CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today provided clinical trial and regulatory updates for its lead program sebetralstat, in development as a potential oral on-demand therapy for hereditary angioedema (HAE)..

CAMBRIDGE，Mass。＆SALISBURY，England-（BUSINESS WIRE）-KalVista Pharmaceuticals，Inc。（纳斯达克股票代码：KALV），一家临床阶段制药公司，专注于口服小分子蛋白酶抑制剂的发现，开发和商业化，今天为其主要计划sebetralstat提供临床试验和监管更新，作为遗传性血管性水肿（HAE）的潜在口服按需治疗方法正在开发中。。

Clinical Trial and Regulatory Updates:

临床试验和监管更新：

KalVista has achieved the targeted number of on-treatment attacks required to complete the phase 3 KONFIDENT trial. The trial is a cross-over study in which patients are intended to treat a total of three attacks: one each with 300 mg sebetralstat, 600 mg sebetralstat and placebo, given in a randomized sequence..

KalVista已经达到了完成3期KONFIDENT试验所需的有针对性的治疗攻击次数。该试验是一项交叉研究，其中患者旨在治疗总共三种发作：一种以随机顺序给予300 mg sebetralstat，600 mg sebetralstat和安慰剂。。

Topline data readout is expected in early 2024, remaining on track for a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in the first half of 2024. The Company also expects to file for approval in the European Union and Japan later in 2024.

预计将于2024年初公布Topline数据，以便在2024年上半年向美国食品和药物管理局（FDA）提交新药申请（NDA）。该公司还预计在2024年晚些时候提交欧盟和日本的批准。

KONFIDENT randomized a total of 136 participants from 66 sites across 20 countries, making it the largest clinical trial ever conducted in HAE based on number of subjects. The enrolled patients are representative of the global HAE population and include participants 12 years of age and above, with or without long-term prophylaxis, with all attack locations eligible for treatment, including the larynx..

KONFIDENT随机分配了来自20个国家66个地点的136名参与者，使其成为有史以来在HAE中根据受试者数量进行的最大的临床试验。入选患者代表全球HAE人群，包括12岁及以上的参与者，无论是否进行长期预防，所有发作部位均符合治疗条件，包括喉部。。

In addition, the KONFIDENT-S open label extension study continues to enroll, and the Company expects it will provide a robust safety database to support the planned NDA filing. In total, more than 600 attacks have been treated across KONFIDENT and KONFIDENT-S, and KONFIDENT-S includes numerous patients who have taken multiple doses for treatment as well as short-term prophylaxis..

此外，KONFIDENT-S开放标签扩展研究继续报名，公司预计将提供强大的安全数据库来支持计划的NDA提交。KONFIDENT和KONFIDENT-S总共治疗了600多次发作，KONFIDENT-S包括许多服用多剂量治疗和短期预防的患者。。

“We are excited to have reached the number of on-treatment attacks required for completion of KONFIDENT,” said Andrew Crockett, Chief Executive Officer of KalVista. “We have now initiated study closeout activities which enables topline data readout in early 2024, maintaining the timing of our planned NDA submission in the first half of 2024.

卡维斯塔首席执行官安德鲁·克罗克特（Andrew Crockett）说：“我们很高兴能够达到完成KONFIDENT所需的治疗攻击次数。”。“我们现在已经启动了研究收尾活动，可以在2024年初读出数据，并在2024年上半年保持计划提交NDA的时间。

We are grateful and highly encouraged by the overwhelming interest in this trial from people living with HAE and, if approved, we look forward to introducing a novel therapeutic that offers the potential to transform the treatment of this disease.”.

我们对HAE患者对这项试验的压倒性兴趣表示感谢和高度鼓舞，如果获得批准，我们期待推出一种新的治疗方法，为改变这种疾病的治疗方法提供潜力。”。

About KalVista Pharmaceuticals, Inc.

关于KalVista制药公司。

KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors for diseases with significant unmet need. KalVista is developing sebetralstat as an oral on-demand therapy for HAE and has achieved target enrollment for the phase 3 KONFIDENT clinical trial.

KalVista Pharmaceuticals，Inc。是一家制药公司，专注于口服，小分子蛋白酶抑制剂的发现，开发和商业化，用于具有显着未满足需求的疾病。KalVista正在开发sebetralstat作为HAE的口服按需治疗，并已实现3期KONFIDENT临床试验的目标注册。

In addition, KalVista’s oral Factor XIIa inhibitor program represents a new generation of therapies that may further improve the treatment for people living with HAE and other diseases..

此外，KalVista的口服因子XIIa抑制剂计划代表了新一代疗法，可以进一步改善对HAE和其他疾病患者的治疗。。

For more information about KalVista, please visit www.kalvista.com.

有关KalVista的更多信息，请访问www.KalVista.com。

For more information on the sebetralstat HAE on-demand Phase 3 KONFIDENT study, please visit www.konfidentstudy.com.

有关sebetralstat HAE按需3期KONFIDENT研究的更多信息，请访问www.konfidentstudy.com。

Forward-Looking Statements

前瞻性声明

This press release contains 'forward-looking' statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: 'anticipate,' 'intend,' 'plan,' 'goal,' 'seek,' 'believe,' 'project,' 'estimate,' 'expect,' 'strategy,' 'future,' 'likely,' 'may,' 'should,' 'will' and similar references to future periods.

本新闻稿包含1995年“美国私人证券诉讼改革法案”安全港条款范围内的“前瞻性”声明。前瞻性陈述可以用诸如“预期”，“打算”，“计划”，“目标”，“寻求”，“相信”，“项目”，“估计”，“期望”，“策略”，“未来”，“可能”，“可能”，“应该”，“将会”以及对未来时期的类似引用。

These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of sebetralstat and timing of clinical trials and results, including our Phase 3 KONFIDENT trial, our ability to commence clinical studies or complete ongoing clinical studies, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program.

这些陈述存在许多风险和不确定性，可能导致实际结果与我们的预期大不相同。前瞻性陈述的例子包括，其中包括与FDA沟通的时间或结果，我们对sebetralstat安全性和有效性的期望以及临床试验和结果的时间安排，包括我们的3期KONFIDENT试验，我们开始临床研究的能力或完成正在进行的临床研究，并获得sebetralstat和其他正在开发的候选人的监管批准，sebetralstat商业化的任何努力的成功，sebetralstat和其他正在开发的候选人治疗HAE或其他疾病的能力，以及我们口腔因子XIIa的未来进展和潜在成功计划。

Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2023, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission.

有关可能影响我们业务和财务结果的潜在风险因素的更多信息，请参阅我们与证券交易委员会的文件，包括我们在2023年4月30日结束的年度10-K年度报告，我们的季度报告表格10-Q，以及我们可能与证券交易所不时发布的其他报告。

We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future development.

我们不承担任何义务公开更新可能由于新信息，未来发展而不时发布的任何前瞻性声明，无论是书面还是口头。