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Eupraxia Pharmaceuticals Announces Positive Data from Highest-Dose Cohort in the Ongoing RESOLVE Trial in Eosinophilic Esophagitis, and Plans for Expansion of EP-104GI Development Programs
Globenewswire· 2025-09-29 21:00
Clinical data was reported for the first time in patients receiving an 8 mg dose per injection (Cohort 9 of the dose escalation portion of RESOLVE), the highest dose planned in this trial. Patients in Cohort 9 experienced the largest improvements in tissue health outcomes and eosinophil reduction observed to date.RESOLVE Safety Committee and members of the Eupraxia Clinical Advisory Board endorsed using the 8 mg dose per injection as the second dose for the ongoing Phase 2b portion of the RESOLVE study.Eupr ...
Eupraxia Pharmaceuticals Announces Closing of US$80.5 Million Public Offering Including Full Exercise of Underwriter Option
Globenewswire· 2025-09-24 12:54
VICTORIA, British Columbia, Sept. 24, 2025 (GLOBE NEWSWIRE) -- Eupraxia Pharmaceuticals Inc. (“Eupraxia” or the “Company”) (NASDAQ:EPRX) (TSX:EPRX), a clinical-stage biotechnology company leveraging its proprietary Diffusphere™ technology designed to optimize local, controlled drug delivery for applications with significant unmet need, is pleased to announce the successful closing of its previously announced public offering (the "Offering") of 14,636,363 common shares of the Company (the “Common Shares"), w ...
Eupraxia Pharmaceuticals Announces Pricing of US$70 Million Public Offering of Common Shares
Globenewswire· 2025-09-23 02:42
VICTORIA, British Columbia, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Eupraxia Pharmaceuticals Inc. (“Eupraxia” or the “Company”) (NASDAQ:EPRX) (TSX:EPRX), a clinical-stage biotechnology company leveraging its proprietary Diffusphere™ technology designed to optimize local, controlled drug delivery for applications with significant unmet need, today announced the pricing of its previously announced public offering (the "Offering") of 12,727,273 common shares of the Company (the “Common Shares") at a price to the pu ...
Eupraxia Pharmaceuticals Announces Proposed Public Offering of Common Shares
Globenewswire· 2025-09-22 20:01
VICTORIA, British Columbia, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Eupraxia Pharmaceuticals Inc. (“Eupraxia” or the “Company”) (NASDAQ:EPRX) (TSX:EPRX), a clinical-stage biotechnology company leveraging its proprietary Diffusphere™ technology designed to optimize local, controlled drug delivery for applications with significant unmet need, is pleased to announce the Company has filed a preliminary prospectus supplement (the “Supplement”) to its short form base shelf prospectus dated February 5, 2024 (the “Base ...
First Set of 1-Year Clinical Results from RESOLVE Trial in Eosinophilic Esophagitis (EoE), Durable and Sustained Symptom & Tissue Responses after Dosing with EP-104GI
Globenewswire· 2025-09-02 12:00
文章核心观点 - Eupraxia Pharmaceuticals宣布其候选药物EP-104GI在治疗嗜酸性食管炎(EoE)的1b/2a期RESOLVE试验中表现出持久的症状缓解和组织健康改善 包括52周的长期数据 支持其作为一年一次疗法的潜力[1][2][3] 临床试验结果 - 4mg剂量组患者在12周时达到56%的临床缓解率(n=9) 24周时提升至78%(n=9) 36周和52周均维持在67%(n=6和n=3)[3] - 三分之二接受48mg总剂量(4mg/部位)的患者在12个月后仍处于临床缓解状态[7] - 组织健康评分(EoEHSS)在36周时显示严重程度改善47% 范围改善44%[8] - 试验中未报告严重不良事件(SAE)或口腔/胃肠道念珠菌感染病例[7][9] 药代动力学特征 - 4mg剂量组患者血浆中氟替卡松浓度在52周内保持稳定且可预测 水平远低于每日哮喘吸入剂的典型浓度[9] 疾病背景与市场机会 - 嗜酸性食管炎(EoE)在美国影响超过45万人 发病率和患病率迅速增长[17] - 独立市场研究显示多数EoE患者每年至少接受一次常规内镜检查 与EP-104GI一年一次给药方案高度契合[2] 公司技术与研发进展 - Eupraxia利用专有Diffusphere™技术实现局部控制药物递送 旨在提高疗效并减少不良反应[18] - RESOLVE试验的2b期部分(随机安慰剂对照研究)已于2025年启动 预计2026年第三季度公布顶线数据[15] - 公司管线包括针对炎症性关节疾病和肿瘤学的长效制剂候选药物[19]
Eupraxia Pharmaceuticals Reports Second Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-08-12 20:25
公司财务表现 - 2025年第二季度净亏损870万美元,较2024年同期的610万美元亏损扩大,主要因研发成本、行政费用及其他支出增加 [4] - 截至2025年6月30日现金储备为1980万美元,较2024年第四季度的3310万美元下降,资金主要用于EP-104临床试验及日常运营 [5] - 现有现金及权证行权预期资金可支撑运营至2026年第三季度 [6] - 公司普通股发行量3596万股,优先股890万股 [6] 临床进展与产品管线 - EP-104GI治疗嗜酸性食管炎(EoE)的RESOLVE试验进入2b期安慰剂对照阶段,计划在全球25个中心招募至少60名患者,评估组织健康及症状评分,顶线数据预计2026年下半年公布 [8][9] - 1b/2a期RESOLVE试验显示3名患者接受EP-104GI治疗9个月后疗效持续或改善,无严重不良事件报告 [2][9] - 2025年10月将公布1b/2a期5-8队列的额外数据 [8] - EP-104IAR治疗膝骨关节炎疼痛的2b期试验(SPRINGBOARD)已达到主要终点及3项次要终点 [15] 技术平台与战略定位 - 专有Diffusphere™技术通过聚合物微球实现局部缓释给药,可优化现有药物及新药的靶向递送,潜在减少不良反应并延长疗效持续时间 [14] - 技术平台应用领域涵盖疼痛、炎症性胃肠疾病、肿瘤及感染性疾病,可能改变现有药物的安全性、耐受性和疗效 [14][15] - EP-104GI通过食管壁注射实现局部给药,为EoE提供独特治疗方案 [15] 运营动态与行业活动 - 2025年5月举办KOL线上会议讨论EP-104GI的1b/2a期数据 [9] - 管理层计划出席2025年8-9月多个投资会议(Canaccord、Citi、Cantor、H C Wainwright) [12] - 公司在美国通过第三方生产临床供应的EP-104IAR及EP-104GI,并持有美元资金以支付美元费用 [10][11] 贸易政策影响 - 管理层持续评估2025年2月美国对加关税及加拿大报复性关税对业务的潜在直接/间接影响,目前预期不影响美国供应链 [10][11]