PLL Therapeutics has announced 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’ programmes, 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, with more than 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, but 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 the Asia-Pacific region, 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 organisations, 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 restore 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.