CorMedix Announces Completion of Enrollment in Phase III ReSPECT Clinical Trial for REZZAYO
CorMedix (NASDAQ: CRMD) has announced the completion of enrollment in its Phase III ReSPECT clinical trial for REZZAYO® (rezafungin). The study evaluates REZZAYO as a prophylactic treatment against Candida, Aspergillus, and Pneumocystis infections in patients undergoing allogeneic blood and marrow transplantation.
The trial, sponsored by Mundipharma, compares once-weekly REZZAYO to standard antimicrobial treatment. The dosing regimen includes a 400 mg loading dose followed by 200 mg weekly for 13 weeks. Topline results are expected in Q2 2026. The study's primary endpoint is fungal-free survival at day 90, with secondary endpoints including IFD incidence, toxicity-related discontinuation, and mortality.
CorMedix (NASDAQ: CRMD) ha annunciato il completamento dell'arruolamento nello studio di fase III ReSPECT per REZZAYO® (rezafungin). Lo studio valuta REZZAYO come trattamento profilattico contro infezioni da Candida, Aspergillus e Pneumocystis nei pazienti sottoposti a trapianto allogenico di midollo osseo. Lo studio, sponsorizzato da Mundipharma, confronta REZZAYO somministrato una volta a settimana con il trattamento antimicrobico standard. Il regime posologico prevede un caricamento di 400 mg seguito da 200 mg settimanali per 13 settimane. I risultati principali sono attesi nel secondo trimestre del 2026. L'obiettivo primario dello studio è la sopravvivenza senza infezione fungina al giorno 90, con obiettivi secondari tra cui l'incidenza di infezioni fungine invasive (IFD), interruzioni legate alla tossicità e mortalità.
CorMedix (NASDAQ: CRMD) ha anunciado la finalización del reclutamiento en su ensayo de fase III ReSPECT para REZZAYO® (rezafungina). El estudio evalúa REZZAYO como tratamiento profiláctico contra infecciones por Candida, Aspergillus y Pneumocystis en pacientes sometidos a trasplante de médula ósea alogénico. El ensayo, patrocinado por Mundipharma, compara REZZAYO administrado semanalmente con el tratamiento antimicrobiano estándar. El régimen de dosificación contempla una dosis de carga de 400 mg seguida de 200 mg semanales durante 13 semanas. Se esperan resultados preliminares en el segundo trimestre de 2026. El objetivo primario es la supervivencia libre de infección fúngica al día 90, con objetivos secundarios que incluyen la incidencia de IFD, interrupciones por toxicidad y mortalidad.
CorMedix (나스닥: CRMD)가 REZZAYO®(rezafungin)에 대한 3상 ReSPECT 임상시험의 등록 완료를 발표했습니다. 이 연구는 동종 조혈모세포 이식 환자에서 Candida, Aspergillus 및 Pneumocystis 감염에 대한 예방적 치료로 REZZAYO를 평가합니다. Mundipharma가 스폰서이며, 주 1회 투여하는 REZZAYO를 표준 항균 치료와 비교합니다. 용량 규정은 400 mg 로딩 용량 후 매주 200 mg를 13주간 투여하는 방식입니다. 상위 결과는 2026년 2분기에 기대됩니다. 주요 평가지표는 90일 차의 진균 무생존이며, 보조 지표로는 침습성 진균 감염 발생률, 독성으로 인한 중단 및 사망이 포함됩니다.
CorMedix (NASDAQ: CRMD) a annoncé l'achèvement du recrutement de son essai de phase III ReSPECT pour REZZAYO® (rezafungine). L'étude évalue REZZAYO comme traitement prophylactique contre les infections à Candida, Aspergillus et Pneumocystis chez les patients recevant une transplantation de moelle osseuse allogénique. L'essai, sponsorisé par Mundipharma, compare REZZAYO administré une fois par semaine au traitement antimicrobien standard. Le schéma posologique prévoit une dose de chargement de 400 mg suivie de 200 mg par semaine pendant 13 semaines. Des résultats préliminaires sont attendus au 2e trimestre 2026. L'objectif primaire est la survie sans infection fongique au jour 90, avec des endpoints secondaires comprenant l'incidence d'IFD, les interruptions liées à la toxicité et la mortalité.
CorMedix (NASDAQ: CRMD) hat die Rekrutierung für die Phase-III-Studie ReSPECT zu REZZAYO® (Rezafungin) abgeschlossen. Die Studie bewertet REZZAYO als prophylaktische Behandlung gegen Candida-, Aspergillus- und Pneumocystis-Infektionen bei Patienten nach allogener Knochenmarktransplantation. Die Studie, von Mundipharma gesponsert, vergleicht REZZAYO, das einmal wöchentlich verabreicht wird, mit der Standardantimikrobielle-Therapie. Das Dosisregime umfasst eine 400 mg Lade-Dosis gefolgt von 200 mg wöchentlich über 13 Wochen. Die ersten Ergebnisse werden voraussichtlich im 2. Quartal 2026 erwartet. Primärer Endpunkt ist das fungi-freie Überleben am Tag 90; sekundäre Endpunkte umfassen die Inzidenz invasiver Pilzinfektionen (IFD), toxizitätsbedingte Abbrüche und Mortalität.
كورمدكس (المدرجة في بورصة ناسداك: CRMD) أعلنت إكمال التسجيل في تجربة المرحلة الثالثة ReSPECT لعقار REZZAYO® (ريزازونجين). تقيّم الدراسة REZZAYO كعلاج وقائي ضد عدوى كانديدا، الأسبرجيللس وإنتانات Pneumocystis لدى مرضى زرع نخاع عظمي متبرَع له جميعًا. الدراسة الممولة من Mundipharma تقارن REZZAYO المأنهول مرة أسبوعيًا بالعلاج المضاد للميكروبات القياسي. يشتمل regimen الجرعات على تحميل 400 ملغ يليه 200 ملغ أسبوعيًا لمدة 13 أسبوعًا. من المتوقع الحصول على النتائج الأولية في الربع الثاني من 2026. الهدف الأساسي للدراسة هو النجاة من دون فطريات عند اليوم 90، والغايات الثانوية تشمل معدل عدوى الفطريات الغازية، والفصل بسبب السمية، والوفيات.
CorMedix（纳斯达克：CRMD）宣布完成对 REZZAYO®（rezafungin）的 III 期 ReSPECT 临床试验的给药入组。该研究评估 REZZAYO 作为在异体造血干细胞移植患者中的预防性治疗，针对 念珠菌、曲霉菌和肺孢子菌感染。该研究由 Mundipharma 赞助，将每周给药的 REZZAYO 与标准抗微生物治疗进行比较。给药方案为 400 mg 加载剂量，随后每周 200 mg，持续 13 周。初步结果预计在 2026 年第 2 季公布。研究的主要终点是在第 90 天的真菌无存活率，次要终点包括侵袭性真菌感染（IFD）发生率、因毒性导致的中止以及死亡率。
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Insights
CorMedix completes enrollment for Phase III REZZAYO trial in transplant antifungal prophylaxis; topline results expected Q2 2026.
CorMedix has reached a significant clinical development milestone with the completion of enrollment in the Phase III ReSPECT trial for REZZAYO (rezafungin). This trial evaluates the drug as prophylaxis against invasive fungal diseases in patients undergoing allogeneic blood and marrow transplantation - a population at high risk for life-threatening fungal infections.
The trial design is particularly noteworthy for its once-weekly dosing regimen (400mg loading dose followed by 200mg weekly for 13 weeks), which represents a potential advantage over current standard antimicrobial regimens that typically require more frequent administration. The primary endpoint of fungal-free survival at day 90 directly addresses a critical clinical need in transplant medicine.
This enrollment completion keeps the company on track for topline results in Q2 2026, positioning REZZAYO for potential label expansion. REZZAYO is already commercially available for certain indications, but adding prophylaxis for BMT patients would significantly expand its market potential. The study's successful completion would address what CorMedix describes as a "critical unmet need" in this immunocompromised population where prevention of fungal infections is paramount to survival outcomes.
CorMedix's recent acquisition of Melinta Therapeutics (which held US distribution rights for REZZAYO) appears strategically timed to capture full commercial benefit should this trial yield positive results. This consolidation of rights ahead of potential label expansion suggests confidence in the trial outcome and commercial strategy.
- Enrollment Completed in Ongoing Phase III ReSPECT Study in Prophylaxis of Fungal Infections in Adult Patients Undergoing Allogeneic Blood and Marrow Transplant -
- Topline Results from ReSPECT Study Expected in 2Q 2026 -
BERKELEY HEIGHTS, N.J., Sept. 29, 2025 (GLOBE NEWSWIRE) -- CorMedix Inc. (“CorMedix”) (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced completion of enrollment for the ongoing, global Phase III ReSPECT trial evaluating the efficacy of REZZAYO® (rezafungin), a single-agent echinocandin in the prevention of Candida, Aspergillus, and Pneumocystis infection in patients undergoing allogeneic blood and marrow transplantation (BMT). This clinical trial has been sponsored by Mundipharma, located in the United Kingdom. The US distribution rights for REZZAYO were licensed under a strategic collaboration agreement with Melinta Therapeutics, LLC, a wholly owned subsidiary of CorMedix.
“Completing enrollment for the Phase III ReSPECT study represents an important step toward our goal of seeking FDA approval for REZZAYO in the prophylaxis of invasive fungal disease in adult patients receiving BMT,” said Joseph Todisco, CEO of CorMedix. Mr. Todisco continued, “While we have just recently closed our acquisition of Melinta Therapeutics, we believe that a prophylaxis indication for REZZAYO represents a significant growth opportunity for CorMedix, given the critical unmet need in this high-risk patient population. We look forward to sharing topline results from this study next year.”
The ReSPECT clinical trial is a Phase III, multicenter, randomized, double-blind study evaluating the efficacy and safety of once-weekly rezafungin (REZZAYO) versus a standard antimicrobial regimen (SAR) for the prevention of invasive fungal diseases (IFDs) in adults undergoing allogeneic BMT. Participants in the experimental arm receive a 400 mg loading dose of rezafungin in week one, followed by 200 mg weekly for 13 weeks, along with oral placebos matching the SAR components. The primary endpoint is fungal-free survival at day 90, with secondary objectives including incidence of IFD, discontinuation due to toxicity, and mortality adjusted for comorbidities.
About REZZAYO®
REZZAYO (rezafungin for injection) is a next generation echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. There are an estimated 50,000 cases of candidemia and invasive candidiasis each year in the U.S. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic BMT. CorMedix estimates that there are an approximately 130,000 patients that could constitute the addressable market for antifungal prophylaxis in the U.S. and estimates an implied total addressable market (“TAM”) of over
About CorMedix
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath® (taurolidine and heparin) for the prevention of catheter-related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products, including MINOCIN® (minocycline), REZZAYO® (rezafungin), VABOMERE® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA® (delafloxacin), and KIMYRSA® (oritavancin), as well as TOPROL-XL® (metoprolol succinate).
CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition and Pediatric patient populations and also intends to develop DefenCath as a catheter lock solution for use in other patient populations. REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of IFD in adult patients undergoing allogeneic BMT. Topline results of the Phase III study for REZZAYO are expected in Q2 2026. For more information visit: www.cormedix.com or www.melinta.com.
INDICATIONS AND USE
REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data. REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.
IMPORTANT SAFETY INFORMATION
REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins. REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion. REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation. Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy. Most common adverse reactions (incidence ≥
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange, as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix and in the Quarterly Report on Form 10-Q for the quarter ended, on June 30, 2025. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576
