JPO Grants Acurx Pharmaceuticals Patent in Japan for DNA Polymerase IIIC Inhibitors
Acurx Pharmaceuticals (NASDAQ: ACXP) has been granted a new patent by the Japanese Patent Office in January 2025 for DNA Polymerase IIIC Inhibitors, covering compositions-of-matter, surface coatings, and pharmaceutical compositions for treating Gram-positive bacterial infections. This adds to their existing portfolio of three U.S. patents, one Israeli patent, and additional pending applications.
The company has received positive regulatory guidance from the EMA for its Phase 3-ready ibezapolstat program, designed to treat and prevent recurrence of C. difficile Infection. The EMA's Scientific Advice Procedure confirmed that Acurx's clinical, non-clinical, and CMC package supports advancement to Phase 3 trials and potential MAA submission in Europe.
The planned Phase 3 program consists of two international trials comparing ibezapolstat to vancomycin, with 450 subjects in the Modified Intent-To-Treat population for the initial trial. The study will evaluate both Clinical Cure of CDI and potential reduction in recurrence rates.
Acurx Pharmaceuticals (NASDAQ: ACXP) ha ottenuto un nuovo brevetto dall'Ufficio Giapponese dei Brevetti nel gennaio 2025 per gli inibitori della DNA Polimerasi IIIC, che copre composizioni di materia, rivestimenti superficiali e composizioni farmaceutiche per il trattamento delle infezioni batteriche Gram-positive. Questo si aggiunge al loro portafoglio esistente di tre brevetti statunitensi, un brevetto israeliano e ulteriori domande pendenti.
L'azienda ha ricevuto indicazioni normative positive dall'EMA per il suo programma ibezapolstat, pronto per la Fase 3, progettato per trattare e prevenire la ricorrenza dell'infezione da C. difficile. La Procedura di Consiglio Scientifico dell'EMA ha confermato che il pacchetto clinico, non clinico e CMC di Acurx supporta l'avanzamento verso la Fase 3 e la potenziale presentazione della domanda di autorizzazione all'immissione in commercio in Europa.
Il programma della Fase 3 pianificato consiste in due studi internazionali che confrontano ibezapolstat con la vancomicina, con 450 soggetti nella popolazione modificata per l'intento di trattare per lo studio iniziale. Lo studio valuterà sia la cura clinica dell'infezione da CDI sia la potenziale riduzione dei tassi di ricorrenza.
Acurx Pharmaceuticals (NASDAQ: ACXP) ha recibido una nueva patente de la Oficina de Patentes de Japón en enero de 2025 para los inhibidores de la DNA Polimerasa IIIC, que cubre composiciones de materia, recubrimientos superficiales y composiciones farmacéuticas para el tratamiento de infecciones bacterianas Gram-positivas. Esto se suma a su cartera existente de tres patentes en EE. UU., una patente israelí y solicitudes adicionales pendientes.
La compañía ha recibido orientación regulatoria positiva de la EMA para su programa ibezapolstat, listo para la Fase 3, diseñado para tratar y prevenir la recurrencia de la infección por C. difficile. El Procedimiento de Asesoramiento Científico de la EMA confirmó que el paquete clínico, no clínico y CMC de Acurx apoya el avance a los ensayos de Fase 3 y la posible presentación de la solicitud de autorización de comercialización en Europa.
El programa de Fase 3 planeado consta de dos ensayos internacionales que comparan ibezapolstat con vancomicina, con 450 sujetos en la población de Intención de Trato Modificada para el ensayo inicial. El estudio evaluará tanto la Curación Clínica de la CDI como la posible reducción en las tasas de recurrencia.
Acurx Pharmaceuticals (NASDAQ: ACXP)는 2025년 1월 일본 특허청에서 DNA 폴리메라제 IIIC 억제제에 대한 새로운 특허를 부여받았으며, 여기에는 물질 조성, 표면 코팅 및 그람 양성 박테리아 감염 치료를 위한 제약 조성이 포함됩니다. 이는 미국에서의 세 개의 특허, 이스라엘 특허 및 추가 대기 중인 신청서와 함께 그들의 기존 포트폴리오에 추가됩니다.
회사는 C. difficile 감염의 치료 및 재발 예방을 위해 설계된 Fase 3 준비가 완료된 ibezapolstat 프로그램에 대해 EMA로부터 긍정적인 규제 지침을 받았습니다. EMA의 과학적 조언 절차는 Acurx의 임상, 비임상 및 CMC 패키지가 Fase 3 시험으로의 진전을 지원하고 유럽 내 MAA 제출 가능성을 확인했습니다.
계획된 Fase 3 프로그램은 ibezapolstat와 반코마이신을 비교하는 두 개의 국제 시험으로 구성되어 있으며, 초기 시험에 대해 수정된 의도 치료(population)에서 450명의 피험자가 포함됩니다. 이 연구는 CDI의 임상 치료와 재발률 감소 가능성을 평가할 것입니다.
Acurx Pharmaceuticals (NASDAQ: ACXP) a obtenu un nouveau brevet de l'Office japonais des brevets en janvier 2025 pour des inhibiteurs de la DNA polymérase IIIC, couvrant des compositions de matière, des revêtements de surface et des compositions pharmaceutiques pour traiter les infections bactériennes Gram-positives. Cela s'ajoute à leur portefeuille existant de trois brevets américains, un brevet israélien et d'autres demandes en attente.
L'entreprise a reçu des conseils réglementaires positifs de l'EMA pour son programme ibezapolstat, prêt pour la phase 3, conçu pour traiter et prévenir la récurrence de l'infection à C. difficile. La procédure de conseil scientifique de l'EMA a confirmé que le paquet clinique, non clinique et CMC d'Acurx soutient l'avancement vers les essais de phase 3 et la soumission potentielle d'une demande d'autorisation de mise sur le marché en Europe.
Le programme de phase 3 prévu se compose de deux essais internationaux comparant ibezapolstat à la vancomycine, avec 450 sujets dans la population modifiée pour l'intention de traiter pour l'essai initial. L'étude évaluera à la fois la guérison clinique de la CDI et la réduction potentielle des taux de récidive.
Acurx Pharmaceuticals (NASDAQ: ACXP) hat im Januar 2025 ein neues Patent vom Japanischen Patentamt für DNA-Polymerase-IIIC-Inhibitoren erhalten, das Zusammensetzungen, Oberflächenbeschichtungen und pharmazeutische Zusammensetzungen zur Behandlung von grampositiven bakteriellen Infektionen abdeckt. Dies ergänzt ihr bestehendes Portfolio von drei US-Patenten, einem israelischen Patent und weiteren ausstehenden Anträgen.
Das Unternehmen hat positive regulatorische Hinweise von der EMA für sein Phase-3-bereites Ibezapolstat-Programm erhalten, das zur Behandlung und Verhinderung von Rückfällen bei C. difficile-Infektionen entwickelt wurde. Das wissenschaftliche Beratungsverfahren der EMA bestätigte, dass das klinische, nicht-klinische und CMC-Paket von Acurx den Fortschritt zu Phase-3-Studien und die potenzielle Einreichung eines MAA in Europa unterstützt.
Das geplante Phase-3-Programm besteht aus zwei internationalen Studien, die Ibezapolstat mit Vancomycin vergleichen, mit 450 Probanden in der modifizierten Intent-to-Treat-Population für die erste Studie. Die Studie wird sowohl die klinische Heilung von CDI als auch die mögliche Reduzierung der Rückfallraten bewerten.
- Secured new Japanese patent for DNA Polymerase IIIC Inhibitors
- Received EMA approval to advance ibezapolstat to Phase 3 trials
- Obtained regulatory support for potential European market authorization
- None.
Insights
The newly granted Japanese patent significantly strengthens Acurx's global intellectual property position for their DNA Polymerase IIIC Inhibitors platform. This is particularly strategic as Japan represents the world's third-largest pharmaceutical market, providing important protection for future commercialization opportunities. The patent's broad scope, covering compositions-of-matter and pharmaceutical compositions, creates substantial barriers to entry for potential competitors.
The timing is especially significant as it coincides with Acurx's advancement of ibezapolstat into Phase 3 trials. The company has achieved a important milestone by securing aligned regulatory guidance from both the FDA and EMA, which substantially de-risks their development pathway. The planned Phase 3 program, with its robust design of two international trials targeting 450 subjects, demonstrates a well-thought-out strategy to prove non-inferiority against vancomycin, with the potential to demonstrate superiority.
The company's AI-supported drug discovery platform for second-generation DNA pol IIIC inhibitors, combined with this expanded patent protection, positions Acurx to address critical medical needs in treating resistant Gram-positive infections, including MRSA and anthrax. This represents a significant market opportunity, particularly given the growing global concern over antibiotic resistance and the pipeline of new antibiotics in development.
Robert J. DeLuccia, Executive Chairman of Acurx, stated: "Complementing our global patent estate with minimally absorbed oral ibezapolstat, now Phase 3-ready for the treatment and prevention of recurrence of C. difficile Infection, this patent, with others to follow, is very important and timely as we further develop our innovative, AI-supported drug discovery platform of second-generation DNA pol IIIC inhibitors. He added: "Other compounds in our program are systemically absorbed for potential oral and parenteral use in multiple clinical settings for treatment of infections caused by other gram-positive bacteria, such as Staphylococcus aureus, including MRSA and B. anthracis or anthrax; a Bioterrorism Category A Threat-Level pathogen."
Acurx previously announced that it had received positive regulatory guidance from the EMA during its Scientific Advice Procedure which confirmed that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted to EMA supports advancement of the ibezapolstat Phase 3 program and if the Phase 3 program is successful, supports the submission of a marketing authorization application (MAA) for regulatory approval in Europe. The information package submitted to EMA by the Company to which agreement has been reached with EMA included details on Acurx's two planned Phase 3 international, 1:1 randomized clinical trials (designed as non-inferiority trials vs vancomycin), primary and secondary endpoints, sample size, statistical analysis plan and the overall registration safety database. With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program.
The primary efficacy analysis will be performed using a Modified Intent-To-Treat (mITT) population. 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.
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. (Link to Clinicaltrials.gov/NCT042447542) 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
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
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,
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.
In June 2018, ibezapolstat was designated by the
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
New England Journal of Medicine). Recent estimates suggest C. difficile approaches 500,000 infections annually in the
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 the 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.
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), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). 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 the 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 www.acurxpharma.com.
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.
Investor Contact: Acurx Pharmaceuticals, Inc.
David P. Luci, President & CEO Tel: 917-533-1469
Email: davidluci@acurxpharma.com
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SOURCE Acurx Pharmaceuticals, Inc.
FAQ
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