Ridinilazole

03月09日的《热心肠日报》，我们解读了 15 篇文献，关注：菌群疗法，生物材料，乳糜泻，IBS，低FODMAP饮食，内脏痛，肠脑互作障碍，临床试验，儿童功能性便秘，艰难梭菌感染，Epitomee，雀巢，Empros Pharma，复宏汉霖，食物不耐受，合生元，东北农业大学。 该篇日报由R·AI辅助创作生成，人工审核校对。 AGA指南：在特定胃肠疾病中使用基于粪便菌群的疗法 Gastroenterology——[29.4] ① 美国胃肠病学会（AGA）发布最新临床实践指南，该指南采用GRADE框架制定，为在成人中使用基于粪便微生物群的疗法（如传统粪菌移植和相关活体生物药）提供指导建议；② 对于免疫功能正常的复发性艰难梭菌感染成人患者，在完成标准抗生素治疗后，AGA建议选择性使用基于粪便微生物群的疗法以预防复发；③ 对于轻度或中度免疫功能受损的复发性艰难梭菌感染成人患者，AGA建议选择性使用传统粪菌移植；④ 对于免疫功能严重受损的成人，AGA建议不要使用任何基于粪便微生物群的疗法去预防复发性艰难梭菌感染；⑤ 对于对标准抗生素治疗无效的严重或暴发性艰难梭菌感染住院成人，AGA建议选择性使用常规粪菌群移植；⑥ AGA建议不要将传统的粪菌移植用作治疗炎症性肠病或肠易激综合征，除非在临床试验中。 【原文信息】 AGA Clinical Practice Guideline on Fecal Microbiota-Based Therapies for Select Gastrointestinal Diseases 2024-03-01 , doi: 10.1053/j.gastro.2024.01.008 国内外合作Science：新型生物材料助力胃肠道术后监测 Science——[56.9] ① 胃肠道手术后的吻合口漏可危害患者健康甚至生命，其早期检测仍是挑战，清华大学王禾翎与国外团队合作的这项研究开发了一种生物可吸收、形状自适应的材料结构（BioSUM），以实现对深部组织稳态的常规超声监测；② BioSUM由分布在pH响应性水凝胶中的生物可吸收的微小金属盘组成，可通过手术植入或注射方式置于监测部位，金属盘间距的变化可反映该部位的pH变化，可在超声图像中测量；③ 在大鼠和猪模型中，BioSUM成功检测到胃、小肠和胰腺的泄漏，表现出对pH变化的敏感性和特异性；④ BioSUM在体内能自然分解吸收，无需二次手术取出，有望用于术后胃肠道吻合口漏的早期监测。 【原文信息】 Bioresorbable shape-adaptive structures for ultrasonic monitoring of deep-tissue homeostasis 2024-03-07 , doi: 10.1126/science.adk9880 Nature Reviews：乳糜泻治疗新希望——耐受诱导疗法（综述） Nature Reviews Gastroenterology and Hepatology——[65.1] ① 本综述总结了耐受性治疗在乳糜泻中的机制、进展和未来方向，指出针对麸质特异性CD4+ T细胞的治疗策略具有潜力成为乳糜泻的独立治疗方法；② 麸质特异性CD4+ T细胞驱动乳糜泻中异常自身免疫反应，导致肠病和自身抗体的形成，目前唯一的治疗方法是终身避免饮食中的麸质；③ 针对麸质特异性CD4+ T细胞已设计并探索了多种耐受诱导疗法的策略，目前正在进行临床前、I期或II期临床试验中；④ 耐受诱导疗法中涉及的分子机制尚未完全阐明，以及如何最佳地衡量乳糜泻治疗的有效性仍在讨论之中。 【原文信息】 Tolerance-inducing therapies in coeliac disease — mechanisms, progress and future directions 2024-02-09 , doi: 10.1038/s41575-024-00895-3 找出食物触发因素：盲测FODMAP成分对肠易激综合征的影响 Gastroenterology——[29.4] ① 通过盲法随机重新引入阶段，旨在验证低可发酵寡糖、双糖、单糖和多元醇（FODMAP）饮食在缓解IBS症状方面的有效性，并客观识别其触发因素；② 在117名IBS患者中，经6周低FODMAP饮食干预后，IBS症状严重程度显著改善，80%的参与者对饮食反应良好；③ 在随后9周盲法随机重新引入阶段中，85%患者出现了由平均2.5种FODMAPs引发的症状复发，其中以果糖聚糖和甘露醇为最常见触发因素；④ 该研究为IBS患者提供了一种客观识别个体FODMAP触发因素的方法，有助于个性化调整饮食以改善生活质量。 【原文信息】 Efficacy and findings of a blinded randomized reintroduction phase for the low FODMAP diet in Irritable Bowel Syndrome 2024-02-22 , doi: 10.1053/j.gastro.2024.02.008 难以言喻之痛：慢性内脏痛的外周机制与临床治疗进展（综述） Gastroenterology——[29.4] ① 慢性内脏痛是胃肠道疾病患者就医最常见的原因，如炎症性肠病IBD和脑肠轴紊乱患者，该症状多伴随着焦虑、抑郁、社交障碍，导致生活质量严重下降，直接、间接地导致医疗成本大幅增加；② 这篇综述对慢性内脏痛的外周信号、具体的临床前机制以及相应疗法的研究进展进行了总结；③ 文章深入探讨了多种具体机制及相关疗法，包括肠细胞受体鸟苷酸环化酶-C（GC-C）在液体分泌、屏障功能和伤害感受中的作用；④ 以及阿片类药物信号与G蛋白偶联受体的互作、肠道微生物、组胺、TRPV1（非选择性配体门控阳离子通道）、血清素和大麻素代谢以及氨基丁酸与慢性内脏疼痛的关系；⑤ 指出后续的研究应该进一步鉴别微生物与宿主信号的区别，聚焦机制的挖掘以及不同机制对伤害感受受体的调节的比重。 【原文信息】 CHRONIC VISCERAL PAIN: NEW PERIPHERAL MECHANISTIC INSIGHTS AND RESULTING TREATMENTS 2024-02-05 , doi: 10.1053/j.gastro.2024.01.045 不同肠脑轴障碍性疾病诊断中患者报告结局的应用（综述） Gastroenterology——[29.4] ① 本综述全面总结了患者报告结局（PROs）在不同肠脑轴障碍性疾病（DGBIs）中诊断和治疗评估中的应用；② 汇总了功能性消化不良、肠易激综合征和慢性便秘等常见DGBIs的现有PROs的内容、临床实践和研究中的验证水平；③ 进一步强调了对这些PROs的监管方法，并指出了未来发展方向和对其他DGBIs PROs进一步研究的需求；④ 综上，PROs是评估DGBIs症状模式和严重程度的关键工具之一，对于诊断和跟踪治疗评估至关重要。 【原文信息】 Patient reported outcomes in Disorders of Gut-Brain Interaction 2024-02-01 , doi: 10.1053/j.gastro.2023.11.307 肠易激综合征与较低的死亡风险相关 American Journal of Gastroenterology——[9.8] ① 这项研究探索了肠易激综合征（IBS）与全因和特定原因死亡之间的关联；② 纳入UK Biobank的502369名参与者，其中25697名（5.1%）参与者在基线时有过IBS病史，中位随访13.7年内共发生44499例死亡；③ 有IBS病史与5年内的全因和所有癌症死亡风险呈强负相关，这种关联在随访过程中有所减弱，但即使在随访10年后，这种关联仍然是负相关的；④ 在某些随访时间范畴中，患有IBS的个体患者患乳腺癌、前列腺癌和结直肠癌的死亡风险降低；⑤ 这一发现提示了IBS与死亡率之间的复杂关系，需要进一步研究特定因素，如生活方式和医疗保健获取是否能解释这种负相关关系。 【原文信息】 The Time-Dependent Association between Irritable Bowel Syndrome and All-cause and Cause-specific Mortality: A Prospective Cohort Study within the UK Biobank 2024-01-26 , doi: 10.14309/ajg.0000000000002675 替纳帕诺对肠易激综合征患者腹部症状的改善作用 American Journal of Gastroenterology——[9.8] ① 纳入1372名便秘型肠易激综合征（IBS-C）患者，684名接受替纳帕诺（Tenapanor），688名接受安慰剂干预，评估替纳帕诺对IBS-C患者腹部症状的疗效；② 替纳帕诺组在12周内腹部症状的改善（最小二乘均值变化为-2.66）明显优于安慰剂组（-2.09）；③ 替纳帕诺r组6/12周和9/12周的腹部症状反应率（44.4%、30.6%）均显著高于安慰剂组（32.4%、20.5%）；④ 每周完全自主排便状态与每周腹部症状反应状态呈显著关联，且一周内有更多患者实现腹部症状减少；⑤ 综上，替纳帕诺显著减轻IBS-C患者的疼痛、不适和胀气等腹部症状。 【原文信息】 Abdominal Symptom Improvement During Clinical Trials of Tenapanor in Patients With Irritable Bowel Syndrome With Constipation: A Post Hoc Analysis 2024-01-31 , doi: 10.14309/ajg.0000000000002685 Lancet子刊：利那洛肽可安全有效地治疗儿童功能性便秘 Lancet Gastroenterology & Hepatology——[35.7] ① 这项3期临床试验评估了利那洛肽（linaclodide）在6-17岁功能性便秘患儿中的疗效和安全性，结果显示利那洛肽显著增加了自发排便频率，并改善了粪便硬度，且耐受性良好；② 330名功能性便秘患儿随机均分为两组，每日口服利那洛肽或安慰剂，干预12周；③ 相比于安慰剂，利那洛肽显著增加自发排便频率（每周增加1.17次），并显著改善粪便硬度；④ 利那洛肽组最常见的治疗相关不良事件是腹泻，发生率4%；⑤ 利那洛肽组发生一例严重不良事件（严重腹泻），在治疗后解决，无死亡病例发生；⑥ 利那洛肽对功能性便秘患儿有效且耐受良好，并已被FDA批准用于此适应症。 【原文信息】 Efficacy and safety of linaclotide in treating functional constipation in paediatric patients: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial 2024-01-08 , doi: 10.1016/S2468-1253(23)00398-9 新型抗生素Ridinilazole治疗艰难梭菌感染 Clinical Infectious Diseases——[11.8] ① 本研究通过比较利地尼唑（Ridinilazole）与万古霉素治疗艰难梭菌感染（CDI）的效果，揭示了利地尼唑在减少复发性CDI（rCDI）和保护肠道菌群多样性方面的优势；② 利地尼唑与万古霉素的持续临床反应率分别为73%和70.7%；③ 但利地尼唑在减少rCDI方面表现更佳，相比之下降低了53%(8.1% vs 17.3%)；④ 利地尼唑可保持菌群多样性，增加次级胆汁酸（SBAs）的相对丰度，且不增加耐药基因组；⑤ 相反，万古霉素加剧CDI相关的菌群失调，减少SBAs，增加变形菌门丰度（约3.5倍），且增加耐药基因组；⑥ 综上，利地尼唑治疗CDI可使肠道菌群健康更早恢复。 【原文信息】 A Randomized, Double-Blind, Phase 3 Safety and Efficacy Study of Ridinilazole Versus Vancomycin for Treatment of Clostridioides difficile Infection: Clinical Outcomes With Microbiome and Metabolome Correlates of Response 2024-02-02 , doi: 10.1093/cid/ciad792 Epitomee和雀巢合作开发的减肥胶囊申报上市 ① 3月6日，Epitomee公司宣布已通过510（k）途径向FDA递交减肥胶囊的批准申请，此前该产品已在欧盟获得批准并带有CE标志；② 该减肥胶囊是一种模仿固体食物的变形胶囊，可激活大脑和胃中调节食物摄入的关键途径，具有良好的安全性和耐受性，适用于超重和轻度肥胖人群；③ 其关键临床RESET研究显示，大多数患者（56%）在使用减肥胶囊后体重减轻了5%或更多，且与对照组相比，减重效果更佳；④ 2020年8月，Epitomee与雀巢健康科学达成战略合作，雀巢拥有减肥胶囊的全球独家商业化权益。 【原文信息】 雀巢合作开发的减肥胶囊申报上市 2024-03-07 , 医药魔方Info Empros Pharma公布EMP16 2b期临床积极顶线结果 ① 3月6日，Empros Pharma公司公布了在研口服小分子减肥疗法EMP16 2b期临床的积极顶线结果，平均体重减轻8%；② EMP16是一种基于奥利司他和阿卡波糖两种已获批化合物的组合配方，旨在减少游离脂肪酸和葡萄糖的吸收；③ EMP16独有配方可以在胃肠道系统产生局部效果，增强疗效的同时降低潜在的副作用；④ 其安全性和口服特征适合作为维持疗法，帮助肥胖患者维持体重或轻度超重人群减重；⑤ Empros Pharma计划启动两项3期临床试验，以进一步探究EMP16在伴有或不伴有2型糖尿病的肥胖或超重人群中的效果。 【原文信息】 速递 | 口服小分子减肥疗法2期临床结果积极，计划启动两项3期临床试验 2024-03-06 , 药明康德 复宏汉霖「汉曲优」在菲律宾和泰国获批 ① 近期，复宏汉霖自主开发的汉曲优（曲妥珠单抗生物类似药）在泰国和菲律宾获批上市，用于治疗HER2阳性的乳腺癌和胃癌；② 汉曲优已在全球超过40个国家和地区获批上市，包括新加坡、柬埔寨等东南亚国家；③ 曲妥珠单抗是治疗HER2阳性乳腺癌和胃癌的基石类药物，已被多个国家和组织的治疗指南推荐；④ 汉曲优的生产和质量控制环节遵循国际最高标准，生产基地及质量管理体系获得中欧双GMP认证。 【原文信息】 复宏汉霖自主开发和生产的汉曲优®在菲律宾、泰国获批 2024-03-07 , 复星 Mauna Kea Technologies与Metrodora开展食物不耐受患者护理合作 ① 3月6日，Mauna Kea Technologies与Metrodora Institute两家公司宣布，将在美国建立首个专注于诊断和治疗食物不耐受患者的医学中心；② 在美国，大约10～15%的成年人口患有肠易激综合症，该病症与食物不耐受有较大关联；③ Mauna Kea Technologies将在合作中提供Cellvizio Food Intolerance Test (C-FIT) 诊断方案，C-FIT可实时观察到患者进食后肠道屏障功能状况；④ Metrodora Institute将在合作中负责患者的护理诊断和医师训练工作，以使该护理方案能惠及更广大人群。 【原文信息】 Mauna Kea Technologies Partners with Metrodora to Create First U.S. Center of Excellence for the Use of Cellvizio® to Identify and Treat Food Intolerance in Adults 2024-03-06 , businesswire 「合生元」携手「东北农业大学」成立乳源创新研究中心 ① 3月5日，合生元携手东北农业大学签约成立乳源创新研究中心，旨在合作开展诺曼底牛乳检测工作及乳品创新研究；② 该合作致力于深挖诺曼底熊猫牛的乳源差异化优势，帮助消费者全面了解天然高品质营养素，并为消费者的选购提供更可靠的科学支持；③ 产学研合作模式旨在加速乳源科研成果产出，推动资源共享和互惠共赢；④ 通过此次合作，合生元将进一步优化奶源建设，持续深入科学研究，引领行业品质升级。 【原文信息】 合生元携手东北农业大学成立乳源创新研究中心，致力打造科研协同夯实品质基础 2024-03-06 , 健合集团 感谢本期日报的审核者：九卿臣，mildbreeze，RZN，好雨，Zhonghua，章台柳，圆圈儿，aluba，lxx，Richard 点击阅读过去10天的日报： 0308 | Lancet综述：炎症性肠病患者的孕期指南 0307 | 今日Nature：白色念珠菌"定居"肠道的秘诀 0306 | 肠道菌群如何代谢胆汁酸？17页高分综述一文读懂 0305 | Cell子刊：肠炎如何影响肠菌DNA"开关"？ 0304 | 《自然·医学》新发现：菌株水平的肠菌特征，为跨癌症免疫治疗提供助力 0303 | 7天不吃饭，人体发生哪些变化？Nature子刊研究带来新知 0302 | 可吞咽设备：诊疗肠道疾病的新利器 0301 | 2月，最值得看的35篇肠道学术文献&产业要闻！ 0229 | 今日Nature：早期大肠癌如何躲过免疫系统？幕后黑手被锁定 0228 | 国内团队Nature子刊：抗性淀粉重塑菌群助减肥

Akeso Inc. to out-license to Summit Therapeutics exclusive rights to ivonescimab (PD-1/VEGF) for the development and commercialization in the United States, Canada, Europe, and Japan. Akeso Inc. will retain development and commercialization rights for the rest of the world including China. Akeso Inc. to receive US$500 million upfront payment and the total potential deal value is up to US$5 billion including regulatory and commercial milestone payments. And Akeso will also receive low double-digit percentage of royalties on net product sales of ivonescimab . In addition, Dr. Michelle Xia will be appointed to the board of directors of Summit Therapeutics. Agreement provides an expedited and winning pathway for ivonescimab's global development by partnering with the world-class Summit Therapeutics team, who has the track record of successfully bringing over a dozen indications to market for the first-in-class blockbuster drug IMBRUVICA® (ibrutinib). Agreement demonstrates the significant global commercial potential of ivonescimab and provide immediate cash proceeds to Akeso Inc. to further expedite its drug development and other strategic initiatives. MENLO PARK, Calif. and GRAND CAYMAN, Cayman Islands, Dec. 6, 2022 /PRNewswire/ -- Akeso Biopharma Inc. (HKEX Code: 9926.HK, "Akeso", or the "Company"), a commercial-stage biopharmaceutical company focused on developing and commercializing first-in-class and best-in-class innovative medicines globally, today announced a collaboration and license agreement (the "Agreement") with Summit Therapeutics Inc. (NASDAQ: SMMT) (the "Summit"), to out-license its breakthrough bispecific antibody, ivonescimab (PD-1/VEGF, AK112) for development and commercialization in the United States, Canada, Europe, and Japan (the "License Territories"). In addition, the Company will co-brand the product in the License Territories. Ivonescimab, known as AK112 in China and Australia and also as SMT112 in the License Territories, is a novel, potential first-in-class bispecific antibody independently developed by the Company. Ivonescimab combines the power of immunotherapy via a blockade of PD-1 with the anti-angiogenesis benefits of an anti-VEGF into a single molecule. It is our belief that the novel design has the potential to reduce side effects and safety concerns. Ivonescimab is believed to be the PD-1 / VEGF bispecific antibody that is most advanced in the clinic: there are no known PD-1-based bispecific antibodies approved by the US Food and Drug Administration ("FDA") or the European Medicines Agency ("EMA"). Currently, Akeso is conducting a phase III clinical trial of ivonescimab monotherapy versus pembrolizumab monotherapy as the first-line treatment for NSCLC patients with positive PD-L1 expression. In addition, a phase III clinical trial of Ivonescimab plus chemotherapy versus chemotherapy in EGFR mutated advanced non-squamous NSCLC that failed in prior EGFR-TKI therapy is ongoing. Ivonescimab has received breakthrough therapy designation status in China from the NMPA for three indications: the two aforementioned indications, as well as combined with docetaxel for the treatment of locally advanced or metastatic NSCLC patients who failed to prior PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy. As presented at ASCO 2022, ivonescimab treatment was associated with an overall response rate (ORR) in a Phase II study in patients with NSCLC who have failed EGFR-TKI's of 68.4% and a median Progression-Free Survival (mPFS) time period of 8.2 months when combined with combination chemotherapy (pemetrexed and carboplatin) as compared to historical mPFS of 4.3 months in patients treated with combination chemotherapy (pemetrexed and platinum-based chemotherapy) alone, the current standard of care. In a separate cohort, ivonescimab combined with docetaxel in patients who have failed PD-(L)1 and chemo therapies demonstrated a mPFS of 6.6 months as compared to a historical mPFS of 4.5 months with docetaxel alone, a current standard of care regimen for these patients. The study which similarly had patients receiving ivonescimab plus chemotherapy as their first line therapy for metastatic disease, was considered to have demonstrated a tolerable safety pro a low discontinuation rate for adverse events. "Ivonescimab has demonstrated the potential to deliver superior clinical benefit for patients." said Dr. Michelle Xia, co-founder, Chairwoman, CEO, and President of Akeso, "The Akeso team has been dedicated to the development of ivonescimab in the past 8 years and advanced the molecule to the clinical Phase III stage. The global value of ivonescimab awaits great work from a great team to realize. We are so pleased to partner with the world-class Summit team, who has the track record of successfully bringing over a dozen indications to market for the first-in-class blockbuster drug IMBRUVICA® (ibrutinib). Following intense and in-depth strategic, scientific, and operational discussion on ivonescimab between the Akeso and Summit teams in recent months, we are more confident than ever on a winning path for ivonescimab's global development. With this tremendous momentum, we look forward to the swift execution of clinical development and commercial plan in a global setting for ivonescimab." "The partnership between Summit and Akeso is a strategically compelling opportunity," stated Robert W. Duggan, Chairman and Chief Executive Officer of Summit. "It represents bringing together Akeso's extraordinary team, which has built an innovation engine capable of creating novel bispecific technologies, and the talented members of team Summit with their proven track record of success of global clinical development, regulatory approvals, and commercialization, particularly in oncology. We believe the potential exists for enormous creation through this partnership. We are extremely encouraged by ivonescimab and the potential for improving the quality and duration of patients' lives based on clinical data to support this point. Summit team is honored and enthusiastic to partner with Akeso. Our shared mission and vision are to create a significant difference for the betterment of patient healthcare outcomes around the world." "After reviewing a substantial number of opportunities, much of which was focused on potential treatments for solid tumors, we have found the ideal partnership with the potential to change the paradigm for treating patients facing difficult odds with devastating diagnoses," added Dr. Maky Zanganeh, Co-Chief Executive Officer, President, and a member of Summit's Board of Directors. "Ten years ago, metastatic lung cancer patients rarely survived for more than ten to twelve months from diagnosis. Today, survival can be measured in years. Our goal is to improve the quality of life of a patient facing immeasurable odds while extending the duration of that patient's life. Our focus is always on how we can improve the lives of patients. We sought patient-friendly medicinal therapies through our search to expand our pipeline portfolio, and we are proud to take this meaningful step towards accomplishing this goal. We have significant work to do, but we are steadfastly committed to bringing ivonescimab into the hands of patients who need it most. We are thrilled to reach this agreement with Michelle and the team at Akeso, and we are excited to make this vision a reality. I am proud of Summit team who have diligently worked these past few months to establish a strong bond with the team at Akeso, and I would like to thank the talented people of Team Akeso for spending so much quality time creating this meaningful partnership." Under the terms of the Agreement, Akeso will receive US$500 million upfront payment and the total potential deal value is up to US$5 billion including regulatory and commercial milestone payments. And Akeso will also receive low double-digit percentage of royalties on net product sales of ivonescimab. The Summit will receive the exclusive rights to develop and commercialize ivonescimab (SMT112) in the United States, Canada, Europe, and Japan. Akeso will retain development and commercialization rights for the rest of the world including China. In addition, Dr. Michelle Xia will be appointed as one member of the board of directors of Summit. The deal is subject to customary closing practices, including applicable waiting periods under the Hart-Scott-Rodino (HSR) Act. About Akeso Inc. Akeso (HKEX: 09926) is a commercial-stage biopharmaceutical company committed to the discovery, development, manufacturing, and commercialization of innovative medicines with high unmet medical needs worldwide. Founded in 2012, the company has established a comprehensive in-house drug development platform (ACE Platform) and know-how, including R&D, clinical development, CMC (Chemistry, Manufacturing, and Controls), and commercialization capabilities. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 30 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease, and other major therapeutic areas. 17 assets have entered clinical stage. Leveraging in-house developed bispecific platform technology ("Tetrabody technology"), the company has advanced four potential first-in-class bispecific antibody drugs into market or clinical development, including cadonilimab (PD-1/CTLA-4), ivonescimab (PD-1/VEGF), PD-1/LAG-3, and TIGIT/TGF-Beta bispecific antibodies. In June 2022, cadonilimab was approved by the NMPA and became the first commercialized PD-1 based bispecific drug globally. Another Akeso internally discovered and developed oncology product, penpulimab (a PD-1 antibody), was granted marketing approval in China in August 2021. Akeso is listed on the Main Board of the Stock Exchange of Hong Kong Limited. About Summit Therapeutics Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol 'SMMT'). We are headquartered in Menlo Park, California, and we have additional offices in Oxford, UK and Cambridge, UK. For more information, please visit and follow us on Twitter @summitplc. Akeso Forward-looking Statement The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. Summit Forward-looking Statements Any statements in this press release about the Company's future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company's product candidates, the therapeutic potential of the Company's product candidates, the potential commercialization of the Company's product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, the impact of the COVID-19 pandemic on the Company's operations and clinical trials, potential acquisitions and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the results of our evaluation of the underlying data in connection with the topline results of our Phase III Ri-CoDIFy study evaluating ridinilazole, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, and global public health crises, including the coronavirus COVID-19 outbreak, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company's pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" section of filings that the Company makes with the Securities and Exchange Commission. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ridinilazole. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing the Company's views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release. Company Codes: HongKong:9926