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Critical Pharmaceuticals, The University of Nottingham and NUH Starts First Phase I Clinical Trial

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Critical Pharmaceuticals, The University of Nottingham and Nottingham University Hospitals NHS Trust have announced the start of the first Phase I clinical trial in healthy post-menopausal women of a nano-enabled intranasal teriparatide product for the treatment of osteoporosis.

Osteoporosis affects an estimated 200 million women world-wide and more than 180,000 patients suffer fragility fractures in the UK alone each year, at a cost of around £2 billion to the NHS.

Teriparatide is a highly-effective treatment for osteoporosis, but it currently needs to be injected every day. The project is using Critical Pharmaceuticals CriticalSorb™ technology to develop a nano-enabled nasal spray formulation of teriparatide that is easy for patients to take and improves efficacy providing optimal drug levels in the body.

Professor Tahir Masud, Consultant in Geriatric Medicine at Nottingham University Hospitals NHS Trust and Chief Investigator for the clinical trial, said: "I look forward to progressing this exciting new therapy for a very debilitating disease into the clinic. 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 clinical trial is a five-way cross-over study design in healthy post-menopausal women representative of the target patient population. The objectives of the study are to understand the levels of the drug in the body (pharmacokinetics) after intranasal administration of three doses of the teriparatide product versus subcutaneous injection of marketed product (ClinicalTrials.gov Identifier NCT01913834).

The study will also test the performance of two different nasal delivery devices and use scintigraphic imaging to better understand how deposition can influence the levels of drug in the body over time.

Professor Alan Perkins, from The University of Nottingham’s Division of Radiological and Imaging Sciences who is leading the medical imaging aspects of the study, said: "This is an exciting study assessing a new route for the administration for teriparatide. The world-leading imaging facilities in Nottingham will be used to good effect to understand the deposition and clearance characteristics of the drug formulation in the nasal cavity. We will compare delivery from two different devices and relate the results to the levels of the drug in the body to enable an optimal drug-device combination to be selected for further development."

Dr Gareth King, CEO of Critical Pharmaceuticals commented: "We are very pleased to be involved in this collaboration with the internationally-recognized team in Nottingham. 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 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.

Dr Richard Pearson in the School of Medicine, the University Principle Investigator on the grant award, said “I am delighted that the clinical trial has now commenced and I’m keenly awaiting the data on the nasal residency and the pharmacokinetic profile regarding the novel formulation.”