At New Zealand Clinical Research (NZCR), we pride ourselves in partnering with pioneering sponsors to jointly be at the forefront of medical innovation, consistently contributing to new and progressive advancements that improve health outcomes worldwide.
With global leaders in a range of medical specialisations, we are proud to share the positive results emerging from several key studies. Here’s a look at recent successes that underscore NZCR’s dedication to advancing global health.
Leading the Way in Hepatitis B Treatment
NZCR recently took centre stage at the 34th Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL) in Beijing. Professor Ed Gane delivered four significant presentations highlighting the developing and future landscape of liver disease treatment.
Of particular interest to attendees was the pivotal role NZCR played in the first-in-human phase of researching novel chronic hepatitis B (CHB) therapies. Professor Gane shared valuable insights into emerging combination treatment strategies, the importance of equitable access to trials across the Asia-Pacific region, and the lasting impact of finding a cure for CHB.
This underscores NZCR’s leadership in global hepatology research and our commitment to the worldwide effort to eliminate viral hepatitis by 2030. The APASL conference also reconfirmed our strong collaboration with international researchers and biotech partners, solidifying NZCR’s position as a regional leader within the global scientific community.
Pioneering Gene Editing for Hereditary Angioedema
NZCR’s research in the cutting-edge work of gene editing has garnered further international recognition with a recent publication in the prestigious New England Journal of Medicine focusing on hereditary angioedema research.
The paper details the innovative gene editing techniques, including CRISPR, base editing, and epigenetic modification that NZCR has become a leading specialist in. Our dedication to this transformative area of research is evident in our participation in over 10 gene editing studies to date, with the UNIVERSE trial serving as a prime example.
In this significant Phases 1 and 2 study, the 14 participants enrolled at NZCR formed a substantial portion of the global cohort, demonstrating our capacity to contribute meaningfully to groundbreaking international research.
Significant Progress in Cystic Fibrosis Treatment
We are thrilled to announce that RCT2100, an inhaled medication trialled in the FLAMINGO study conducted by NZCR, has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of Cystic Fibrosis (CF). Orphan Drug Designation is a regulatory status granted by government bodies, like the FDA, to drugs intended to treat rare diseases This designation marks a crucial milestone in the development of new therapies for this challenging genetic condition.
The FDA’s Orphan Drug Designation provides significant incentives for the development of treatments for rare diseases like CF, potentially accelerating the availability of new options for patients.
RCT2100, developed by ReCode Therapeutics, represents a promising new approach, utilising messenger RNA (mRNA) and lipid nanoparticles (LNPs) to target the underlying cause of CF at a cellular level, particularly benefiting those with rare mutations that are often harder to treat.
NZCR played a direct and vital role in the Phase 1 clinical trial for RCT2100 in Auckland, with the study expertly led by Mayoma Wijesundera, Rohit Katial, and Samantha Nie, supported by our dedicated team.
The successful and timely completion of every cohort underscores NZCR’s commitment to high-quality trial execution and our contribution to bringing hope to families affected by cystic fibrosis globally. [Read More]
NZCR’s unwavering commitment to running cutting-edge clinical trials is a testament to the incredible team of world class specialists at the forefront of clinical research, backed by a strong team of PIs and our comprehensive suite of in-house services, including class-leading labs and pharmacies.
Meet Our Expert Team of Clinical Research Professionals
From pioneering new treatments for liver disease and leveraging the transformative potential of gene editing to contributing to significant progress in cystic fibrosis therapy, our dedicated team in New Zealand is making a tangible difference on the world stage, bringing hope and innovative solutions to patients facing complex health challenges.
