Sydney-based Pharmaxis (ASX:PXS) has announced a research collaboration with Sydney’s Woolcock Institute of Medical Research to develop a novel inhalation therapy for the treatment of cystic fibrosis (CF).
Pharmaxis, which has enjoyed a positive run of recent announcements, has an established record in the development of dry powder therapies for CF with the development and ongoing commercialisation of PBS-listed BRONCHITOL (mannitol).
The National Health and Medical Research Council (NHMRC) has awarded a research grant of $421,545 for the development and testing of the ORBITAL INHALER with a dry powder formulation of the antibiotic tobramycin.
The project will be led by Woolcock Institute Deputy Director and Head of Respiratory Technology Professor Paul Young along with Professors Daniela Traini and Scott Bell.
The inhaler is a Pharmaxis invention that has been designed to deliver high-doses of dry powder drugs to the lungs in a more effective and convenient manner than existing technology.
“This research will bring together the acknowledged expertise of the Woolcock Institute and Pharmaxis in the field of cystic fibrosis. We are pleased the NHMRC is supporting this research which we believe has potential to see Australian innovation translated into a commercial product ready for late stage clinical trials and partnering,” said Pharmaxis CEO Gary Phillips.
Professor Scott Bell, of The Prince Charles Hospital and QIMR Berghofer Medical Research Institute, said: “Australia is at the leading edge of CF treatment. We have around 3200 people with CF in Australia, and each will need to receive regular antibiotic treatment for lung infection, occurring due to the thick mucosal secretion build-up in the lung. If these are not treated effectively, progressive lung deterioration occurs. The ability to deliver antibiotics locally, using the Orbital device overcomes a number of challenges that we are facing in the clinic, and this clinical trial is likely to pave the way to better health outcomes and quality of life.”
According to Professor Paul Young, Woolcock Institute Deputy Director and Head of Respiratory Technology, “While antibiotic treatment options for patients with cystic fibrosis has come a long way, the use of innovative devices such as the Orbital will be a significant step forward. Currently, CF patients have to grapple with loading multiple drug-containing capsules into their devices when taking their daily dose of antibiotics. With a lack of flexibility in this model, patients may encounter tolerability and cough issues along with logistical issues relating to loading, emptying and cleaning of their inhaler. The Orbital circumvents these problems by providing a press-button, single use device containing the whole antibiotic dose that the patient can inhale over a number of breaths that are suitable to them. This approach would not only improve the quality of life for CF sufferers but mark a revolutionary way in which we deliver antibiotics for CF.”
The ORBITAL INHALER is capable of delivering a high payload of antibiotics for the treatment of infection in cystic fibrosis patients.
"Currently treatments for cystic fibrosis infection are via oral, intravenous or lengthy inhalation processes. This can lead to significant side effects, consequent poor patient compliance, and limited therapeutic efficacy," said the company.
A Phase 1 clinical trial conducted by Pharmaxis has shown the inhaler can administer large amounts of dry powder to healthy subjects in one inhalation without compromising safety or tolerability. The compact device is capable of housing up to 400mg of powder for inhalation within a specially designed dosing chamber and delivers sequential doses to the patient with a simple one touch deployment.