Author: curadel

Curadel Pharma Initiates Phase 3 Trial of ZW800-1, a First-in-class Zwitterionic Drug for Optical Surgical Navigation

Posted on March 12, 2025 by - Uncategorized

Trial initiation follows completion of successful Phase 2 cohort, which met primary endpoints

BOSTON – March 12, 2025 – Curadel Pharma, a pioneer in zwitterionicity and innovator in advanced radiotherapies and drugs for optical surgical navigation, announced today that it has initiated the Phase 3 portion of its pivotal study evaluating the investigational ZW800-1 (nizaracianine triflutate) to highlight the ureter during abdominopelvic surgery.

“As the first zwitterionic near infrared (NIR) fluorophore, ZW800-1 represents an important advancement in enhanced surgical imaging. The first portion of this pivotal study found that strong visual contrast enhancement of the ureters provided apparent benefit to both patient and surgeon without compromising safety,” said John V. Frangioni, M.D., Ph.D., Curadel founder and CEO. “With confidence in our target dose, we look forward to expanding the trial to eight sites worldwide with more than 50 surgeons. Our goal is to demonstrate for the first time that surgeons can assess ureter anatomy, function, and intactness in real time during open, laparoscopic, and robotic surgeries.”

ZW800-1 is a novel small molecule drug with a unique zwitterionic chemical structure that prevents the drug from binding non-specifically to tissues and organs after injection, and facilitates its elimination by the kidneys into urine. Once in urine, the drug creates visual contrast in the ureters that would otherwise not exist, and using a near-infrared (NIR) camera, surgeons can find the ureters and assess their function in real-time.

The Phase 3 portion of the trial has been approved for enrollment based on positive Phase 2 study findings. During Phase 2, ZW800-1 met its composite primary endpoint of a strong signal-to-background ratio and visualization of the required length of ureter(s), all with a favorable safety profile. There were no severe adverse events associated with the study drug. An optimal dose of only 2.5 mg will be utilized in the Phase 3 cohort, which expects to enroll more than 300 participants worldwide. More information on the trial can be found at clinicaltrials.gov (NCT06101745).

Curadel Pharma secures $10.5M in series A2 funding to propel novel Zwitterionic Radiotherapy Platform

Posted on January 13, 2025 by - Uncategorized

BOSTON – March 2025 – Curadel Pharma, a pioneer in zwitterionicity and innovator in advanced radiotherapies and imaging drugs, announced completion of a Series A2 funding round, securing $10.5M to advance early stage development for its lead programs.

“We are building a strong body of evidence that our zwitterionic platform has broad applicability in the oncology landscape and the funding we’ve attracted from strong investment partners demonstrates the enthusiasm for this opportunity,” said John Brimacombe, Curadel President. “Building upon strong proof of concept data in imaging drugs, we are now focused on applying the power of zwitterionicity to deliver profound improvements in the outcomes associated with TATs, initially for rare cancers.”

The most recent funding aims to support critical validating steps for the platform and the lead candidate CPI-003, including proof of synthesis studies, preclinical development and regulatory preparations. Work continues on ZW800-1, Curadel’s imaging drug, which is under evaluation in a pivotal trial led by a Tier 1 medical device company.

Curadel Pharma initiates Phase 2 Portion of the Pivotal trial of ZW800-1, a first-in-class Zwitterionic Ureter imaging surgical drug

Posted on January 13, 2025 by - Uncategorized

BOSTON – July 2024 – Curadel Pharma, a pioneer in zwitterionicity and innovator in advanced radiotherapies and imaging drugs, announced the initiation of a pivotal study evaluating its investigational imaging-guided drug ZW800-1 (nizaracianine triflutate) to highlight the ureter during abdominopelvic surgery.

“A major unsolved problem in surgical imaging is anatomical enhancement of the ureters. Damage to the ureters is a serious unintended complication of abdominopelvic surgery, leading to high patient morbidity and cost. Visual contrast enhancement of the ureters can provide enormous benefit to both patient and surgeon,” said John Frangioni, MD, PhD, Curadel founder and CEO. “ZW800-1 is the world’s first zwitterionic near infrared (NIR) fluorophore, with a strong and growing body of data supporting its safety and efficacy to enhance outcomes in this critical setting.”

ZW800-1 is a novel small molecule drug with a unique zwitterionic chemical structure that prevents the drug from binding non-specifically to tissues and organs after injection and facilitates its excretion by the kidneys into urine. Once in urine, the drug creates visual contrast in the ureters that would otherwise not exist, and using a near-infrared (NIR) camera, surgeons can find the ureters and assess their function in real-time. ZW800-1 has been out-licensed to a Tier 1 medical device company.

The multi-center, multi-national TRIPHASE trial will assess ZW800-1 to aid visualization of the ureters throughout surgery, and in so doing, help lower the risk of injury and improve patient outcomes. The first phase of the trial will determine the optimal dose. Patients enrolled in the second phase will be randomly assigned to the selected dose of the drug or placebo, and those in the third phase will all receive drug at the target dose. More information on the trial can be found at clinicaltrials.gov (NCT06101745).

This trial is based on the positive results of a Phase 1/2 trial, which demonstrated its utility in visualizing and assessing ureter structure and function during laparoscopic lower abdominal surgery within 10 min after IV administration, without altering the look of the surgical field. Those study results were published in Nature Communications in 2019.