Immuron proceeding to Phase 3 registration strategy with the FDA

Immuron在FDA进行第三阶段注册策略

Travelan® topline clinical trial results demonstrate protective efficacy with single daily dose

Travelan®topline临床试验结果表明，单次每日剂量具有保护作用

36.4% protective efficacy against Enterotoxigenic Escherichia coli (ETEC) induced moderate to severe diarrhea was observed in the Travelan® group compared to the placebo group (primary endpoint)

与安慰剂组（主要终点）相比，Travelan®组对肠毒素大肠杆菌（ETEC）引起的中度至重度腹泻的保护率为36.4%

66.7% protective efficacy against ETEC induced severe diarrhea was observed in the Travelan® group compared to the placebo group (secondary endpoint)

与安慰剂组相比，Travelan®组对ETEC引起的严重腹泻有66.7%的保护作用（次要终点）

83.3% statistically significant reduction in the number of subjects in the Travelan® group requiring early antibiotic treatment post challenge compared to the placebo (secondary endpoint)

与安慰剂相比，Travelan®组需要早期抗生素治疗的受试者数量在统计学上显着减少了83.3%（次要终点）

100% of the subjects requiring IV fluids post challenge were in the placebo (secondary endpoint)

100%需要静脉输液的受试者服用安慰剂（次要终点）

55.6% reduction in the number of subjects experiencing adverse events associated with the ETEC challenge observed in the Travelan® group compared to the placebo group (secondary endpoint)

与安慰剂组（次要终点）相比，Travelan®组观察到的与ETEC挑战相关的不良事件的受试者数量减少了55.6%

Phase 2 clinical study data supports the excellent safety and tolerability profile of Travelan®

第二阶段临床研究数据支持Travelan®出色的安全性和耐受性

MELBOURNE, Australia, March 07, 2024 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce the interim topline results confirming that a single daily dose of Travelan® is effective in prevention of moderate to severe diarrhea following challenge with enterotoxigenic Escherichia coli (ETEC)..

澳大利亚墨尔本，2024年3月7日（环球通讯社）--Immuron Limited（ASX:IMC；NASDAQ:IMRN）是一家总部位于澳大利亚的全球一体化生物制药公司，很高兴宣布临时topline结果，证实单次每日剂量的Travelan®可有效预防肠毒素大肠杆菌（ETEC）攻击后的中度至重度腹泻。。

Immuron was awarded AU $4.8 (USD $3.43) million funding by the U.S. Department of Defense (ASX Announcement 12 January 2022) to perform a randomized double-blind placebo-controlled phase 2 controlled human infection model (CHIM) study to assist with evaluating a dosing regimen that is most suited to deployed US troops visiting developing countries.

Immuron获得了美国国防部（ASX公告，2022年1月12日）480万澳元（343万美元）的资金，用于进行一项随机双盲安慰剂对照的2期对照人类感染模型（CHIM）研究，以帮助评估最适合部署在发展中国家的美国军队的给药方案。

Healthy volunteers were recruited and randomly assigned to receive a single daily oral dose of 1200 mg of Travelan® or placebo. Dosing commenced 2 days prior to challenge with ETEC strain H10407 and continued for 7 days. ClinicalTrials.gov Identifier: NCT05933525..

招募健康志愿者并随机分配接受每日单次口服1200毫克Travelan®或安慰剂。在用ETEC菌株H10407攻击前2天开始给药，并持续7天。ClinicalTrials.gov标识符：NCT05933525。。

This interim analysis summarizes the data for a total of 60 subjects who have completed the inpatient challenge component of this current clinical study. Last patients last visits are anticipated to commence in April this year and final clinical study report will be completed in H2 2024.

这项中期分析总结了总共60名完成本临床研究住院挑战部分的受试者的数据。最后一名患者最后一次就诊预计将于今年4月开始，最终临床研究报告将于2024年下半年完成。

Having demonstrated protective efficacy in two published clinical studies (Otto et al., 2011), this Phase 2 study was designed to compare the preventative effects of once daily dosing to the current standard recommended treatment of three times daily dosing. To learn more about Phase 2 study design, read: U.S.

在两项已发表的临床研究中证明了保护作用（Otto等，2011），这项2期研究旨在比较每日一次给药的预防效果与目前标准推荐的每日三次给药的治疗效果。要了解有关第二阶段研究设计的更多信息，请阅读：美国。

Food and Drug Administration Step 3: Clinical Research.

食品和药物管理局第3步：临床研究。

IMM-124E (Travelan®) will be the first product developed with Immuron’s platform technology to proceed into Phase 3 clinical trials. The underlying nature of Immuron’s platform technology enables the development of medicines across a large range of infectious diseases. The platform can be used to block viruses or bacteria at mucosal surfaces such as the Gastrointestinal tract and neutralize the toxins they produce.

IMM-124E（Travelan®）将是使用Immuron平台技术开发的第一款进入3期临床试验的产品。Immuron平台技术的潜在性质使得能够开发跨越多种传染病的药物。该平台可用于阻断胃肠道等粘膜表面的病毒或细菌，并中和它们产生的毒素。

More information on Immuron’s platform technology can be found below..

有关Immuron平台技术的更多信息，请参见下文。。

Travelan® demonstrated clinical efficacy in preventing ETEC-attributable diarrhea in two previous CHIM studies (Table 1). These studies showed dosing 400 mg three times daily, resulted in 76.7% (p=0.007) to 90.9% (p=0.0005) protection (Otto et al., 2011).

Travelan®在之前的两项CHIM研究中证明了预防ETEC归因性腹泻的临床疗效（表1）。这些研究表明，每天三次服用400 mg，可产生76.7%（p=0.007）至90.9%（p=0.0005）的保护作用（Otto等，2011）。

This trial demonstrated protective efficacy* with once daily dosing even though the attack rate for this study was much lower than planned. The intended attack rate (percentage of subjects with ETEC-induced moderate- severe diarrhea) for this study was approximately 70%. The attack rate for the Placebo group of this study was only 37% (Table 2).

这项试验证明了每天一次给药的保护效果*，即使这项研究的发病率远低于计划。本研究的预期发作率（ETEC诱导的中重度腹泻受试者的百分比）约为70%。本研究安慰剂组的发作率仅为37%（表2）。

Given the lower than planned attack rate, this current study is underpowered to appropriately detect a significant difference in moderate to severe ETEC attributed diarrhea in the Placebo group compared to the Treatment group. This makes the demonstration of protective efficacy and reduction in adverse events and diarrheal symptoms particularly noteworthy..

鉴于发病率低于计划，目前的研究不足以适当检测安慰剂组与治疗组相比中度至重度ETEC归因腹泻的显着差异。这使得保护功效的证明以及不良事件和腹泻症状的减少特别值得注意。。

The company will now proceed to hold an end of Phase 2 meeting with the U.S Food and Drug Administration to discuss the pivotal Phase 3 registration strategy and planned clinical trials including recommended dosing to support a Biologics License Application (BLA) for Travelan® as a prophylactic medicine for Travelers’ Diarrhea.

该公司现在将与美国食品和药物管理局举行第二阶段结束会议，讨论关键的第三阶段注册策略和计划的临床试验，包括推荐剂量，以支持Travelan®作为旅行者腹泻预防药物的生物制剂许可证申请（BLA）。

A preventative treatment that defends against infectious enteric diseases is a high priority objective for the U.S. Military..

预防肠道传染病的预防性治疗是美国军方的首要目标。。

Immuron is in the process of exploring non-dilutive funding opportunities for these Phase 3 clinical trials.

Immuron正在为这些3期临床试验探索非稀释性资助机会。

Topline results:

Topline结果：

Travelan®, a first-in-class, oral antibody therapy, dosed once daily resulted in a reduction ETEC-induced moderate-severe diarrhea compared to placebo.

Travelan®是一流的口服抗体疗法，与安慰剂相比，每天服用一次可减少ETEC引起的中重度腹泻。

ETEC-induced moderate to severe diarrhea was reduced by 36.4% in the Travelan® group compared to the placebo group

与安慰剂组相比，Travelan®组ETEC引起的中度至重度腹泻减少了36.4%

Protective efficacy of once daily dosing shown to be approx. 50% as effective as the current recommended three times daily dosing regimen; this is a strong result given the lower than expected attack rate

每日一次给药的保护效果显示约为目前推荐的每日三次给药方案的50%；鉴于攻击率低于预期，这是一个强有力的结果

66.7% protective efficacy against ETEC induced severe diarrhea was observed in the Travelan® group compared to the placebo group

与安慰剂组相比，Travelan®组对ETEC引起的严重腹泻的保护率为66.7%

Statistically significant reduction of 83.3% in the subjects in the Travelan® group requiring early antibiotic treatment post challenge compared to the placebo

与安慰剂组相比，Travelan®组在挑战后需要早期抗生素治疗的受试者的统计学显着降低了83.3%

For the subjects requiring intravenous rehydration post challenge 100% were in the placebo group and none were in the Travelan® group

对于挑战后需要静脉补液的受试者，安慰剂组为100%，Travelan®组为100%

55.6% reduction in the number of subjects experiencing adverse events post the ETEC challenge was observed in the Travelan® group compared to the Placebo group

与安慰剂组相比，Travelan®组在ETEC挑战后发生不良事件的受试者人数减少了55.6%

Studies using the CHIM for a variety of different enteric pathogens suggest the greatest protection may be against more severe disease and in studies where the disease appears to be predominately mild, which appears to be the case in this study, the efficacy estimates can be lower than anticipated.

使用CHIM治疗各种不同肠道病原体的研究表明，最大的保护作用可能是抵抗更严重的疾病，在疾病似乎主要是轻度的研究中，本研究似乎就是这种情况，疗效估计可能低于预期。

Table 1: Summary of current clinical study data

表1：当前临床研究数据摘要

Event post challenge

挑战后活动

Travelan®

Travelan®

n = 30

n=30

n (%)

氮（%）

Placebo

安慰剂

n = 30

n=30

n (%)

氮（%）

Reduction

减少

in AEs or

在AEs或

Symptoms (%)

症状（%）

P value

P值

Primary Endpoint

主要终点

Number (n) of subjects with ETEC-induced moderate- severe diarrhea

ETEC诱发中重度腹泻的受试者人数（n）

7

7

(23.3%)

(23.3%)

11 (36.7%)

11 (36.7%)

NA

不适用

0.399

0.399

Protective efficacy [%]1

保护效果[%]1

95% 2-sided Confidence Interval2

95%双侧置信区间2

36.4%*

36.4%*

(-79.8%, 79.1%)

(-79.8%, 79.1%)

Secondary Endpoints - Safety and tolerability

次要终点-安全性和耐受性

Number of subjects with an adverse event (AE)

发生不良事件（AE）的受试者人数

95% 2-sided Confidence Interval2

95%双侧置信区间2

4 (13.3%)

4 (13.3%)

(-3.8%, 37.1%)

(-3.8%, 37.1%)

9 (30.0%)

9 (30.0%)

55.6%

55.6%

0.1172

0.1172

Number of subjects with (AEs) fever, nausea, anorexia, or abdominal pain/cramps rated as moderate to severe

发烧、恶心、厌食或腹痛/痉挛被评为中度至重度的受试者人数

95% 2-sided Confidence Interval2

95%双侧置信区间2

3 (10.0%)

3 (10.0%)

(-5.2%, 31.9%)

(-5.2%, 31.9%)

7 (23.3%)

7 (23.3%)

57.1%

57.1%

0.1659

0.1659

Secondary Endpoints – Degree to which a participant experiences diarrheal symptoms

次要终点-参与者出现腹泻症状的程度

Number of subjects who experienced severe diarrhea

经历严重腹泻的受试者人数

95% 2-sided Confidence Interval2

95%双侧置信区间2

1 (3.3%)

1 (3.3%)

(-5.8%, 19.2%)

(-5.8%, 19.2%)

3 (10.0%)

3 (10.0%)

66.7%

66.7%

0.3006

0.3006

Number of subjects requiring early antibiotic treatment

需要早期抗生素治疗的受试者人数

95% 2-sided Confidence Interval2

95%双侧置信区间2

1 (3.3%)

1 (3.3%)

(1.0%, 32.4%)

(1.0%, 32.4%)

6 (20.0%)

6 (20.0%)

83.3%

83.3%

0.0444

0.0444

Number of subjects requiring IV fluids

95% 2-sided Confidence Interval2

95%双侧置信区间2

0

0

(-0.7%, 20.7%)

(-0.7%, 20.7%)

3 (10.0%)

3 (10.0%)

100.0%

100.0%

0.0756

0.0756

1 Fishers exact test and binomial distribution 2 Chi-square test

1 Fishers精确检验和二项分布2卡方检验

AE = Adverse event associated with the ETEC challenge

AE=与ETEC挑战相关的不良事件

* Intent-to-treat analysis set defined as randomized subjects who received study medication and were challenged

*意向治疗分析集定义为接受研究药物治疗并受到挑战的随机受试者

Table 2: Comparison of clinical study data attack rates

表2：临床研究数据发作率的比较

Event post challenge

挑战后活动

Otto3 Study 1

Otto3研究1

Placebo

安慰剂

n = 15

n=15

n (%)

氮（%）

Otto3 Study 2

Otto3研究2

Placebo

安慰剂

n = 14

n=14

n (%)

氮（%）

Current

当前

Travelan® Study

Travelan®研究

n = 30

n=30

n (%)

氮（%）

Number (n) of subjects with ETEC-induced moderate- severe diarrhea

ETEC诱发中重度腹泻的受试者人数（n）

11

11

(73%)

(73%)

12

12

(86%)

(86%)

11

11

(37%)

(37%)

3Otto et al., 2011

3 Otto等人，2011年

Immuron is investigating the impact of the lower than expected attack rate.

Immuron正在调查低于预期的攻击率的影响。

Immuron has filed a provisional patent application with the U.S. Patent Office including results from this trial.

Immuron已向美国专利局提交了一份临时专利申请，其中包括该试验的结果。

This release has been authorized by the directors of Immuron Limited.

此版本已获得Immuron Limited董事会的授权。

COMPANY CONTACT:

公司联系人：

Steven Lydeamore

Steven Lydeamore

Chief Executive Officer

首席执行官

steve@immuron.com

steve@immuron.com

About Immuron

关于Immuron

Immuron Limited (ASX: IMC, NASDAQ: IMRN), is an Australian biopharmaceutical company focused on developing and commercializing orally delivered targeted polyclonal antibodies for the treatment of infectious diseases.

Immuron Limited（ASX:IMC，NASDAQ:IMRN）是一家澳大利亚生物制药公司，专注于开发和商业化用于治疗传染病的口服靶向多克隆抗体。

For more information visit: https://www.immuron.com.au/ and https://www.travelan.com

For more information visit: https://www.immuron.com.au/ and https://www.travelan.com

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