2022年11月11日

圣地亚哥,加利福尼亚,美国圣地亚哥,11月11日,2022(全球通讯社)——Biosplice疗法,Inc . (“Biosplice”),临床分期生物科技公司开创性first-in-class疗法基于小分子抑制CLK / DYRK激酶,今天宣布了从三个3期临床试验,OA-07, OA-10和OA-11膝关节OA的候选药物,lorecivivint。近期Biosplice数据,特别是在OA-07长期疗效试验,证明这两个症状和结构对治疗膝骨关节炎患者的关节损伤早期,定义为KL2和早期KL3病人,这代表估计膝OA人口的70%。OA-11结论后,12个月的研究中,完成参与者能够参加额外的3期临床试验,OA-07,与多个注射作为长期的扩展研究。OA-07第一年的研究期间,病人和调查人员仍然蒙蔽,患者接受注射卤在年度基础上,允许Biosplice捕捉repeat-injection和长期安全性和有效性数据。这些数据显示临床上显著改善内侧关节空间宽度相对于安慰剂,与0.13和0.20毫米的效果总体KL2和早期KL2患者,分别。此外,OA-07数据证明显著改善WOMAC疼痛和疼痛评分量表的强劲趋势(每日疼痛分数)以及WOMAC函数在所有科目。强大的功效在这个OA-07研究观察,随着OA-10试验的数据,帮助试验设计的基础Biosplice下一阶段3的审判,OA-21,如下所述。在两个3期临床试验之前,OA-10 OA-11, lorecivivint,演示了在早期临床疗效,减少结构受损的患者,尽管这些试验未能达到统计学意义的首要端点疼痛评分量表(每日疼痛分数)在第12周的所有科目。广泛的分析确定了两个潜在的混杂因素:参与者OA-10和OA-11结构最先进的疾病在计划日期和适当的分离可能抑制了安慰剂mobility-limiting COVID封锁协议,COVID大流行期间进行了试验。干扰大流行的活动水平和膝OA患者疼痛优点已经广泛reported1。 Consistent with observations of OA-07 data noted above, the six-month long OA-10 study demonstrated that lorecivivint outperformed placebo in the KL2 and early-stage KL3 patients (i.e., less structurally damaged patients), a key subgroup that represents the majority of the knee OA patient population. This subgroup showed consistent benefit with lorecivivint over placebo in multiple measurement time periods and metrics, such as pain NRS, WOMAC pain, WOMAC function and patient global assessment of disease activity in the OA-10 study. Consistent with the clinical program to date, lorecivivint continued to appear safe and well-tolerated in the recently completed studies, with no safety signals with repeat injections. “Healthcare professionals need an approach for treating knee osteoarthritis that can provide durable pain relief, improve functionality, and be safely utilized over a long period of time,” said Biosplice Chief Medical Officer, Yusuf Yazici, MD. “Biosplice aims to provide physicians a knee osteoarthritis treatment that does not compromise between efficacy and safety. Our local, intra-articular injection hopes to provide a safe, effective and much-needed structure-modifying treatment option to physicians and patients alike. Our data to date suggest that earlier, less structurally damaged patients provide the ideal target population to study in our next Phase 3 trial, which we expect will further support the beneficial effects of lorecivivint in this very important patient population.” Biosplice conducted a meeting with the FDA in Q3 2022, in which its next phase 3 study for lorecivivint was discussed. Designated OA-21, this next phase 3 trial is designed as a 16-week study with a primary endpoint of Pain NRS at 12 weeks and enrollment is expected to begin in Q4 2022. This study will further evaluate the impact of lorecivivint on knee osteoarthritis pain and function and has been modeled after the early, less structurally damaged patient population that has shown consistent responses across Biosplice’s Phase 2 and Phase 3 clinical trials. Biosplice will be presenting data in three poster presentations and one oral presentation at the 2022 ACR Annual Meeting as outlined below. Oral presentation details: