UK-based biotechnology firm Critical Pharmaceuticals has announced the start of the first Phase I clinical trial of a nano-enabled intranasal teriparatide product in healthy post-menopausal women for the treatment of osteoporosis.
Supported by the University of Nottingham, the trial is being carried out at Nottingham University Hospitals NHS Trust.
The new nasal spray will provide patients an easier method of taking the drug teriparatide, which is a highly effective treatment for osteoporosis but which needs to be injected every day.
The nano-enabled nasal spray uses Critical’s CriticalSorb technology to deliver teriparatide in a way that is not only easy for patients to take but also makes it more effective by providing optimal drug levels in the body.
About 200 million women across the world are affected by osteoporosis and over 180,000 patients suffer fragility fractures in the UK alone each year, at a cost of around £2bn to the NHS.
The five-way cross-over trial is aimed at understanding the levels of the drug in the body (pharmacokinetics) after intranasal administration of three doses of the teriparatide product compared to subcutaneous injection of the current drug treatment.
Nottingham University Hospitals NHS Trust consultant in Geriatric Medicine and chief investigator for the clinical trial professor Tahir Masud said: "A nasal teriparatide product has the potential to significantly benefit patients, their families, carers and clinicians with improved clinical outcomes and greatly enhanced ease-of-use."
The trial will also test the performance of two different nasal delivery devices and use scintigraphic imaging to better understand how the method of delivery can influence the levels of drug in the body over time.
Critical CEO Gareth King said: "We have developed a stable liquid formulation of teriparatide using Critical Pharmaceuticals’ patented CriticalSorb technology that has performed exceptionally well in preclinical studies."
"We look forward to understanding how this product performs in this first human clinical trial."
The development project is co-funded by the UK’s innovation agency, the Technology Strategy Board, Critical Pharmaceuticals and the Engineering and Physical Sciences Research Council (EPSRC) as part of their investment in nanoscale technology-enabled solutions in healthcare.
Image: Osteoporosis is an age-related disorder that causes the gradual loss of bone density and strength. Photo: courtesy of CFCF.