News Feature | April 16, 2014

Critical Pharma Begins Phase 1 Trial Of Nano-Enabled Osteoporosis Drug

By Estel Grace Masangkay

Critical Pharmaceuticals with collaborators The University of Nottingham and Nottingham University Hospitals NHS Trust announced the initiation of the first Phase I trial for a nano-enabled intranasal teriparatide product. The product will be evaluated for the treatment of osteoporosis in post-menopausal women.

Teriparatide is a highly effective, injectable treatment for osteoporosis. The collaboration aims to develop a nano-enabled nasal spray formulation of the drug using Critical Pharmaceuticals’ CriticalSorb technology. The new formulation will improve efficacy by providing optimal drug levels in the body. It will make administration of the drug easier for patients.

Professor Alan Perkins from The University of Nottingham’s Division of Radiological and Imaging Sciences, and 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.”

Osteoporosis affects approximately 200 million women around the world. Over 180,000 patients suffer fragility fractures every year in the UK alone, costing the NHS around £2 billion.

The clinical trial is designed as a five-way cross-over study in healthy post-menopausal women representative of the drug’s target patient population. The trial aims to examine pharmacokinetics after intranasal administration of three doses of the investigational teriparatide formulation against subcutaneous injection. The study will also assess the performance of two different nasal delivery devices.

Gareth King, CEO of Critical Pharmaceuticals, said, “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.”