Australian-based Medlab Clinical (ASX: MDC) has reported results of a bioequivalence trial involving an orobuccal spray version of its Nanostat cardiovascular medication which have indicated improved metabolic functioning when compared to the orally-ingested tablet version.
The trial – which focused on modifying the way the drug ingredient atorvastatin is metabolised in the human body via different formulations of Nanostat – showed an improvement in “free” blood levels of atorvastatin when Nanostat is administered by 1 milligram spray rather than a 20mg tablet.
Atorvastatin is a statin (or cholesterol-lowering) medication used to prevent cardiovascular disease in high-risk patients by blocking cholesterol-producing enzymes in the liver.
The drug contains two molecules bound to a calcium salt – when this salt is cleaved off from the molecules pre-absorption, the body can metabolise free “NanoCelled” atorvastatin.
The net result is significant improvements in free atorvastatin in the blood at a lowered administered dose.
Improved “free” blood levels
Results of the bioequivalence trial indicated a two-times better blood level of free atorvastatin compared to the oral ingested 20mg atorvastatin tablet.
The results also showed peak blood concentrations of free atorvastatin could be achieved in around 30 minutes, compared to 53 minutes on the tablet.
“Our intention was to investigate the potential for a lower-dose statin delivered as an oro-buccal spray to be similar to the effects of a stronger-dose tablet,” said Medlab chief executive officer Sean Hall.
“The data has been extremely interesting – it shows a level of bioequivalence and highlights several areas of improvement which had previously not been obvious.”
Mr Hall said the company will now seek to “perfect the technique”, develop the product further and look for potential new patents for atorvastatin.
Medlab specialises in cannabis-based pain management of chronic diseases via its patented Nanocelle nano-particle delivery platform.
Last month, the company incorporated wholly-owned subsidiary MDC Europe specifically for business relating to its NanaBis cancer pain management medication and proposed drug registration models.
Mr Hall said Medlab had been in registration talks with the European Medicines Agency and confirmed that “conditional approval is likely” once a European base had been established.
“MDC is strategically placed to progress potential trade deals in Europe, especially in conjunction with the recent granting of an export licence for NanaBis,” Mr Hall said.
“This move is also very exciting as it provides NanaBis with an introduction into a large international market as a potentially future compliant drug.”
At midday, shares in Medlab were trading 8.75% higher at $0.435.