share_log

Acurx Sponsored and Participated in the Peggy Lillis Foundation Inaugural CDI Scientific Symposium and Presented Ibezapolstat Ph2b Clinical Data Update

Acurx Sponsored and Participated in the Peggy Lillis Foundation Inaugural CDI Scientific Symposium and Presented Ibezapolstat Ph2b Clinical Data Update

Acurx赞助并参加了Peggy Lillis基金会首届CDI科学研讨会,并发布了Ibezapolstat Ph20亿临床数据更新
PR Newswire ·  11/18 20:00
  • Acurx is proud to sponsor this inaugural Scientific Symposium of the Peggy Lillis Foundation (PLF) for C. Diff Education & Advocacy
  • An update of ibezapolstat Ph2b clinical and microbiome results was presented
  • Preparation continues to advance ibezapolstat into international Phase 3 clinical trials for treatment of C. difficile Infection (CDI)
  • Acurx continues preparation to submit requests for regulatory guidance to initiate clinical trials in the European Union to be followed by Japan, Canada and the United Kingdom
  • Ibezapolstat has previously received FDA QIDP and Fast-Track Designation from FDA
  • Acurx is proud to sponsor this inaugural Scientific Symposium of the Peggy Lillis Foundation (PLF) for C. Diff Education & Advocacy
  • An update of ibezapolstat Ph20亿 clinical and microbiome results was presented
  • 准备继续将伊贝扎泊斯他推进至国际第三阶段临床试验,用于治疗C. difficile感染(CDI)
  • Acurx continues preparation to submit requests for regulatory guidance to initiate clinical trials in the European Union to be followed by Japan, Canada and the United Kingdom
  • 伊贝扎泊斯他先前已获得FDA QIDP认定和FDA的快速通道认定

STATEN ISLAND, N.Y., Nov. 18, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, with its lead antibiotic candidate, ibezapolstat, preparing to advance to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). The Company today announced its support and participation in the Inaugural Peggy Lillis Foundation (virtual) Scientific Symposium, held on Friday, November 15, 2024.

STATEN ISLAND, N.Y., Nov. 18, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, with its lead antibiotic candidate, ibezapolstat, preparing to advance to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). The Company today announced its support and participation in the Inaugural Peggy Lillis Foundation (virtual) Scientific Symposium, held on Friday, November 15, 2024.

Acurx's Executive Chairman, Bob DeLuccia, delivered opening remarks for the symposium which assembled experts and thought leaders from around the world to present state-of-the art updates regarding C difficile Infection and therapeutic options. Topics covered included epidemiology, bacterial physiology, risk factors for infections, and new and emerging treatment modalities. The Symposium also included testimonials from patients who survived CDI.

Acurx's Executive Chairman, Bob DeLuccia, delivered opening remarks for the symposium which assembled experts and thought leaders from around the world to present state-of-the art updates regarding C difficile Infection and therapeutic options. Topics covered included epidemiology, bacterial physiology, risk factors for infections, and new and emerging treatment modalities. The Symposium also included testimonials from patients who survived CDI.

Kevin Garey, PharmD, MS, FIDSA, Professor and Chair, University of Houston College of Pharmacy, Principal Investigator for microbiology and microbiome aspects of the ibezapolstat clinical trial program, and Acurx Scientific Advisory Board member, delivered a presentation entitled: "Ibezapolstat Preserves Key Clostridium Leptum Species: Microbiome Results from the Phase 2, Randomized, Double-Blind Study."

Kevin Garey, PharmD, MS, FIDSA, Professor and Chair, University of Houston College of Pharmacy, Principal Investigator for microbiology and microbiome aspects of the ibezapolstat clinical trial program, and Acurx Scientific Advisory Board member, delivered a presentation entitled: "Ibezapolstat Preserves Key Clostridium Leptum Species: Microbiome Results from the Phase 2, Randomized, Double-Blind Study."

According to Dr. Garey: "In contrast to patients dosed with vancomycin, ibezapolstat has consistently shown in the phase 1 and 2 studies that it promotes the growth of beneficial Actinobacteria important for short chain fatty acid production and Clostridiales important for bile acid homeostasis. At the same time, it does not promote the overgrowth of potentially harmful Proteobacteria." He further added: "Ibezapolstat showed a favorable secondary to primary ratio of bile acids which is linked to a lower recurrence rate of CDI. I'm excited to see this new antibiotic advance to phase 3 clinical trials for the treatment of acute C. difficile Infection, particularly considering the favorable effects on bile acid homeostasis, which could lead to a reduction in CDI recurrence, a current unmet medical need with currently marketed antibiotics."

根据加里博士的说法:“与万古霉素剂量的患者相比,伊贝热泊司塔 在1和2期研究中一贯显示出促进有益的放线菌菌群生长以及对胆酸稳态重要的梭菌目菌群生长。与此同时,它不会促进潜在有害的变形菌群过度生长。” 他进一步补充说:“伊贝热泊司塔显示出有利的次级到主要胆酸比值,这与低复发率的CDI有关。我很期待这种新的抗生素能进入第3期临床试验,用于治疗急性C.难治性感染,特别是考虑到对胆酸稳态的有利影响,这可能会减少CDI的复发,目前市场上已有的抗生素无法满足的医疗需求。”

Robert J. DeLuccia, Executive Chairman of Acurx, stated: "As a leader in the field with the first new class of antibiotics in decades now preparing to enter Ph3 international trials for the treatment of acute CDI and reduction of recurrence, we are very excited to have sponsored this event to support the PLF and to present an update on ibezapolsat's Ph2b data, particularly during November being CDC-designated as Cdiff Awareness month." Dr. Garey's presentation is available on the Acurx Pharmaceuticals website at .

Acurx的执行主席Robert J. DeLuccia表示:“作为领域的领导者,几十年来首个新类抗生素现在准备进入全球第三阶段试验,以治疗急性CDI并降低复发,我们非常激动赞助此次活动,以支持PLF并介绍伊贝热泊司塔的Ph20亿数据的最新情况,尤其是在11月被CDC指定为Cdiff意识月。” 加里博士的演讲可在Acurx Pharmaceuticals网站上查看 .

Acurx has previously announced that it had a successful FDA End-of-Phase 2 Meeting and Phase 3 Readiness for ibezapolstat for the Treatment of C. difficile Infection. Agreement with FDA was reached on key elements to move forward with its international Phase 3 clinical trial program. Agreement was also reached with FDA on the complete non-clinical and clinical development plan for filing of a New Drug Application (NDA) for marketing approval. Planning continues to advance ibezapolstat into international Phase 3 clinical trials for treatment of C. difficile Infection (CDI). Acurx is also preparing to submit requests for regulatory guidance to initiate clinical trials in the European Union, to be followed by requests to be submitted in the United Kingdom, Japan and Canada.

Acurx此前宣布已成功进行了FDA第2期后续会议,并为ibezapolstat治疗C. difficile感染的临床3期研究做好准备。与FDA就推进国际3期临床试验计划的关键要素达成一致。与FDA达成的协议还涉及提出新药申请(NDA)以获得上市许可的完整非临床和临床发展计划。规划继续推进ibezapolstat进入治疗C. difficile感染(CDI)的国际3期临床试验。Acurx还准备提交申请以获得欧盟的临床试验指导,然后将提交申请在英国、日本和加拿大展开临床试验。

Key elements for the two Phase 3, non-inferiority, pivotal trials were confirmed and included agreement on the protocol design, patient population, primary and secondary endpoints, and size of the registration safety database. Based on FDA recommendations, and in anticipation of an EMA Scientific Advice Meeting, the primary efficacy analysis will be performed using a Modified Intent-To-Treat (mITT) population consistent with EMA requirements. This will result in an estimated 450 subjects in the mITT population, randomized in a 1:1 ratio to either ibezapolstat or standard-of-care vancomycin, enrolled into the initial Phase 3 trial. The trial design not only allows determination of ibezapolstat's ability to achieve Clinical Cure of CDI as measured 2 days after 10 days of oral treatment, but also includes assessment of ibezapolstat's potential effect on reduction of CDI recurrence in the target population. In the event non-inferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority.

确认了两个3期非劣效关键试验的关键要素,并包括对试验设计、病人人群、主要和次要终点,以及注册安全数据库规模的协议。根据FDA的建议,并预期EMA科学咨询会议,主要疗效分析将使用符合EMA要求的经修改的意向治疗人群(mITT)进行。这将导致大约450名受试者参与到mITt人群中,按1:1比例随机分配至ibezapolstat或标准护理范南霉素,入组初期3期试验中。该试验设计不仅允许确定ibezapolstat在接受口服治疗10天后的第2天实现CDI的临床治愈能力,还包括评估ibezapolstat对目标人群中CDI复发减少的潜在影响。如果ibezapolstat对范南霉素的非劣效被证明,将进行进一步的分析以检验是否具有优越性。

About the Peggy Lillis Foundation
The Peggy Lillis Foundation (PFL) is building a nationwide C. DIFF (Clostridioides difficile) awareness movement by educating the public, empowering advocates and shaping public policy. Currently, PLF is going beyond its early beginnings as a patient advocacy group to raise awareness of Cdiff, but now is building a broader foundation by uniting researchers, clinicians, and the medical community, along with all advocates to share groundbreaking research findings, foster collaboration and ultimately enhance cdiff patient outcomes.
For more information about PLF please visit:

关于佩吉·利利斯基金会
佩吉·利利斯基金会(PLF)正在通过教育公众、赋权倡导者和制定公共政策来打造一个全国性的C. DIFF(艰难梭菌)意识运动。目前,PLF不仅在其早期作为患者倡导团体的基础上提高了对Cdiff的认识,而且正在建立一个更广泛的基础,通过联合研究人员、临床医生和医疗界,以及所有倡导者分享开创性的研究发现,促进合作,最终提升Cdiff患者的预后。
要了解更多关于PLF的信息,请访问:

About the Ibezapolstat Phase 2 Clinical Trial
The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial.
(see ). This Phase 2 clinical trial was designed to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI including pharmacokinetics and microbiome changes from baseline. from study centers in the United States. In the Phase 2a trial segment, 10 patients with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment).

关于Ibezapolstat第2期临床试验
完成了多中心、开放标签的单臂段(2a期)研究,随后是在28个美国临床试验中心开展的双盲、随机、主动对照、非劣效性段(2b期)研究,这些共同构成了2期临床试验。
(参见该2期临床试验的设计旨在评估ibezapolstat在治疗CDI中的临床疗效,包括药代动力学和微生物组变化。来自美国的研究中心。在2a期试验分段中,有10名因患难辨梭菌引起腹泻的患者口服ibezapolstat 450毫克,每日两次,共10天。所有患者在28±2天内进行了复发观察。根据方案,在预计的20名2a期患者中的10名患者完成治疗后(治疗结束时100%感染被治愈)后。

In the Phase 2b trial segment, which was discontinued due to success, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind. The Company previously reported that the overall observed Clinical Cure rate in the combined Phase 2 trials in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population, who experienced Clinical Cure during treatment with ibezapolstat. Ibezapolstat was well-tolerated, with three patients each experiencing one mild adverse event assessed by the blinded investigator to be drug- related. All three events were gastrointestinal in nature and resolved without treatment.

在20亿期试验分段中,由于成功而停止的32名CDI患者被招募并以1:1的比例随机分配到两组,一组口服ibezapolstat 450毫克,每12小时一次,另一组口服万古霉素125毫克,每6小时一次,各自持续10天,并在治疗结束后的28±2天内进行CDI复发观察。两种治疗在外观、服药时间和胶囊数量上是相同的,以维持双盲。公司先前报告,在CDI患者中,组合第2期试验中的综合观察临床治愈率为96%(26名患者中的25名),其中包括在以ibezapolstat治疗期间在ModifiIntent to Treat Population中经历临床治愈的10名患者(100%),以及在20亿期Per Protocol Population中15名患者中的15名(94%)。经专家评估与药物相关的3名患者各自出现了一次轻度不良事件。所有三起事件都是消化道问题,且未经治疗即有所缓解。

There were no drug-related treatment withdrawals or no drug-related serious adverse events, or other safety findings of concern. In the Phase 2b vancomycin control arm, 14 out of 14 patients experienced Clinical Cure. The Company is confident that based on the pooled Phase 2 ibezapolstat Clinical Cure rate of 96% and the historical vancomycin cure rate of approximately 81% (Vancocin Prescribing Information, January 2021), we will demonstrate non-inferiority of ibezapolstat to vancomycin in Phase 3 trials in accordance with the applicable FDA Guidance for Industry (October 2022).

在第20亿临床试验的万古霉素对照组中,14名患者中的14名经历了临床治愈。公司有信心,基于汇总的第2期ibezapolstat临床治愈率为96%以及历史上万古霉素治愈率约为81%(Vancocin处方信息,2021年1月),我们将根据适用的FDA行业指南(2022年10月)在第3期试验中展示ibezapolstat优于万古霉素的非劣效性。

In the Phase 2 clinical trial (both trial segments), the Company also evaluated pharmacokinetics (PK) and microbiome changes and test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy. Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. Very importantly, emerging data show an increased concentration of secondary bile acids during and following ibezapolstat therapy which is known to correlate with colonization resistance against C. difficile. A decrease in primary bile acids and the favorable increase in the ratio of secondary-to-primary bile acids suggest that ibezapolstat may reduce the likelihood of CDI recurrence when compared to vancomycin. The company also recently reported positive extended clinical cure (ECC) data for ibezapolstat (IBZ), its lead antibiotic candidate, from the Company's recently completed Phase 2b clinical trial in patients with CDI. This exploratory endpoint showed that 12 patients who agreed to be followed up to three months following Clinical Cure of their infection, 5 of 5 IBZ patients experienced no recurrence of infection. In the vancomycin control arm of the trial, 7 of 7 patients experienced no recurrence of infection. ECC success is defined as a clinical cure at the TOC visit (i.e., at least 48 hours post EOT) and no recurrence of CDI within the 56 ± 2 days post EOT (ECC56) and 84 ± 2 days post EOT (ECC84) in patients who consented to extended observation. In the Phase 2b trial, 100% (5 of 5) of ibezapolstat-treated patients who agreed to observation for up to three months following Clinical Cure of CDI experienced no recurrence of infection. Furthermore, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients.

在第2期临床试验(两个试验阶段)中,公司还评估了药物动力学(PK)和微生物组变化,并测试抗复发微生物组特性,包括基线后α多样性和细菌丰度的变化,特别是健康肠道微生物门的放大,放大和厚壁链菌门物种,在治疗期间和治疗后。第2a期数据表明,在ibezapolstat治疗的第三天,结肠C. difficile完全根除,同时观察到健康肠道微生物门,放大和厚壁链菌门物种,在治疗期间和治疗后。非常重要的是,新出现的数据显示,在ibezapolstat治疗期间和随后增加了次级胆酸的浓度,这已知与抗C. difficile的菌株耐受力相关。原生胆酸的减少以及次级到原生胆酸比值的有利增加提示,与万古霉素相比,ibezapolstat可能降低CDI复发的可能性。该公司最近还报道了ibezapolstat(IBZ)的正面扩展性临床治愈(ECC)数据,这是公司最近在CDI患者中进行的II期20亿临床试验中的首选抗生素候选药物。这一探索性终点显示,在感染得到临床治愈并同意在感染后三个月内进行随访的12名患者中,5名IBZ患者未发生感染复发。在试验的凡可霉素对照组中,7名患者未发生感染复发。ECC成功被定义为TOC访查时的临床治愈(即结束疗程的至少48小时)以及接受Extended Observation的患者在结束疗程后56 ± 2天(ECC56)和84 ± 2天(ECC84)内CDI未复发。在II期20亿试验中,接受观察的ibezapolstat治疗患者(5名中的5名)在CDI临床治愈后同意进行长达三个月的随访,未发生感染复发。此外,ibezapolstat治疗患者显示出较低的粪便原生胆酸浓度,以及比万古霉素治疗患者更高的有益次级到原生胆酸比值。

About Ibezapolstat
Ibezapolstat is the Company's lead antibiotic candidate planning to advance to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). Ibezapolstat is a novel, orally administered antibiotic, being developed as a Gram-Positive Selective Spectrum (GPSS) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome.

关于Ibezapolstat
Ibezapolstat是公司的首选抗生素候选药物,计划进入国际第3期临床试验阶段,用于治疗C.difficile感染(CDI)患者。 Ibezapolstat是一种新型口服抗生素,正在研发作为革兰氏阳性选择性谱(GPSS)抗菌药物。它是Acurx公司研发用于治疗细菌感染的新一类DNA聚合酶IIIC抑制剂之一。Ibezapolstat独特的活性谱范围,包括C.difficile,但避免其他厚壁菌门和重要的放线菌门,似乎有助于保持健康的肠道微生物组。

In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

2018年6月,ibezapolstat被美国食品药物监督管理局(FDA)指定为治疗CDI患者的合格传染病产品(QIDP),将有资格从《现在生成新抗生素刺激法案(GAIN)》下开发新抗生素的激励措施中受益。2019年1月,FDA为ibezapolstat治疗CDI患者授予了"快速通道"(Fast Track)指定。疾病控制与预防中心(CDC)已将C. difficile确定为迫在眉睫的威胁,突显了治疗CDI所需新抗生素的重要性。

About Clostridioides difficile Infection (CDI)
According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of health care- associated infections in U.S. hospitals (Lessa, et al, 2015, New England Journal of Medicine). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 20,000 deaths annually. (Guh, 2020, New England Journal of Medicine). Based on internal estimates, the recurrence rate for the antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%.

关于Clostridioides difficile感染(CDI)
根据美国传染病学会(IDSA)和美国医疗保健流行病学会(SHEA)于2018年2月发布的2017年更新版《C.difficile感染临床实践指南》,CDI在医院、长期护理设施和社区中仍然是一个重大医学问题。 C.difficile是美国医院中与健康护理相关感染最常见的原因之一(Lessa等人,2015年,新英格兰医学杂志)。最近的估计表明,C.difficile每年在美国引起大约50万例感染,年与约2万例死亡相关(Guh,2020年,新英格兰医学杂志)。根据内部估计,目前用于治疗CDI的抗生素的复发率在约15万名接受治疗的患者中为20%至40%。我们认为,美国每年CDI的发病率接近60万例感染,死亡率约为9.3%。

About the Microbiome in C. difficile Infection (CDI) and Bile Acid Metabolism
C. difficile can be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020, 8, 200; doi:10.3390/microorganisms8020200.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa. Bile acids perform many functional roles in the GI tract, with one of the most important being maintenance of a healthy microbiome by inhibiting C. difficile growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C. difficile sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was observed in the Company's Ph2a trial results and previously reported (CID, 2022). In the Ph2b trial, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients.

关于C. difficile感染(CDI)和胆汁酸代谢中的微生物组
艰难梭菌可能是健康肠道微生物组的正常组成部分,但当微生物组失衡时,艰难梭菌可能会获得优势并引发感染。感染艰难梭菌后,该微生物会产生和释放主要毒力因子,两种大型梭菌毒素A(TcdA)和b(TcdB)。TcdA和Tcdb是外毒素,能结合到人类肠道上皮细胞并导致炎症、液体和粘液分泌,以及对肠粘膜的损害。胆汁酸在胃肠道中扮演着许多功能作用,其中一项重要的作用是通过抑制艰难梭菌的生长来维持健康的微生物组。由肝脏分泌到肠道的初级胆汁酸可以促进艰难梭菌孢子的萌发,从而增加在初次成功治疗之后再发CDI的风险。另一方面,由正常肠道微生物代谢初级胆汁酸产生的次级胆汁酸不会诱导艰难梭菌形成孢子,因此可以预防复发疾病。由于伊贝扎帕尔斯塔特治疗几乎不会对肠道微生物组造成破坏,细菌产生次级胆汁酸仍然延续,这可能有助于抗复发效果的产生。胆汁酸的益处包括减少CDI患者的原发性胆汁酸,以及促进次级胆汁酸的增加,这一现象在公司的Ph2a试验结果及之前的报道中有所观察(CID,2022年)。在第20亿试验中,伊贝扎帕尔斯塔特治疗的患者显示出比万古霉素治疗的患者更低的粪便原发性胆汁酸浓度,以及次级到原发性胆汁酸的有益比例更高。

About Acurx Pharmaceuticals, Inc.
Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS) that blocks the active site of the Gram-positive specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram- positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP). To learn more about Acurx Pharmaceuticals and its product pipeline, please visit .

关于Acurx Pharmaceuticals, Inc.
Acurx制药是一家专注于开发新型小分子抗生素用于难治性细菌感染的后期生物制药公司。该公司的方法是开发具有革兰阳性选择谱(GPSS)的抗生素候选药物,这些药物能阻断革兰阳性特异性细菌酶DNA聚合酶IIIC(pol IIIC)的活性位点,抑制DNA复制并导致革兰阳性细菌细胞死亡。其研发管线包括针对革兰阳性细菌的抗生素产品候选药物,包括艰难梭菌,耐甲氧西林的金黄色葡萄球菌(MRSA),耐万古霉素的肠球菌(VRE)和耐药肺炎链球菌(DRSP)。要了解更多关于Acurx制药及其产品管线的信息,请访问 .

Forward-Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the year ended December 31, 2023, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward- looking statements speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.

前瞻性声明
关于我们未来期望、计划和前景的任何声明,包括关于我们的策略、未来业务、前景、计划和目标的声明以及包含"相信"、"预期"、"计划"、"期望"和类似表达的其他声明,构成根据1995年《证券诉讼改革法》的前瞻性声明。实际结果可能因各种重要因素出现重大差异,包括:ibezapolstat是否将受益于QIDP指定;ibezapolstat是否将及时穿越临床试验流程;ibezapolstat的临床试验结果是否将支持提交营销批准申请,如果是,ibezapolstat是否将获得FDA或其它寻求批准的外国监管机构批准;如果ibezapolstat获得批准,是否将成功分销和推广;以及公司就描述2023年12月31日结束的年度报告在美国证券交易委员会提交的10-k表格以及后续提交给美国证券交易委员会的文件中描述的其他风险和不确定性。此类前瞻性声明仅代表本新闻稿刊发之日,并且Acurx不承诺更新这些前瞻性声明以反映这些声明日期之后的事件或情况,除非法律要求。

Investor Contact:
Acurx Pharmaceuticals, Inc.
David P. Luci, President & CEO
Tel: 917-533-1469
Email: [email protected]

投资者联系人:
Acurx Pharmaceuticals, Inc.
David P. Luci,总裁兼首席执行官
电话:917-533-1469
邮箱: [email protected]

SOURCE Acurx Pharmaceuticals, Inc.

资讯来源:Acurx制药公司

WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM?

想要您公司的新闻在PRNEWSWIRE.COM上特色呈现吗?

440k+
440k+

Newsrooms &
新闻发布室&

Influencers
影响力人士
9k+
9k+

Digital Media
数字媒体

Outlets
Outlets
270k+
270k+

Journalists
记者

Opted In
Opted In
GET STARTED
开始使用
声明:本内容仅用作提供资讯及教育之目的,不构成对任何特定投资或投资策略的推荐或认可。 更多信息
    抢沙发