Acurx Updates Phase 3 Readiness for Ibezapolstat in C. difficile Infection Based on Recent FDA and EMA Communications
Acurx Pharmaceuticals has provided updates on the Phase 3 readiness of its lead antibiotic candidate, ibezapolstat, for treating C. difficile Infection (CDI). The FDA has given positive feedback on the proposed Chemistry Manufacturing and Controls (CMC) plan, and Acurx is awaiting final advice from the European Medicines Agency (EMA) for the Phase 3 clinical program in the EU. The company is also discussing pediatric development plans with both the FDA and EU authorities. Acurx is preparing to request regulatory guidance for initiating clinical trials in Japan, Canada, and the UK.
Phase 3 international trial planning is advancing, utilizing AI to identify optimal clinical trial sites. Ibezapolstat has previously received FDA QIDP and Fast-Track Designation and SME designation from the EMA. The Phase 3 trial will involve approximately 450 subjects, comparing ibezapolstat to vancomycin, with a focus on achieving clinical cure and reducing CDI recurrence. The Executive Chairman expressed confidence in the trial's success, which would pave the way for US NDA submission and EU Marketing Authorization.
Acurx Pharmaceuticals ha fornito aggiornamenti sulla prontezza della Fase 3 del suo principale candidato antibiotico, ibezapolstat, per il trattamento dell'infezione da C. difficile (CDI). La FDA ha fornito feedback positivi sul piano proposto di Chimica, Produzione e Controlli (CMC), e Acurx sta aspettando ulteriori consigli dall'Agenzia Europea dei Medicinali (EMA) per il programma clinico di Fase 3 nell'UE. L'azienda sta anche discutendo piani di sviluppo pediatrico con le autorit脿 della FDA e dell'UE. Acurx si sta preparando a richiedere indicazioni regolatorie per avviare studi clinici in Giappone, Canada e Regno Unito.
La pianificazione della sperimentazione internazionale di Fase 3 sta procedendo, sfruttando l'IA per identificare i siti ottimali per le prove cliniche. Ibezapolstat ha ricevuto in precedenza la designazione QIDP e Fast-Track dalla FDA e la designazione SME dall'EMA. La sperimentazione di Fase 3 coinvolger脿 circa 450 soggetti, confrontando ibezapolstat con la vancomicina, con un focus sul raggiungimento della cura clinica e sulla riduzione della ricorrenza della CDI. Il presidente esecutivo ha espresso fiducia nel successo della sperimentazione, che aprirebbe la strada per la sottomissione del NDA negli USA e per l'autorizzazione al commercio nell'UE.
Acurx Pharmaceuticals ha proporcionado actualizaciones sobre la preparaci贸n para la Fase 3 de su principal candidato a antibi贸tico, ibezapolstat, para el tratamiento de la infecci贸n por C. difficile (CDI). La FDA ha dado comentarios positivos sobre el plan propuesto de Qu铆mica, Fabricaci贸n y Controles (CMC), y Acurx est谩 esperando el consejo final de la Agencia Europea de Medicamentos (EMA) para el programa cl铆nico de Fase 3 en la UE. La compa帽铆a tambi茅n est谩 discutiendo planes de desarrollo pedi谩trico con las autoridades de la FDA y la UE. Acurx se est谩 preparando para solicitar orientaci贸n regulatoria para iniciar ensayos cl铆nicos en Jap贸n, Canad谩 y el Reino Unido.
La planificaci贸n del ensayo internacional de Fase 3 est谩 avanzando, utilizando inteligencia artificial para identificar los sitios 贸ptimos para los ensayos cl铆nicos. Ibezapolstat hab铆a recibido anteriormente las designaciones QIDP y Fast-Track de la FDA y la designaci贸n SME de la EMA. El ensayo de Fase 3 involucrar谩 aproximadamente a 450 sujetos, comparando ibezapolstat con vancomicina, con un enfoque en lograr la cura cl铆nica y reducir la recurrencia de la CDI. El presidente ejecutivo expres贸 confianza en el 茅xito del ensayo, lo que allanar铆a el camino para la presentaci贸n de la NDA en EE. UU. y la autorizaci贸n de marketing en la UE.
Acurx Pharmaceuticals電� ibezapolstat鞚� 3靸� 欷�牍� 靸來儨鞐� 雽�頃� 鞐呺嵃鞚错姼毳� 鞝滉车頄堨姷雼堧嫟. 鞚� 鞝滍拡鞚� C. difficile 臧愳椉(CDI) 旃橂毳� 鞙勴暅 欤检殧 頃儩鞝� 頉勲炒鞛呺媹雼�. FDA電� 鞝滌晥霅� 頇旐暀, 鞝滌“ 氚� 頀堨 甏�毽�(CMC) 瓿勴殟鞐� 雽�頃� 旮嶌爼鞝侅澑 頂茧摐氚膘潉 欤检棃鞙茧┌, Acurx電� EU 雮� 3靸� 鞛勳儊 頂勲攴鸽灗鞐� 雽�頃� 斓滌 臁办柛鞚� 鞙犽熃 鞚橃暯頀堨箔(EMA)鞐愳劀 旮半嫟毽碃 鞛堨姷雼堧嫟. 鞚� 須岇偓電� 霕愴暅 FDA 氚� EU 雼龟淡瓿� 頃粯 靻岇晞 臧滊皽 瓿勴殟鞐� 雽�頃� 雲检潣頃橁碃 鞛堨姷雼堧嫟. Acurx電� 鞚茧掣, 旌愲倶雼� 氚� 鞓侁淡鞐愳劀 鞛勳儊 鞁滍棙鞚� 鞁滌瀾頃橁赴 鞙勴暅 攴滌牅 歆�旃� 鞖旍箔鞚� 欷�牍勴晿瓿� 鞛堨姷雼堧嫟.
3靸� 甑牅 鞛勳儊 鞁滍棙 瓿勴殟鞚� 斓滌爜鞚� 鞁滍棙 靷澊韸鸽ゼ 頇曥澑頃橁赴 鞙勴暣 AI毳� 頇滌毄頃橃棳 歆勴枆霅橁碃 鞛堨姷雼堧嫟. Ibezapolstat電� 鞚挫爠鞐� FDA搿滊秬韯� QIDP 氚� 瓿犾啀 觳橂Μ 歆�鞝�, 攴鸽Μ瓿� EMA搿滊秬韯� SME 歆�鞝曥潉 氚涭晿鞀惦媹雼�. 3靸� 鞛勳儊 鞁滍棙鞚� 鞎� 450氇呾潣 頂柬棙鞛愲ゼ 韽暔頃橃棳 ibezapolstat瓿� 氚橃綌毵堨澊鞁犾潉 牍勱祼頃橂┌, 鞛勳儊鞝� 旃橂 雼劚瓿� CDI 鞛皽 臧愳唽鞐� 欷戩爯鞚� 霊愱碃 歆勴枆霅╇媹雼�. 須岇灔歆侅潃 鞁滍棙鞚� 靹标车鞐� 雽�頃� 鞁犽毳� 響滊獏頃橂┌, 鞚措姅 氙戈淡 NDA 鞝滌稖 氚� EU 毵堨紑韺� 項堦皜毳� 鞙勴暅 旮胳潉 鞐� 瓴冹澊霛缄碃 氚濏様鞀惦媹雼�.
Acurx Pharmaceuticals a fourni des mises 脿 jour sur la pr茅paration de la phase 3 de son principal candidat antibiotique, ibezapolstat, pour le traitement de l'infection 脿 C. difficile (CDI). La FDA a donn茅 des retours positifs sur le plan propos茅 de Chimie, Fabrication et Contr么les (CMC), et Acurx attend des conseils finaux de l'Agence Europ茅enne des M茅dicaments (EMA) pour le programme clinique de la phase 3 dans l'UE. La soci茅t茅 discute 茅galement des plans de d茅veloppement p茅diatrique avec les autorit茅s de la FDA et de l'UE. Acurx se pr茅pare 脿 demander des orientations r茅glementaires pour initier des essais cliniques au Japon, au Canada et au Royaume-Uni.
La planification de l'essai international de phase 3 progresse, utilisant l'IA pour identifier les sites d'essai cliniques optimaux. Ibezapolstat a pr茅c茅demment re莽u la d茅signation QIDP et Fast-Track de la FDA ainsi que la d茅signation SME de l'EMA. L'essai de phase 3 impliquera environ 450 sujets, comparant ibezapolstat 脿 la vancomycine, avec un accent sur l'obtention d'une gu茅rison clinique et la r茅duction de la r茅cidive de la CDI. Le pr茅sident ex茅cutif a exprim茅 sa confiance dans le succ猫s de l'essai, qui ouvrirait la voie 脿 la soumission de la NDA aux 脡tats-Unis et 脿 l'autorisation de mise sur le march茅 en UE.
Acurx Pharmaceuticals hat Updates zur Bereitstellung der Phase 3 f眉r seinen Hauptkandidaten Antibiotikum ibezapolstat zur Behandlung der C. difficile-Infektion (CDI) bereitgestellt. Die FDA hat positives 黑料网back zum vorgeschlagenen Plan f眉r Chemie, Herstellung und Kontrollen (CMC) gegeben, und Acurx wartet auf endg眉ltige Hinweise von der Europ盲ischen Arzneimittel-Agentur (EMA) f眉r das klinische Programm der Phase 3 in der EU. Das Unternehmen diskutiert auch p盲diatrische Entwicklungspl盲ne mit den Beh枚rden der FDA und der EU. Acurx bereitet sich darauf vor, regulatorische Leitlinien f眉r die Einleitung klinischer Studien in Japan, Kanada und dem Vereinigten K枚nigreich anzufordern.
Die Planung der internationalen Phase-3-Studie schreitet voran, wobei KI genutzt wird, um optimale klinische Pr眉fstellen zu identifizieren. Ibezapolstat hat zuvor die QIDP- und Fast-Track-Zulassung von der FDA sowie die SME-Zulassung der EMA erhalten. Die Phase-3-Studie wird etwa 450 Probanden umfassen, die ibezapolstat mit Vancomycin vergleichen, wobei der Schwerpunkt auf der Erreichung einer klinischen Heilung und der Verringerung der CDI-Wiederholung liegt. Der Vorsitzende 盲u脽erte Vertrauen in den Erfolg der Studie, die den Weg f眉r die NDA-Einreichung in den USA und die Marktzulassung in der EU ebnen w眉rde.
- FDA positive feedback on CMC plan.
- Advancing Phase 3 trial planning using AI.
- Awaiting final EMA advice for Phase 3 in the EU.
- Preparing regulatory guidance requests for trials in Japan, Canada, and the UK.
- Ibezapolstat received FDA QIDP and Fast-Track Designation.
- Ibezapolstat received SME designation from EMA.
- No final written advice from EMA yet.
Insights
The FDA and EMA communications represent significant regulatory progress for ibezapolstat. The positive feedback on CMC and agreement on Phase 3 trial design demonstrates strong clinical development positioning. The planned 450-patient Phase 3 trial with modified intent-to-treat analysis aligns with both FDA and EMA requirements, streamlining the path to potential dual market approvals.
The trial's dual-purpose design to evaluate both clinical cure and recurrence reduction is strategically important, as CDI recurrence remains a major clinical challenge. The potential for superiority testing against vancomycin, if non-inferiority is demonstrated, could provide a compelling competitive advantage in the
The QIDP and Fast-Track designations, combined with EMA's SME benefits, suggest an expedited regulatory pathway with reduced costs - important for a company with
The regulatory strategy demonstrates sophisticated planning with synchronized FDA/EMA approaches. The written communications format indicates strong preliminary data and submissions, as agencies typically reserve this efficient response method for well-prepared applications. The agreement on mITT population analysis shows careful consideration of both US and EU requirements, potentially avoiding costly protocol amendments.
The expansion into Japan, Canada and UK markets through additional regulatory consultations suggests a comprehensive global strategy. The pediatric development planning aligns with regulatory requirements for both markets, potentially expanding the drug's eventual commercial reach. The SME designation provides valuable fee reductions and regulatory support, optimizing development resources.
- Following the previously announced successful End of Phase 2 Meeting achieving agreement with FDA on non-clinical and clinical Phase 3-readiness, Acurx has now also received written positive feedback from FDA regarding acceptability of our CMC (Chemistry Manufacturing and Controls) plan and data package proposed to support the Phase 3 clinical program
- Acurx has initiated the Scientific Advice procedure with the European Medicines Agency (EMA) to discuss the readiness for initiation of the Phase 3 clinical program in the European Union (EU). Acurx has been notified that we should expect to receive the final written advice letter in the coming few weeks
- Acurx is also in the process of discussing the pediatric development plans for ibezapolstat in C. difficile Infection with FDA and EU health authorities, per regulatory requirements.
- Phase 3 international trial planning continues to advance, using AI and other state-of-the-art techniques to identify and qualify clinical trial sites with the highest potential for patient enrollment
- Acurx is also preparing to request regulatory guidance to initiate clinical trials in
Japan ,Canada and theUnited Kingdom - Ibezapolstat has previously been granted FDA QIDP and Fast-Track Designation from FDA and Acurx has received SME (Small and Medium-sized Enterprise) designation by the EMA to benefit from fee incentives and other support from the EMA for EU Marketing Authorization
Written communications are used by both regulatory agencies in lieu of face-to-face or teleconference/video conferences when these agencies determine that a written response to the sponsor's questions would be the most appropriate means for providing feedback and advice to the sponsor. (, )
Acurx's听Executive听Chairman,听Bob听DeLuccia,听stated: "We are very pleased with these latest favorable communications from both regulatory agencies and in our opinion are a testament to the strength of our clinical data to date, our robust regulatory submissions, and adherence to current regulatory guidance." He further added: "We anticipate, and are confident, that with final EMA advice for our ibezapolstat Phase 3 trials for adult patients with CDI and the pediatric development plans from both regulatory agencies, Acurx will have a clear international roadmap for conduct of our Phase 3 program and, if successful, requirements for US NDA submission and EU Marketing Authorization."
Acurx has previously announced that it had a successful FDA End-of-Phase 2 Meeting and Phase 3 Readiness for ibezapolstat听for听the听Treatment of 颁.听诲颈蹿蹿颈肠颈濒别 Infection.听Agreement with FDA was reached on key elements to move forward with its international Phase 3 clinical听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听Infection (CDI). Acurx is also preparing to submit requests for regulatory guidance to initiate clinical trials in the European Union, to be followed by听requests to be submitted in the
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听EMA Scientific Advice Meeting, the primary efficacy analysis will be performed using a Modified Intent-To-reat (mITT)听population听consistent听with听EMA听requirements.听This听will听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.
础产辞耻迟听the听Ibezapolstat Phase 2听Clinical听Trial
The completed听multicenter,听open-label听single-arm听segment听(Phase听2a)听study听was听followed by听a听double-blind,听randomized,听active-controlled,听non-inferiority,听segment (Phase听2b)听at 28 US clinical trial sites which together comprise the Phase 2 clinical trial. () This Phase 2 clinical trial was designed to evaluate the clinical efficacy of听ibezapolstat in the treatment of CDI including pharmacokinetics听and microbiome听changes from听baseline.听from听study听centers in听the听United States. In the Phase 2a trial segment,10 patients with diarrhea caused by C. difficile听were treated with ibezapolstat听450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28卤 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (
In听the听Phase听2b听trial听segment, which听was听discontinued听due听to听success, 32听patients听with听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 卤 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
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听control听arm,听14听out of 14 patients experienced Clinical Cure. The Company is confident that based on the pooled Phase 2 ibezapolstat Clinical Cure rate of
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听Actinobacteria听and听Firmicute听phylum听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听control arm of the trial, 7 of 7 patients experienced no recurrence of infection.听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 卤 2 days post EOT (ECC56) and 84 卤 2 days post EOT (ECC84) in patients who consented to extended observation. In the Phase 2b trial,
础产辞耻迟听滨产别锄补辫辞濒蝉迟补迟
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庐) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx听to treat bacterial infections. Ibezapolstat's听unique spectrum听of听activity, which includes C. difficile but spares other Firmicutes听and the important Actinobacteria听phyla, appears to contribute to the maintenance of a healthy gut听microbiome.
In June 2018, ibezapolstat was designated by the
础产辞耻迟听颁濒辞蝉迟谤颈诲颈辞颈诲别蝉听诲颈蹿蹿颈肠颈濒别听滨苍蹿别肠迟颈辞苍听(颁顿滨)
According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile听Infection by the Infectious Diseases Society of America (IDSA) and听Society听or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community.听C. difficile听is one of the most common causes of health care- associated infections in
础产辞耻迟听the听Microbiome听in听颁.听诲颈蹿蹿颈肠颈濒别听滨苍蹿别肠迟颈辞苍听(颁顿滨) and Bile Acid Metabolism
C. difficile听can be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the听C. difficile听can thrive and cause an infection. After colonization听with 颁.听诲颈蹿蹿颈肠颈濒别, the organism produces and releases the main virulence factors, the two large听clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020, 8, 200; doi: 0.3390/microorganisms8020200.) TcdA听and TcdB听are exotoxins听that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal听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听growth. Primary bile acids, which听are听secreted听by听the听liver听into听the听intestines,听promote germination听of听颁.听诲颈蹿蹿颈肠颈濒别听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听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听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听vancomycin-treated patients.
础产辞耻迟听Acurx Pharmaceuticals,听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庐) 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听cell听death.听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), drug-resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen).听 Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection is Phase 3 ready with plans in progress to begin international clinical trials next year. The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel.
To learn more about Acurx Pharmaceuticals and its product pipeline, please visit .
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听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听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.
Investor Contact:
Acurx Pharmaceuticals, Inc.
David P.听Luci, President & CEO
Tel: 917-533-1469
贰尘补颈濒:听davidluci@acurxpharma.com
听
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SOURCE Acurx Pharmaceuticals, Inc.
FAQ
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