PLL Therapeutics opens subsidiary in New Zealand to accelerate ALS (Amyotrophic Lateral Sclerosis) treatment and early diagnostics breakthroughs
Expansion in Asia-Pacific with second subsidiary, following Australia, pivotal to enrolling patients in phase II trial targeting ALS, a motor neuron disease with no cure
ALS patient incidence rate in New Zealand higher than global average
Villenave-d’Ornon (near Bordeaux), France, December 10, 2025 – PLL Therapeutics, a biopharmaceutical company developing a groundbreaking polypeptide delivery platform to treat the root cause of autoimmune and neurodegenerative diseases, today announces the opening of its New Zealand subsidiary, a critical move in advancing its phase II trial and addressing the urgent unmet needs of ALS patients worldwide.
The new entity will facilitate the enrollment of ALS patients in New Zealand in PLL Therapeutics’ phase II clinical trial, with the immediate goal of recruiting 12 patients at a single site, the Pacific Clinical Research Network. This initiative also paves the way for future ‘compassionate use’ programs, addressing an urgent unmet need in a country where ALS incidence and mortality rates are among the highest in the world.
New Zealand’s ALS population, though small, faces a disproportionately high burden. The incidence rate in New Zealand is higher than the global average: (NZ: ~3 in every 100,000 people, International: ~2 in every 100,000 people) with over 400 people living with the disease at any given time and approximately 120 deaths annually. The country’s universal healthcare system, renowned for its accessibility and quality, provides an ideal environment for clinical research. However, geographical isolation has historically limited patient access to cutting-edge trials.
PLL Therapeutics’ new subsidiary will bridge this gap, ensuring New Zealanders with ALS can participate in groundbreaking research and potentially benefit from innovative therapies.
“Our subsidiary in New Zealand will play a pivotal role in our R&D efforts for ALS patients in Asia-Pacific, where we also have an Australian subsidiary. It will help ensure we meet our patient enrollment targets and bring our technology to those who need it most,” said Jean-Pascal Zambaux, co-founder and CEO of PLL Therapeutics. “New Zealand’s unique position and supportive regulatory environment make it an ideal partner in our mission to bring about a fundamental shift in the standard of care in how patients living with ALS are treated and monitored in clinical follow-up, as well as prevent diseases linked to a leaky gut.”
PLL Therapeutics successfully completed its phase I trial conducted in Australia with 12 ALS patients last month, showing it was safe and well-tolerated. The phase II trial, scheduled to launch in early 2026, has received approval from the New Zealand Ethics Committee and will be conducted in partnership with local research organizations, including New Zealand Clinical Research (NZCR), a leader in ALS clinical studies.
Phase II will test the efficacy of PLL Therapeutics’ drug candidate, PLL001, based on a polypeptide delivery platform that uses poly-L-Lysine, a universal carrier, to target organs and inflammation, and restores the integrity of the gut lining (leaky gut) as well as the blood-brain-barrier.
David Tudor Phillips, newly appointed director of PLL Tx New Zealand, will oversee operations, leveraging the country’s streamlined regulatory pathways to accelerate trial implementation.
About PLL Therapeutics
PLL Therapeutics, a biopharmaceutical company, is spearheading a unique therapeutic approach for treating the root cause of autoimmune and neurodegenerative diseases based on a groundbreaking polypeptide delivery platform. In parallel, through specific biomarkers, it is advancing the early-stage diagnosis of Amyotrophic Lateral Sclerosis (ALS) a fatal motor neuron disease, and proliferative disorders (i.e. colon cancer). PLL Therapeutics focuses on restoring gut integrity. Its lead candidate is PLL001, a ‘poly-targeted’ drug therapy aimed at tackling the disease at its inception.
Founded in 2019, PLL Therapeutics is led by a highly experienced management team with decades of expertise in the CNS (Central Nervous System) and rare diseases. The company recently completed a phase I clinical trial, with a phase II underway. PLL Therapeutics is located near Bordeaux, France, and operates two subsidiaries in Asia-Pacific.
www.pll-therapeutics.com
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