Research & Development

Clinical Development

LGP believes that its brand recognition and reputation as a medicinal cannabis provider will likely be derived from its commitment to clinical development activities aimed at developing innovative products, including novel delivery systems and precisely formulated cannabinoid products, as well as improving the methods, processes and technologies employed to manufacture such products on a commercial scale.

Below are brief descriptions of the Company’s current clinical development programme activities:

Patented small Particle Formulation

Little Green Pharma’s research has indicated that its small particle formulation product may offer two primary advantages:

(i) the manufacturing method uses high-pressure, cool-temperature homogenisation, which is anticipated to better preserve the natural profile of cannabinoids and terpenes present in the plant material. Alternative homogenisation methods, such as ultrasonication are known to decarboxylate many cannabinoids and alter the natural profile of cannabinoids and terpenes in the plant material; and

(ii) the use of a small particle emulsion is anticipated to result in more rapid absorption, higher bioavailability, prolonged therapeutic effects, lower toxicity, and improved ease of administration and dosage control than simple oil products.

A 2018 independent scientific review by the University of Otago suggested that a small particle formulation product may represent a significant improvement over currently available cannabis oil delivery systems and could enable a three to six-fold reduction in the cannabinoid dosage required to achieve an equivalent therapeutic effect compared to LGP’s existing medicinal cannabis oil products.

Reducing the dosage may help alleviate many of the dose-dependent adverse effects and reduce the cost-per-dosage administered.

Should product development be successful, it is planned that the liposomal small particle technology and patented formulation would then undergo additional trials as may be required to progress to a SAS-B pathway prescription drug.

ARISE

Little Green Pharma is progressing a novel product development and formulation project with Curtin University in Western Australia. Curtin University owns a patented atomised rapid injection for solvent extraction (ARISE) technology that generates particles of active pharmaceutical ingredients that are more readily absorbed by the body. The Company, together with its Scientific Advisor and inventor of the ARISE technology, Professor Neil Foster, is finalising a research and development agreement with Curtin University pursuant to which the parties will seek to explore new formulations that utilise the ARISE technology, including buccal drug delivery systems and fast-dissolving oral formulations capable of delivering micro-dose cannabinoid therapy.

Meanwhile, the Company and Curtin University have also entered into a licence agreement for the exclusive use of the ARISE patented technology in connection with cannabis as well as any new intellectual property generated by this research and development agreement.

Other opportunities

LGP is also continuing to negotiate a fully-termed agreement in connection with its non-binding term sheet with OBJ Limited (ASX:OBJ) for the development of cannabis-related products utilising OBJ Limited’s diamagnetic microarray transdermal technology. The proposed

project would be supported by product development services provided by Curtin University.

Clinical Investigations

In addition to the above opportunities, LGP is involved in several clinical investigations, including two open-label designed studies as well as a double-blind placebo-controlled clinical trial run by a leading Australian research organisation for palliative care and advanced cancer.

These study and trial outcomes will assist in informing the Company’s future clinical trial plans and product development.