春季银行宣布了第二阶段试验的第一批中期结果，该试验评

StephenW

Spring Bank Announces Interim Top-Line Results from the First Cohort of the Phase 2 Trial Evaluating Low-Dose Inarigivir Plus Vemlidy® in Chronic Hepatitis B Patients

Published: Oct 17, 2019

HOPKINTON, Mass., Oct. 17, 2019 (GLOBE NEWSWIRE) -- Spring Bank Pharmaceuticals, Inc., (Nasdaq: SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, inflammatory diseases and certain cancers, today announced interim top-line results at 12 weeks from the first cohort of the ongoing Phase 2 trial evaluating the safety, efficacy and pharmacodynamics of escalating doses (50mg, 200mg and 400mg) of the investigational compound inarigivir co-administered with Gilead Sciences, Inc.’ Vemlidy® (tenofovir alafenamide 25mg) for the treatment of chronic hepatitis B virus (HBV) infection. This is the first data from a clinical trial examining the co-administration of inarigivir with a nucleoside analog (NUC) in chronic HBV patients.

“We are impressed by the top-line results from the first cohort of the clinical trial examining the co-administration of the low dose of inarigivir 50mg and the nucleoside analog, Vemlidy®,” said Martin Driscoll, chief executive officer of Spring Bank. “We are very encouraged that these preliminary results suggest the addition of a low dose of inarigivir to a NUC therapy in chronic HBV patients could enhance the size of the HBsAg responder population as compared to the experience with the 50mg monotherapy dose in our completed Phase 2 ACHIEVE dose escalation trial. We look forward to the data from the higher dose cohorts of this trial and our ongoing CATALYST Phase 2b studies evaluating longer durations of treatment with inarigivir monotherapy and co-administered with a NUC that could further expand the chronic HBV responder population with the goal to significantly elevate functional cure rates for HBV patients.”

In this Phase 2 trial, 30 patients with HBV infection received low-dose inarigivir 50mg plus Vemlidy for 12 weeks and 12 patients with HBV infection received Vemlidy alone for 12 weeks. Both arms will continue to receive Vemlidy alone for an additional 36 weeks. Interim top-line results from the first cohort indicate that, at week 12, 7 of the 30 patients in the inarigivir 50mg plus Vemlidy arm were HBsAg responders and met the primary efficacy study endpoint of having greater than or equal to 0.5 log₁₀ IU/mL reduction in HBsAg from baseline. When excluding patients showing signs of an ALT flare prior to entering the study, 5 of the remaining 28 patients in this arm were HBsAg responders at week 12. In the inarigivir 50mg monotherapy cohort of the completed Spring Bank Phase 2 ACHIEVE trial, only 1 of 14 patients was a HBsAg responder at week 12.

In the Vemlidy arm of this Phase 2 trial, 3 of the 12 patients were HBsAg responders. When excluding patients showing signs of an ALT flare prior to entering the study, only 1 of the remaining 10 patients in this arm was a HBsAg responder at week 12.

The co-administration of inarigivir 50mg and Vemlidy was generally safe and well tolerated with no serious adverse events observed over the 12-week treatment period. Treatment-emergent adverse events ranged from mild to moderate in severity.

Further analysis of the inarigivir 50mg plus Vemlidy cohort and evaluation of the safety, efficacy and pharmacodynamics of escalating doses of inarigivir (200mg and 400mg) co-administered with Vemlidy in HBV patients are ongoing. Interim top-line results from the remaining cohorts of the trial are expected in 2020.

StephenW

春季银行宣布了第二阶段试验的第一批中期结果，该试验评估了慢性乙型肝炎患者的低剂量Inarigivir PlusVemlidy®

发布时间：2019年10月17日

马萨诸塞州霍普金顿，2019年10月17日（环球新闻）-Spring Bank Pharmaceuticals，Inc.（纳斯达克代码：SBPH）是一家临床阶段的生物制药公司，致力于开发治​​疗病毒感染，炎性疾病和某些癌症的新型疗法今天宣布的正在进行中的2期临床试验的第一个队列起第12周的中期最佳结果是，与吉利德科学公司共同给药的递增剂量（50mg，200mg和400mg）的研究用化合物inarigivir的安全性，疗效和药效学。” Vemlidy®（替诺福韦alafenamide 25mg）用于治疗慢性乙型肝炎病毒（HBV）感染。这是来自临床试验的第一个数据，该试验研究了inarigivir与核苷类似物（NUC）在慢性HBV患者中的共同给药。

Spring Bank首席执行官Martin Driscoll表示：“第一批临床试验的最高结果给我们留下了深刻的印象，该试验研究了低剂量的inarigivir 50mg与核苷类似物Vemlidy®的共同给药。” “我们感到非常鼓舞的是，这些初步结果表明，与我们完成的第2阶段50mg单一疗法的经验相比，慢性HBV患者在NUC治疗中加入低剂量的inarigivir可以增加HBsAg反应人群的规模。 ACHIEVE剂量递增试验。我们期待该试验的更高剂量组的数据以及我们正在进行的CATALYST 2b期研究评估使用inarigivir单一疗法并与NUC联合使用可以延长慢性HBV应答人群的更长疗程目的是显着提高HBV患者的功能治愈率。”

在该2期试验中，30例HBV感染患者接受了低剂量的inarigivir 50mg加Vemlidy治疗12周，而12例HBV感染患者仅接受Vemlidy治疗12周。双方将继续接受单独的Vemlidy治疗，持续36周。第一组的中期顶线结果表明，在inarigivir 50mg加Vemlidy组的30位患者中，第12周有7位是HBsAg应答者，并且达到了主要疗效研究终点，即大于或等于0.5 log10 IU / mL与基线相比，HBsAg降低。如果排除进入研究前出现ALT耀斑迹象的患者，则该组中其余28位患者中的5位在第12周时为HBsAg应答者。在完成的Spring Bank Phase 2 ACHIEVE试验的inarigivir 50mg单药队列中，仅1位患者第12周有14例患者为HBsAg应答者。

在该2期试验的Vemlidy组中，12名患者中有3名是HBsAg应答者。如果排除在进入研究之前出现ALT耀斑迹象的患者，则该组中其余10位患者中只有1位在第12周出现HBsAg反应。

依那吉韦50mg和Vemlidy共同给药通常是安全的，并且耐受性良好，在12周的治疗期内未观察到严重的不良事件。紧急治疗不良事件的严重程度从轻度到中度不等。

正在进行进一步分析inarigivir 50mg加Vemlidy队列的研究，以及对逐步增加剂量的inarigivir（200mg和400mg）与Vemlidy联合应用在HBV患者中的安全性，疗效和药效学的评估。预计其余试验的中期最高收入将在2020年公布。

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