Three biotech startups working on new treatments for some of the world’s most challenging medical needs, including a dermatology disease affecting 58 million Americans each year, have made positive progress in their clinical journey. On the other hand, Asceneueron has discontinued its phase 2 clinical trial evaluating its drug candidate evaluating a treatment for Alzheimer’s Disease..

三家生物技术初创公司致力于为一些全球最具挑战性的医疗需求开发新疗法，其中包括每年影响5800万美国人的皮肤病，它们在临床研究中取得了积极进展。另一方面，Asceneuron已停止其评估阿尔茨海默病治疗候选药物的二期临床试验。

LimmaTech Biologics AG

林玛科技生物制品公司

, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, launched the Phase 1 clinical trial (

，一家临床阶段的生物技术公司，正在开发用于预防危及生命的疾病的疫苗，启动了1期临床试验 (

NCT06719219

NCT06719219

) in the U.S. after receiving a Fast Track designation from the U.S. Food and Drug Administration (FDA) in 2024. In February this year, the company announced the vaccination of the first participants in the Phase 1 study evaluating LBT-SA7, a drug candidate designed to prevent skin and soft tissue infections (SSTIs) caused by the bacterial pathogen Staphylococcus aureus (S.

）在获得美国食品药品监督管理局（FDA）的快速通道资格后，于2024年在美国启动。今年二月，该公司宣布了在评估LBT-SA7的第一阶段研究中为首批参与者接种疫苗的消息，LBT-SA7是一种旨在预防由金黄色葡萄球菌（S. aureus）引起的皮肤和软组织感染（SSTIs）的候选药物。

aureus).   S. aureus infections pose a significant global health challenge, causing an estimated 1 million deaths annually, with 90% of all community-acquired S. aureus infections being SSTIs. LBT-SA7 is the first multivalent vaccine entirely based on secreted antigens to address this critical need.

金黄色葡萄球菌感染构成了全球健康的重大挑战，每年导致约100万人死亡，其中90%的社区获得性金黄色葡萄球菌感染为皮肤和软组织感染（SSTIs）。LBT-SA7是首个完全基于分泌抗原的多价疫苗，旨在满足这一关键需求。

It contains weakened forms of the pathogen’s toxins, referred to as toxoids, designed to prevent infections by neutralizing the toxins secreted by S. aureus. .

它含有该病原体毒素的弱化形式，称为类毒素，旨在通过中和金黄色葡萄球菌分泌的毒素来预防感染。

This first-in-human study aims to evaluate the safety and immunogenicity of LBT-SA7 against S. aureus. It is a randomized, double-blinded, and controlled dose-escalation study expected to enrol 130 healthy adults aged 18-50 years. Initial results are anticipated in the second half of 2025. The study is funded by the recently awarded US$6.5 million from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X). .

这项首次人体研究旨在评估LBT-SA7针对金黄色葡萄球菌的安全性和免疫原性。这是一项随机、双盲、对照的剂量递增研究，预计招募130名18-50岁的健康成年人。初步结果预计在2025年下半年公布。该研究由最近获得的来自抗击抗药性细菌生物制药加速器（CARB-X）的650万美元资助。

First ever patient dosed with AlpE in combination with first-line TB Drugs

首次有患者接受AlpE与一线结核病药物联合治疗的剂量

BioVersys

BioVersys

, a clinical-stage company at the forefront of developing novel antibacterial products for serious life-threatening infections caused by multidrug-resistant (MDR) bacteria, has dosed the first patient in a pulmonary TB Phase 2 clinical trial, evaluating the early bactericidal activity (EBA) and safety of alpibectir-ethionamide (AlpE) in combination with first-line TB drugs for the first time.

，一家处于开发针对多重耐药（MDR）细菌引起的严重危及生命的感染的新型抗菌产品前沿的临床阶段公司，已在一项肺结核二期临床试验中为首位患者给药，首次评估了阿比贝克特-乙硫烟胺（AlpE）与一线结核病药物联合使用的早期杀菌活性（EBA）和安全性。

Alpibectir (also known as BVL-GSK098) is a small molecule developed from BioVersys’ Transcriptional Regulatory Inhibitory Compounds (TRIC) platform in a successful collaboration with GSK, the Institut Pasteur Lille and the University of Lille..

Alpibectir（也称为 BVL-GSK098）是一种小分子，由 BioVersys 的转录调控抑制化合物 (TRIC) 平台开发，是与 GSK、里尔巴斯德研究所和里尔大学成功合作的成果。

The study is being conducted under the European Union’s IMI2 UNITE4TB project, through which AlpE is being studied for the first time in a 14-day EBA clinical trial in combination with first-line TB drugs, marking a significant step forward in the further development of this unique combination. Through this Phase 2 TB drug combination trial, BioVersys and its partner GSK seek to get further insights into the potential impact of AlpE in TB patient’s treatments.

该研究是在欧盟IMI2 UNITE4TB项目下进行的，通过该项目，AlpE首次在为期14天的EBA临床试验中与一线结核病药物联合使用，这标志着这一独特组合的进一步开发迈出了重要一步。通过这项二期结核病药物组合试验，BioVersys及其合作伙伴GSK希望进一步深入了解AlpE在结核病患者治疗中的潜在影响。

Under the GSK-BioVersys collaboration agreement, GSK is responsible for developing AlpE for pulmonary indications and BioVersys is addressing TB meningitis (TBM), with BioVersys targeting the start of a TMB trial in H1-2026. This collaborative, two-pronged approach of BioVersys and GSK with their clinical trials partner TASK, aims to expedite the development of AlpE to TB patients..

根据GSK与BioVersys的合作协议，GSK负责开发AlpE用于肺部适应症，而BioVersys则专注于结核性脑膜炎（TBM），目标是在2026年上半年启动TBM试验。BioVersys和GSK与临床试验合作伙伴TASK通过这种协作的双管齐下策略，旨在加速将AlpE提供给结核病患者。

Torqur AG publishes interim phase 2 study results

Torqur AG 发布了二期中期研究结果

Torqur

托克尔

, has announced interim results for the ongoing Phase 2 clinical trial in Actinic keratosis, the most common pre-cancerous dermatological condition, affecting 58 million Americans each year. Primarily driven by an overactive PI3K pathway, early research suggests targeted therapy could hold promise for many patients.

，宣布了正在进行的第二阶段临床试验的中期结果，该试验针对光化性角化病，这是最常见的癌前皮肤病，每年影响 5800 万美国人。早期研究表明，主要由过度活跃的 PI3K 通路驱动，靶向治疗可能为许多患者带来希望。

Torque’s topical bimiralisib, a selective pan-PI3K/mTOR inhibitor, has already demonstrated the potential to prevent or slow down the progression of subclinical AK lesions in pre-clinical studies. The phase 2 clinical study, which started in 2024, evaluates the safety and efficacy of bimiralisib, in patients with Actinic keratosis. .

Torque的局部用药bimiralisib，作为一种选择性泛PI3K/mTOR抑制剂，已经在临床前研究中显示出预防或减缓亚临床AK病灶进展的潜力。这项始于2024年的二期临床研究正在评估bimiralisib在光化性角化病患者中的安全性和有效性。

Key interim findings include:

关键的中期发现包括：

Efficacy: Bimiralisib topical gel (2%) demonstrated strong efficacy, with 60% of patients who completed the initial treatment and follow-up visit showing either complete or partial clearance of their lesions. Notably, 70% in the 4-week treatment group (Arm B, 17 patients) and 50% in the 2-week treatment group (Arm A, 18 patients) showed significant improvement, reinforcing its potential as an effective targeted therapy for Actinic keratosis..

疗效：Bimiralisib外用凝胶（2%）表现出显著的疗效，在完成初始治疗和随访的患者中，有60%的患者显示出病灶完全或部分清除。值得注意的是，4周治疗组（B组，17名患者）中有70%的患者和2周治疗组（A组，18名患者）中有50%的患者表现出显著改善，进一步证明了其作为光化性角化病有效靶向治疗的潜力。

Safety: The safety profile indicates that bimiralisib topical gel (2%) was well tolerated, with treatment-related adverse events primarily being mild (Grade 1) and resolving quickly after treatment completion

安全性：安全性概况表明，2%的bimiralisib外用凝胶耐受性良好，治疗相关的不良事件主要为轻度（1级），并在治疗结束后迅速缓解。

The company is enrolling patients across two renowned dermatology centers in Switzerland.

该公司正在瑞士的两家著名皮肤病学中心招募患者。

Asceneuron discontinues Phase 2 trials

Asceneuron停止了第二阶段的试验。

In July last year,

去年七月，

Asceneuron

阿森内伦

obtained over $100 to accelerate the development of its lead asset ASN51, an oral small molecule OGA inhibitor for the treatment of Alzheimer's disease and launch Phase 2 clinical trials. According to the latest updates, the company has made a strategic decision to discontinue the study. The trial, which kicked off in October 2024, was expected to run for two years..

获得了超过1亿美元的资金，以加速其主要资产ASN51的开发，这是一种用于治疗阿尔茨海默病的口服小分子OGA抑制剂，并启动二期临床试验。根据最新更新，该公司已做出战略决策，停止这项研究。该试验于2024年10月启动，原计划持续两年。

The study (NCT06677203) aimed to evaluate two doses of ASN51 against a placebo in 123 patients with early Alzheimer’s, focusing on safety, tolerability, suicide severity assessment through the Columbia-Suicide Severity Rating Scale (C-SSRS), and tau protein levels in cerebrospinal fluid. Asceneuron had previously said that ASN51 could be a disease-modifying therapy, with applications beyond Alzheimer’s in diseases such as Parkinson’s and amyotrophic lateral sclerosis (ALS)..

该研究（NCT06677203）旨在评估两种剂量的ASN51与安慰剂在123名早期阿尔茨海默病患者中的效果，重点关注安全性、耐受性、通过哥伦比亚自杀严重程度评定量表（C-SSRS）评估的自杀严重性，以及脑脊液中的tau蛋白水平。Asceneuron此前曾表示，ASN51可能是一种疾病修饰疗法，除了阿尔茨海默病外，还适用于帕金森病和肌萎缩侧索硬化症（ALS）等疾病。

(Press release/RAN)

（新闻稿/随机接入网络）

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