旨在进一步减少注射频率和给药负担，特别是考虑到其在儿科人群中的预期用途。基于不同曲普瑞林1、3和6个月配方的良好疗效和安全性数据，Debio 4326旨在保持疗效，同时提供更高的舒适度，确保长期依从性，并减轻儿童及其父母的压力。。

Debiopharm's commitment to patients

Debiopharm对患者的承诺

Debiopharm aims to develop innovative therapies that target high unmet medical needs primarily in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy, and then hand stewardship to large pharmaceutical commercialization partners to maximize patient access globally..

Debiopharm旨在开发创新疗法，主要针对肿瘤学和细菌感染的高度未满足的医疗需求。弥合破坏性发现产品与现实世界患者接触之间的差距，我们确定了用于许可的高潜力化合物和技术，临床证明了它们的安全性和有效性，然后将管理工作交给大型药物商业化合作伙伴，以最大程度地提高全球患者的接触率。。

For more information, please visit www.debiopharm.com

有关更多信息，请访问www.debiopharm.com

We are on X. Follow us @DebiopharmNews at http://twitter.com/DebiopharmNews

我们在X上关注我们@DebiopharmNewshttp://twitter.com/DebiopharmNews

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