SHANGHAI, Dec. 13, 2023 /PRNewswire/ -- Alebund Pharmaceuticals ('Alebund' or the 'Company'), an integrated biopharmaceutical company focusing on developing innovative therapies for the treatment of renal diseases and related chronic conditions, announced phase II proof-of-concept study results for the investigational drug, AP306, a first-in-class, pan-inhibitor of sodium-dependent phosphate transporters, which was discovered by  Chugai Pharmaceutical Co., Ltd., and previously referred by EOS789..

上海，2023年12月13日/PRNewswire/--Alebund Pharmaceuticals（“Alebund”或“公司”）是一家综合性生物制药公司，专注于开发治疗肾脏疾病和相关慢性病的创新疗法，宣布了研究药物AP306的第二阶段概念验证研究结果，钠依赖性磷酸盐转运蛋白的泛抑制剂，由Chugai Pharmaceutical Co.，Ltd.发现，之前由EOS789提及。。

In this phase II study (NCT05764590), patients on maintenance hemodialysis with hyperphosphatemia (n=55) were 1:1 randomized to AP306 or sevelamer carbonate after a washout period. Patients on AP306 followed a dose titration schedule from 75mg TID to 150mg TID per protocol during the 12-week treatment.

在这项II期研究（NCT05764590）中，维持性血液透析伴高磷血症（n=55）的患者在冲洗期后以1:1的比例随机分为AP306或司维拉姆碳酸酯。在12周的治疗期间，AP306患者按照每个方案从75mg TID到150mg TID的剂量滴定时间表。

Patients on sevelamer carbonate followed dose titration from 800mg TID per its package insert. The primary endpoint was the change in serum phosphorus from baseline to end of treatment. At the end of treatment, the effect size of serum phosphorus reduction from baseline for AP306 was clinically significant; and the response rate (defined as serum phosphorus lower than 5.5 mg/dL) in AP306 treatment arm was much higher in comparison to that in sevelamer carbonate arm.

服用碳酸司维拉姆的患者按照其包装说明书从800mg TID开始进行剂量滴定。主要终点是血清磷从基线到治疗结束的变化。在治疗结束时，AP306从基线降低血清磷的效果大小具有临床意义；AP306治疗组的缓解率（定义为血清磷低于5.5 mg/dL）远高于碳酸司维拉姆组。

AP306 was well tolerated with no unexpected safety findings observed. Detailed results from this phase II study will be presented at an upcoming medical conference..

AP306耐受性良好，未观察到意外的安全性发现。第二阶段研究的详细结果将在即将举行的医学会议上介绍。。

Dr. Sharon Moe, from the Indiana University School of Medicine, an internationally recognized researcher and key opinion leader for chronic kidney disease-mineral and bone disorder (CKD-MBD), will chair the steering committee of AP306 program, working closely with Alebund to continue its clinical development. Dr.

来自印第安纳大学医学院的Sharon Moe博士是国际公认的慢性肾脏疾病矿物质和骨骼疾病（CKD-MBD）研究人员和关键意见领袖，将担任AP306项目指导委员会主席，与Alebund密切合作，继续其临床开发。博士。

Moe has been principal investigators for several ongoing basic and clinical research studies in the field of CKD-MBD and was the leading investigator for AP306 (EOS789) phase 1b study..

Moe一直是CKD-MBD领域几项正在进行的基础和临床研究的主要研究者，也是AP306（EOS789）1b期研究的主要研究者。。

'Hyperphosphatemia remains a significant clinical problem in patients undergoing dialysis but with suboptimal control despite widespread use of phosphate binders. Treatment of AP306, a pan-inhibitor of PiT1 and PiT2 in addition to NaPi2b, achieved a higher serum phosphorus reduction with a lower pill burden than phosphate binder.  Encouraged by the data from this proof-of-concept study, AP306 is promising for substantially improving phosphate control in dialysis patients with hyperphosphatemia.' said Dr.

“高磷血症仍然是接受透析的患者的一个重大临床问题，但尽管广泛使用磷酸盐结合剂，但控制不佳。除NaPi2b外，AP306（一种PiT1和PiT2的泛抑制剂）的治疗实现了比磷酸盐粘合剂更高的血清磷降低和更低的药丸负担。受这项概念验证研究数据的鼓舞，AP306有望大大改善高磷血症透析患者的磷酸盐控制。”博士说。

Jin Tian, Co-founder and CMO of Alebund..

Alebund联合创始人兼首席营销官金田。。

'We are delighted to see the phase II data of AP306,' Dr. Gavin Xia, Co-founder, Chairman and CEO of Alebund commented, 'These results strengthen our confidence that AP306 could be a novel treatment for patients with hyperphosphatemia as a single agent. With AP301 (phase III ongoing) and AP306, we have a global leading hyperphosphatemia portfolio, which will address the huge unmet needs for hyperphosphatemia management.'.

“我们很高兴看到AP306的II期数据，”Alebund联合创始人、董事长兼首席执行官加文·夏博士评论道，“这些结果增强了我们的信心，即AP306可能作为单一药物治疗高磷血症患者。通过AP301（正在进行第三阶段）和AP306，我们拥有全球领先的高磷血症组合，将解决高磷血症管理的巨大未满足需求。”。

About Hyperphosphatemia

关于高磷血症

Hyperphosphatemia is one of the most common complications in CKD patients. The long-term elevated serum phosphorus level could cause multiple complications such as secondary hyperparathyroidism, renal osteodystrophy and vascular calcification. It is an independent risk factor of cardiovascular events and all-cause mortalities.

高磷血症是CKD患者最常见的并发症之一。长期血清磷水平升高可能导致多种并发症，例如继发性甲状旁腺功能亢进，肾性骨营养不良和血管钙化。它是心血管事件和全因死亡率的独立危险因素。

A good control of serum phosphorus level could effectively improve the patients' outcome. For CKD patients undergoing dialysis treatment, the regular dialysis is not sufficient to remove the overload of serum phosphate in the body. Considering the limitations of low-phosphate diet which might cause dystrophia, oral use of phosphate binders is the prevailing treatment for hyperphosphatemia.

良好的血磷水平控制可以有效改善患者的预后。对于接受透析治疗的CKD患者，定期透析不足以消除体内血清磷酸盐的超负荷。考虑到低磷饮食可能导致营养不良的局限性，口服磷酸盐结合剂是高磷血症的主要治疗方法。

However, less than 50% can maintain reaching a good phosphate control with current treatment options..

然而，通过目前的治疗方案，不到50%的患者可以保持良好的磷酸盐控制。。

About the study

关于这项研究

NCT05764590 is a phase II randomized, open-label, active-controlled, multicenter study to evaluate the safety and serum phosphorus lowering effect of AP306 in chronic kidney disease patients receiving maintenance hemodialysis with hyperphosphatemia. The primary efficacy endpoint measures the change in serum phosphorus level from the baseline to the end of 12-week treatment or before the initiation of rescue therapy.

NCT05764590是一项II期随机，开放标签，主动对照，多中心研究，旨在评估AP306在接受高磷血症维持性血液透析的慢性肾脏病患者中的安全性和血清磷降低效果。主要疗效终点测量从基线到12周治疗结束或开始抢救治疗之前血清磷水平的变化。

Participants enrolled in the study were randomized in a 1:1 ratio to be treated with either AP306 or sevelamer carbonate. The study involved 11 investigational sites in China, led by Dr. Li Wang from Sichuan Provincial People's Hospital..

参加研究的参与者以1:1的比例随机分配，用AP306或碳酸司维拉姆治疗。这项研究涉及中国的11个研究地点，由四川省人民医院的王丽博士领导。。

About Alebund Pharmaceuticals

关于Alebund Pharmaceuticals

Alebund is a biopharmaceutical company jointly incubated by a group of industry leaders in the field of nephrology in Shanghai in 2018. Alebund focuses on the discovery and development of novel therapies primarily for kidney diseases and their complications, as well as other chronic conditions. Alebund has built a diversified and balanced pipeline of drug candidates targeting a range of renal diseases, including chronic kidney disease (CKD)/dialysis complications, IgA nephropathy, diabetic kidney disease, and autosomal dominant polycystic kidney disease (ADPKD).

Alebund是一家生物制药公司，由一群肾脏病领域的行业领导者于2018年在上海共同孵化。Alebund专注于发现和开发主要针对肾脏疾病及其并发症以及其他慢性病的新型疗法。Alebund已经建立了针对一系列肾脏疾病的多样化和平衡的候选药物管道，包括慢性肾病（CKD）/透析并发症，IgA肾病，糖尿病肾病和常染色体显性多囊肾病（ADPKD）。

Alebund's pipeline comprises both small-molecule and biological assets, in which the most advanced program is undergoing a pivotal phase III study..

Alebund的管道包括小分子和生物资产，其中最先进的项目正在进行关键的III期研究。。

About AP306

关于AP306

AP306 (EOS789)  is an oral inhibitor of phosphate transporters, NaPi-IIb, PiT-1, PiT-2, which was discovered by Chugai Pharmaceutical Co., Ltd.. Under the option and license agreement between Alebund and Chugai in 2021, Alebund conducted the phase II study with data reported in this release. Alebund has fully executed the global rights option and now owns the global development and commercialization rights for AP306. .

AP306（EOS789）是一种磷酸盐转运蛋白NaPi IIb，PiT-1，PiT-2的口服抑制剂，由Chugai Pharmaceutical Co.，Ltd.发现。根据Alebund和Chugai于2021年签订的期权和许可协议，Alebund进行了II期研究，数据见本次发布。Alebund已全面执行全球权利期权，目前拥有AP306的全球开发和商业化权利。

SOURCE Alebund Pharmaceuticals

来源Alebund Pharmaceuticals