Spring Bank Discontinues Development of Inarigivir for the Treatment of HBV
Continuing to focus on immuno-oncology & inflammation, including IV STING agonist clinical program, oral STING antagonist platform and STING agonist ADCs
Adjusting cost structure to fund operations into late 2022
HOPKINTON, Mass., Jan. 29, 2020 (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 that it has discontinued development of inarigivir soproxil, which was in Phase 2 development for the treatment of chronic hepatitis B virus (HBV). This decision was made in the interest of patient safety based on the occurrence of unexpected serious adverse events, including one patient death, in Spring Bank’s Phase 2b CATALYST trial.
“We are deeply saddened by the death of a patient in our CATALYST 2 trial. Because we are guided by an overriding interest in protecting patients, we have made the difficult decision to discontinue the further development of inarigivir for the treatment of HBV at Spring Bank,” said Martin Driscoll, President and CEO of Spring Bank. “We will continue to work in close collaboration with external experts and our clinical study investigators to provide the care necessary for all study patients and will continue to conduct a series of investigative actions to better understand the unexpected serious adverse events observed in our Phase 2b program.”
Spring Bank will not pursue further research and development efforts in HBV but will continue to focus on new treatments for diseases with high unmet needs in the therapeutic fields of immuno-oncology and inflammation. These efforts will primarily include the advancement of the lead product candidate from the company’s novel STING agonist platform, the intravenously (IV)-administered SB 11285, which is currently in a Phase 1a/1b trial.
“We will devote our resources to advancing multiple programs in our STING product portfolio, including our SB 11285 IV STING agonist clinical program in oncology, our STING antagonist compounds for inflammatory diseases, and our STING agonist ADC program,” continued Mr. Driscoll. “By the end of 2020, we plan to generate sufficient data from our Phase 1a/1b IV STING agonist program to enable advancement into a Phase 2 clinical trial, initiate IND-enabling activities for an orally-available STING antagonist and progress our pipeline of STING agonist ADCs.”
In accordance with the decision to discontinue the further development of inarigivir and all HBV drug development, Spring Bank will not invest further resources towards the company’s chimeric oligonucleotide antisense (CASO) program for HBV, and has initiated discussions with external parties for licensing of this program. As a result of the elimination of costs related to its HBV program, the company believes that its cash position of $54.5 million as of December 31, 2019 (unaudited) will fund the company’s new operating plan into late 2022.作者: StephenW 时间: 2020-1-30 05:16
麻萨诸塞州霍普金顿，2020年1月29日（全球新闻）-Spring Bank Pharmaceuticals，Inc.（纳斯达克股票代码：SBPH）是一家临床阶段的生物制药公司，目前正在开发用于治疗病毒感染，炎性疾病和某些癌症的新型疗法宣布已中止inarigivir soproxil的研发，后者处于2期开发中，用于治疗慢性乙型肝炎病毒（HBV）。此决定是出于患者安全的考虑，是基于Spring Bank 2b CATALYST期试验中意外的严重不良事件（包括一名患者死亡）的发生。
“在CATALYST 2试验中，一名患者的死亡使我们深感悲痛。由于我们出于保护患者的压倒一切利益的指导，我们做出了艰难的决定，决定停止在春天银行中停止使用inarigivir进一步治疗HBV ，“ Spring Bank总裁兼首席执行官Martin Driscoll说。”我们将继续与外部专家和临床研究调查人员密切合作，为所有研究患者提供必要的护理，并将继续采取一系列调查措施，以期更好地了解我们在2b期计划中观察到的意外严重不良事件。”
Driscoll先生继续说：“我们将投入资源来推进STING产品组合中的多个计划，包括我们的SB 11285 IV STING激动剂临床肿瘤计划，我们的STING炎性拮抗剂化合物以及STING激动剂ADC计划。” “到2020年底，我们计划从我们的1a / 1b IV STING激动剂计划中获得足够的数据，以使其能够进入2期临床试验，为口服STING拮抗剂启动IND激活活动，并改善我们的STING激动剂ADC。”