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1、Aerpio Therapeutics Reports Peer-Reviewed Publication of Positive Clinical Results from thePhase 2a Study of Lead Candidate, AKB-9778, in Diabetic Macular Edema (DME): The TIME-2TrialAerpio医疗公司宣布AKB-9778治疗糖尿病性黄斑水肿(DME)的Ph2a期TIME-2临床试验的数据结果发表在眼科杂志上June 13, 2016 11:20 AM Eastern Daylight TimeCINCINNAT
2、I-(BUSINESSWIRE)-Aerpio Therapeutics, Inc., a biopharmaceutical company focused on advancing first-in-class treatments for the eye, today announced that clinical data from the companys Phase 2a study of its lead candidate, AKB-9778, for the treatment of patients with DME, have been published in an a
3、rticle titled “Enhanced Benefit in Diabetic Macular Edema from AKB-9778 Tie2 Activation Combined with Vascular Endothelial Growth Factor Suppression,” which is currently available online in the peer-reviewed journal Ophthalmology. As previously announced in an oral presentation at the most recent Am
4、erican Academy of Ophthalmology Annual Meeting (November, 2015), the combination of AKB-9778 (dosed at 15 mg BID subcutaneously) and Lucentis (ranibizumabinjesction dosed at 0.3 mg intravitreally) provided a clinically significant benefit in reduction of macular edema, as measured by central subfiel
5、d thickness (CST), compared to Lucentis alone at month 2 (p=0.02) and at end of treatment at month 3 (p=0.008). In association with the improvement in CST, the combination therapy showed a trend towards improved visual acuity (proportion of patients achieving improvement of at least 3 lines in visua
6、l acuity) when compared to Lucentis alone【. Aerpio 是 一家致力于开发眼部疾病治疗药物的生物制药公司， 今天宣布 AKB-9778 治疗 DME 患者的 Ph2a 期临床研究结果发表在眼科杂志上，文章题目 为“AKB-9778通过激活Tie2和抑制血管内皮生长因子对糖尿病性黄斑水肿有治疗益处” 如先前在眼科年度会议上口头报道的最新进展一样，联合AKB-9778 (皮下注射15mg BID 剂量)和Lucentis (ranibizumab玻璃体腔注射0.3mg)用药，治疗2个月及3月后 vs.Lucentis单独用药对降低黄斑水肿有临床意义的益
7、处，黄斑水肿程度用中央子域厚度(CST)进行测量。在改善CST方面，相比Lucentis单药，联合用药能提高视敏度。】Further, data from the TIME-2 study demonstrated the ability of systemically administered AKB-9778 monotherapy to improve underlying diabetic retinopathy by 2 or more steps in both study and fellow eyes without the need for intraocular injec
8、tions . In regard to the safety profile, there were no clinically significant differences in the percentage of patients that experienced ocular or non-ocular adverse events across the three study arms.【TIME-2 研究的数据表明 AKB-9778 单药治疗能改善潜在的糖尿病视网膜病变。在安全性方面，在三个研究臂中，眼 部和非眼部的不良事件在百分比上没有临床显著差异。】“The TIME-2 s
9、tudy has provided broad mechanistic support for the potential use of AKB-9778 in promoting the stabilization of vascular beds,” commented Dr. Steve Pakola, Aerpios Chief Medical Officer. Dr. Pakola continued, “Based on these promising results, we are continuing our preparations to advance AKB-9778 i
10、nto late stage clinical studies in DR and DME. As previously reported, we anticipate targeting additional ophthalmic indications as well, including wet age-related macular degeneration (wAMD).【公司 CMO 说：“TIME-2 研究为 AKB-9778 能促 进血管床的稳定提供了多方的机制支持。基于这些可喜的结果，将继续推进AKB-9778进入 到治疗DR和DME的晚期临床研究中。如前所述，将针对其他眼科
11、适应症进行探索，包括 湿性年龄相关性黄斑变性(wAMD)。”】About the TIME-2 StudyTIME-2 was a Phase 2a, randomized, double-masked, placebo-controlled, proof-of-concept study in DR patients with DME. The TIME-2 study evaluated 144 patients randomized equally (1:1:1) to AKB-9778 as monotherapy or in combination with Lucentis com
12、pared with Lucentis alone for a treatment period of 3 months, followed by a 2-month observation period. The studys primary endpoint measure was mean change from baseline in CST at 3 months. Secondary endpoint measures included visual acuity and safety outcomes. 【TIME-2 是在患有 DME 的 DR 患者中的一项Ph2a期、随机、双
13、盲、安慰剂对照、概念性证明试验oTIME-2研究将随机分 配 144 名患者(1:1:1)到 AKB-9778 单药、AKB-9778+Lucentis联合用药、Lucentis单药 三个研究组中，为期3个月，随后有2个月的观察期。研究的主要终点是测量CST的平均 改变水平。次要终点是视敏度的改善和安全性质。About AKB-9778AKB-9778 is a first-in-class small molecule that inhibits the enzyme, vascular endothelial protein tyrosine phosphatase (VE-PTP), w
14、hich acts as a negative regulator of the Tie2 receptor. By inhibiting this negative regulator, Tie2 signaling is restored, overcoming the effects of vascular destabilization. Aerpio is initially focusing development of AKB-9778 in DR and DME, with potential for development in other vascular retinal disorders, including wAMD.【AKB-9778 是首 创小分子血管内皮细胞蛋白酪氨酸磷酸酶(VE-PTP)抑制剂，VE-PTP是Tie2受体的负调 节因子。通过抑制VE-PTP，能恢复Tie2信号，从而阻断血管不稳定造成的影响。Aerpio 公司初期开发AKB-9778治疗DR和DME，此外，在其他其他血管性视网膜疾病中包括 wAMD也有治疗潜能。
