Lumen生物科学的LMN-201在RePreve试验的初步队列中实现了100%的艰难梭菌初始临床治愈率-动脉网

Lumen Bioscience's LMN-201 Achieves 100% Initial C. difficile Clinical Cure in Preliminary Cohort of RePreve Trial

CISION 等信源发布 2025-04-03 19:00

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可切换为仅中文

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Strong potential to disrupt market for treatment of C. diff infections

具有颠覆艰难梭菌感染治疗市场的强大潜力

—

RePreve Trial main cohort now recruiting

RePreve试验主要队列现在正在招募

SEATTLE

西雅图

，

April 3, 2025

2025年4月3日

/PRNewswire/ -- In a landmark achievement for its pioneering spirulina-based drug development platform, Lumen announced today top-line results from the sentinel cohort of its

/PRNewswire/ -- Lumen 今天宣布了其基于螺旋藻的开创性药物开发平台的一个重要里程碑，公布了其 sentinel 队列的初步结果。

RePreve Clinical Trial

RePreve临床试验

evaluating LMN-201 for

评估 LMN-201 用于

Clostridioides difficile

艰难梭菌

infection (CDI).

感染（CDI）。

LMN-201 is an

LMN-201 是一个

oral biologic cocktail

口服生物鸡尾酒

, delivered in capsules, intended for use with and following antibiotics to improve clinical outcomes for

，以胶囊形式提供，旨在与抗生素一起使用并随后使用，以改善临床结果

C. difficile

艰难梭菌

infection. It is made with Lumen's

感染。它是用Lumen的

proprietary

专有的

spirulina-based GMP manufacturing system.

基于螺旋藻的GMP制造系统。

继续阅读

C. difficile infection sustained clinical cure through week 4 after dosing in the RePreve Trial sentinel cohort and bezlotoxumab and placebo cohorts of the MODIFY I and II trial. Error bars indicate 95 % confidence intervals.

在RePreve试验的前哨队列以及MODIFY I和II试验的贝佐托单抗和安慰剂队列中，艰难梭菌感染在给药后第4周持续临床治愈。误差线表示95%置信区间。

Top-line results:

顶线结果：

100% Initial Clinical Cure:

100% 初始临床治愈率：

21 patients completed 7 days of LMN-201 plus standard of care (SoC) antibiotics (metronidazole, vancomycin, or fidaxomicin). All patients (21/21; 95% confidence interval (CI) 85%-100%) achieved initial clinical resolution, significantly outperforming (p<<0.001) the 80% initial clinical cure rate (625/781; 95% CI 77-83%) observed in the active arm of the large .

21名患者完成了7天的LMN-201加标准护理（SoC）抗生素（甲硝唑、万古霉素或非达霉素）治疗。所有患者（21/21；95%置信区间（CI）85%-100%）均达到了初始临床缓解，显著优于（p<<0.001）大型试验中活动组观察到的80%初始临床治愈率（625/781；95% CI 77-83%）。

MODIFY

修改

I and II studies. The RePreve Trial was designed to facilitate comparisons to the MODIFY trial, which targeted the same patient population with the same SoC antibiotics combined with the IV-infused monoclonal antibody, bezlotoxumab. Patient demographics were similar between RePreve and MODIFY I/II..

我和II研究。RePreve试验旨在便于与针对相同患者群体的MODIFY试验进行比较，该试验采用相同的SoC抗生素联合静脉注射单克隆抗体贝佐洛单抗。RePreve和MODIFY I/II之间的患者人口统计数据相似。

Significantly Enhanced 28-day Sustained Clinical Cure.

显著增强的28天持续临床治愈。

What matters most to patients and healthcare systems alike is 28-day

对患者和医疗系统而言，最重要的是28天

sustained

持续的

clinical cure: the composite of initial clinical cure and prevention of CDI recurrence. Sustained cure rates through Week 4 for SoC alone (MODIFY I/II), SoC plus LMN-201 (RePreve sentinel cohort) and SoC plus bezlotoxumab (MODIFY I/II) were 59.5% (460/773; 95% CI 56-63%), 95.2% (20/21; 95% CI 77-100%) and 68.9% (538/781; 95% CI 66-72%), respectively (see enclosed figure).

临床治愈：初始临床治愈和预防CDI复发的综合结果。单用SoC（MODIFY I/II）、SoC加LMN-201（RePreve哨兵队列）以及SoC加贝佐托珠单抗（MODIFY I/II）在第4周的持续治愈率分别为59.5%（460/773；95% CI 56-63%）、95.2%（20/21；95% CI 77-100%）和68.9%（538/781；95% CI 66-72%）（见附图）。

The improvement in sustained cure through Week 4 between LMN-201 and SoC was 35.7% (p<<0.001) and between LMN-201 and bezlotoxumab was 26.3% (p<0.001)..

在第4周持续治愈率方面，LMN-201与标准治疗（SoC）之间的改善为35.7%（p<<0.001），而LMN-201与贝佐托单抗之间的改善为26.3%（p<0.001）。

Marked CDI Recurrence Reduction:

标记的CDI复发减少：

Only 1 of 21 patients (4.76%; 95% CI 0.24-23%) completing seven days of SoC plus LMN-201 experienced CDI recurrence within 28 days, versus 161 of 621 patients (26%; 95% CI 23-30%) recurrence observed after SoC alone in MODIFY I/II and 87 of 625 (14%; 95% CI 11-17%) after SoC plus bezlotoxumab treatment in MODIFY I/II in the same time period.

在完成7天的标准治疗（SoC）加LMN-201的21名患者中，仅有1名患者（4.76%；95%置信区间0.24%-23%）在28天内出现CDI复发，相比之下，在MODIFY I/II试验中，仅接受标准治疗后，621名患者中有161名（26%；95%置信区间23%-30%）出现复发，而在相同时间段内接受标准治疗加贝佐托单抗治疗的625名患者中，有87名（14%；95%置信区间11%-17%）出现复发。

Of the 21 subjects in the RePreve Trial sentinel cohort who completed seven days of LMN-201, 16 received vancomycin, 4 fidaxomicin, and 1 metronidazole. By comparison, in the Phase 3 trial for Vowst®, patients with three or more prior CDI recurrences who received placebo after vancomycin and fidaxomicin were associated with eight-week CDI recurrence rates of 38% and 46%, respectively (Figure 2 .

在RePreve试验哨兵队列中完成七天LMN-201疗程的21名受试者中，16人接受了万古霉素，4人接受了非达索米星，1人接受了甲硝唑。相比之下，在Vowst®的第三阶段试验中，接受万古霉素和非达索米星后使用安慰剂的三例或更多次CDI复发患者，分别与38%和46%的八周CDI复发率相关（图2）。

here

这里

), illustrating the profound opportunity for improvement in current recurrence rates.

），说明当前复发率有极大的改进空间。

LMN-201 Appears to be Safe and Well-Tolerated:

LMN-201 似乎安全且耐受性良好：

No dose-related severe or serious adverse events were reported.

没有报告与剂量相关的严重或重度不良事件。

Notably, these sentinel cohort results were achieved with only 7 days of dosing. In the RePreve Trial's main cohort (Part B), the LMN-201 dosing window will increase from 7 days to ~70 days (until 8 weeks after initial clinical cure). This will offer protection throughout the period of greatest risk of CDI recurrence: the weeks immediately after antibiotics treatment when the healthy commensal microbiome naturally re-engrafts..

值得注意的是，这些哨兵队列结果仅通过7天的给药就实现了。在RePreve试验的主要队列（B部分）中，LMN-201的给药窗口将从7天延长至约70天（直至初次临床治愈后8周）。这将在CDI复发风险最高的时期提供保护：即抗生素治疗后的数周内，当健康的共生微生物组自然重新植入时。

Observations from the Researchers

研究人员的观察结果

'The sentinel cohort data provide strong initial validation for our multi-component approach to CDI,' said

“哨点队列数据为我们的多组分CDI方法提供了有力的初步验证，”

Dr.

博士

George McDonald

乔治·麦克唐纳

, Consultant to Lumen and Emeritus Professor of Medicine at the

，Lumen顾问，医学荣休教授 tại

University of Washington

华盛顿大学

. 'Seeing zero failures after initial combination treatments and a low recurrence rate in this high-risk group is extremely encouraging. It suggests that LMN-201's tandem mechanism – targeting both the C. diff bacterium and its toxin – can improve outcomes, as it did in preclinical studies.' He noted that achieving 100% initial clinical cure, even in a small cohort, is a rarity in published CDI treatment trials.

“在高风险组中，初始联合治疗后零失败和低复发率是非常令人鼓舞的。这表明LMN-201的双重机制——同时针对艰难梭菌和其毒素——能够改善治疗结果，正如在临床前研究中所表现的那样。”他指出，即使是在一个小队列中实现100%的初始临床治愈，在已发表的CDI治疗试验中也是很少见的。

'While our sample size is limited, such an outcome gives us confidence as we move forward,' he said. 'It's a promising sign, suggesting that LMN-201 could significantly improve patient outcomes and reduce recurrence—the holy grail in C. diff management.'.

“虽然我们的样本量有限，但这样的结果让我们在前进的过程中充满信心，”他说道。“这是一个充满希望的迹象，表明 LMN-201 可以显著改善患者的预后并减少复发——这是 C. diff 管理中的圣杯。”

'We are pleased that LMN-201 appears to be safe and well-tolerated in patients,' added

“我们很高兴LMN-201在患者中似乎是安全且耐受性良好的，”他补充道。

Lumen's CEO and cofounder,

Lumen的首席执行官兼联合创始人，

Brian Finrow

布赖恩·芬罗

. 'This was our first opportunity to observe LMN-201's effects in a clinical setting, in patients with active C. diff, and the absence of dose-related adverse events is reassuring. We can now proceed to the placebo-controlled phase with a solid foundation of safety and an encouraging preliminary efficacy signal.

“这是我们在临床环境中首次观察LMN-201对活动性艰难梭菌感染患者的效果，未出现与剂量相关的不良事件令人感到安心。我们现在可以基于坚实的安全性基础和令人鼓舞的初步疗效信号，进入安慰剂对照阶段。”

We look forward to confirming these results in the larger trial, which is recruiting now.'.

我们期待在正在招募的大规模试验中确认这些结果。

Dr.

博士

Jim Roberts

吉姆·罗伯茨

, Lumen's cofounder and CSO

，Lumen的联合创始人兼首席战略官

, concluded: 'The formidable amount of novelty built into the Lumen platform comes with substantial challenges, but also the potential for great leaps forward in biologic drug development. We are seeing here the realization of that potential.'

`, 总结道：“Lumen 平台内置的大量创新伴随着巨大的挑战，但也有可能在生物药物开发方面实现巨大的飞跃。我们在这里看到了这种潜力的实现。”`

If borne out in future studies, the RePreve Trial will mark a major advance in the CDI field. Bezlotoxumab did not improve initial clinical cure rates and only modestly improved CDI recurrence, but came with a risk of heart failure on its label; it was recently withdrawn from the market. Some FMT-based products have reported encouraging results in CDI recurrence prevention, but, due to fundamental incompatibility with antibiotics, cannot be used to improve initial clinical cure rates..

如果未来的研究能够证实，RePreve 试验将标志着 CDI 领域的一项重大进展。贝佐鲁单抗并未提高初始临床治愈率，仅在 CDI 复发方面有适度改善，但其标签上注明存在心力衰竭风险；该药物最近已退出市场。一些基于 FMT 的产品在预防 CDI 复发方面报告了令人鼓舞的结果，但由于与抗生素的根本不兼容性，无法用于提高初始临床治愈率。

Clinical researchers interested in exploring other uses of LMN-201 in investigator-initiated trials are encouraged to email

有兴趣在研究者发起的试验中探索LMN-201其他用途的临床研究人员，欢迎通过电子邮件联系。

trials@lumen.bio

。

RePreve Trial Design

再预防试验设计

The RePreve Trial has a two-part design. Enrollment criteria are the same in both cohorts, and, to facilitate comparison, they are nearly identical to those used in the

RePreve试验采用两部分设计。两个队列的入组标准相同，为了便于比较，这些标准几乎与那些在

MODIFY trial

修改试验

for bezlotoxumab.

贝佐洛单抗。

Part A

A部分

(Sentinel Cohort) was designed to confirm LMN-201's safety in high-risk individuals with CDI, and to allow Lumen to optimize the trial infrastructure and patient recruiting. Twenty-one CDI patients on standard antibiotic therapy were enrolled. All participants in this open-label cohort received LMN-201 in addition to antibiotics, starting within 7 days of diagnosis..

（哨兵队列）旨在确认LMN-201在高危CDI患者中的安全性，并允许Lumen优化试验基础设施和患者招募。共有21名接受标准抗生素治疗的CDI患者入组。该开放标签队列中的所有参与者均在接受抗生素治疗的同时，在诊断后7天内开始使用LMN-201。

With the sentinel cohort successfully completed, Lumen has begun

随着哨兵队列成功完成，Lumen已经开始了

Part B (main cohort)

B部分（主要队列）

. This pivotal portion is a randomized,

。这一关键部分是随机的，

double-blind, placebo-controlled

双盲、安慰剂对照

study that will enroll approximately

研究将招募大约

350 patients

350名患者

at research centers across the U.S. Participants are randomized 1:1 to receive either LMN-201 or placebo—in each case alongside standard antibiotic therapy—to rigorously evaluate the drug's efficacy in a larger population. The primary endpoint is 'sustained clinical cure' (initial clinical cure plus no recurrence at 12 weeks) relative to placebo.

在美国各地的研究中心进行。参与者以1:1的比例随机分配接受LMN-201或安慰剂——每种情况下均与标准抗生素治疗联合使用——以在更大规模人群中严格评估该药物的疗效。主要终点是相对于安慰剂的“持续临床治愈”（初步临床治愈且在12周内无复发）。

Researchers and participants interested in participating are encouraged to email .

研究人员和有兴趣参与的参与者请发送电子邮件。

trials@lumen.bio

or visit the official

或访问官方网站

RePreve study webpage

RePreve研究网页

。

Background on

背景信息

C. difficile

艰难梭菌

infection

感染

CDI remains a serious and costly problem. Nearly half a million cases occur in the U.S. each year, leading to an estimated ~29,000 deaths and

CDI仍然是一个严重且代价高昂的问题。美国每年发生近50万例，导致约29,000人死亡，并且

~$5 billion

约50亿美元

in hospital costs. Recurrent CDI drives much of this burden: patients who relapse often require extended hospital care and may suffer multiple recurrences. Antibiotic resistance remains a big concern too. CDI is

住院费用方面。复发性CDI是这一负担的主要原因：复发的患者通常需要延长住院护理，并可能多次复发。抗生素耐药性仍然是一个重大问题。CDI是

listed

列出

as an antimicrobial resistance 'Urgent Threat' by the U.S. Centers for Disease Control and Prevention, and researchers are concerned about growing

被美国疾病控制与预防中心列为抗微生物药物耐药性的“紧急威胁”，研究人员对日益增长的态势表示担忧。

resistance

电阻

to vancomycin, the main antibiotic used in CDI treatment. Until now, efforts to improve CDI outcomes have had limited impact, due in part to high costs and inconvenient administration of other preventive therapeutics.

万古霉素，这是治疗CDI的主要抗生素。到目前为止，由于其他预防性治疗的高成本和给药不便，改善CDI结果的努力影响有限。

About LMN-201 and Lumen Bio

关于LMN-201和Lumen Bio

LMN-201 is orally delivered (capsules; no enema or 'bowel cleanse' required) and highly scalable, allowing for much broader potential use in routine CDI management. Lumen previously released a preprint with LMN-201's

LMN-201 通过口服给药（胶囊；无需灌肠或“肠道清洁”），具有高度可扩展性，从而在常规 CDI 管理中拥有更广泛的潜在用途。Lumen 此前曾发布了一份关于 LMN-201 的预印本。

pre-clinical data

临床前数据

. A manuscript for peer-reviewed publication is in preparation, to include results of this sentinel cohort (

一份用于同行评审发表的手稿正在准备中，将包括该哨点队列的结果 (

NCT05330182

) and an earlier trial assessing LMN-201's safety, tolerability, and gastrointestinal pharmacokinetics (

）以及之前评估LMN-201的安全性、耐受性和胃肠道药代动力学的试验（

NCT04893239

）。

Seattle

西雅图

-based Lumen Bioscience has developed a new spirulina-based drug discovery, manufacturing and delivery platform for highly prevalent diseases that have been difficult to address with conventional biopharmaceutical tools. The company's unique platform offers the potential to transform the biologics industry through increased speed, straightforward assembly of cocktail therapeutics, mass-market scale, and exponentially lower costs than legacy approaches..

基于螺旋藻的Lumen生物科学公司已经开发出一个新的药物发现、制造和递送平台，用于处理那些传统生物制药工具难以应对的高度普遍存在的疾病。该公司独特的平台提供了通过提高速度、简单组合鸡尾酒疗法、大众市场规模以及比传统方法呈指数级更低的成本来转变生物制品行业的潜力。

About the Funding Agency, CDMRP

关于资助机构，CDMRP

The work was supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of

这项工作得到了国防部认可的国防卫生事务助理部长的支持，金额为

$16,288,194

16,288,194美元

through the Peer Reviewed Medical Research Program under Award No. HT9425-23-1-0959. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of Defense.

通过同行评审医学研究计划（Peer Reviewed Medical Research Program）第HT9425-23-1-0959号奖项支持。本文的观点、解释、结论和建议均为作者个人意见，不一定得到国防部卫生事务助理部长或国防部的认可。

Media Contact

媒体联系人

：

Julie Rathbun

朱莉·拉思本

+1.206.769.9219

jrathbun@lumen.bio

SOURCE Lumen Bioscience

来源：Lumen Bioscience

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