Research and development

Path to market

With the involvement of some of the most reputable scientists within the respective disciplines and links to world-class research institutes in Australia and Italy, UTT BioPharma conducts a high standard of research on the cannabis plant and it’s interaction with the human body. We are making discoveries that translate to registered therapeutics, by applying for an Investigational New Drug status and subsequently conducting clinical trials.

A number of legislative and regulatory changes have been implemented at the commonwealth level, as well as at the level of all the states, for alternative supply pathways for medicinal cannabis - particularly for patients with a medical condition for which there is evidence to support its use. Regulatory change favoring immediate access to cannabis derived therapeutics will aid the UTT’s pathway to market for its proprietary candidate drugs.

Therapeutic areas

Neurodegenerative disorders

Neurodegenerative diseases are incurable and debilitating conditions that result in progressive degeneration and / or death of nerve cells. [JPND]. Damage to the nervous system results in symptoms such as ataxias and dementias.

The antioxidant potential of cannabinoids have been proven, particularly in their ability to reduce reactive oxidative species (ROS) - a key cause of damage in many neurodegenerative diseases, such as amyotrophic lateral sclerosis (ALS).

UTT-001 has the ability to decrease neurotoxicity in many neurodegenerative diseases, and potentially significantly delay the onset of the many neurodegenerative diseases.

Neuromuscular and spasticity disorders

A neuromuscular disease is a disorder that affects the peripheral nervous system. Muscle weakening and wasting leads to spasticity, twitching, cramps, aches and pains, joint and movement problems. Spasticity is a key symptom which significantly impairs quality of life and leads to further physical and mental trauma.

The endocannabinoids are known to control the tonic control of spasticity [Baker et al.], henceforth the phytocannabinoids can play an important therapeutic role. UTT is currently investigating new candidate formulations, derived from the cannabis plant, for the treatment of various neuromuscular disorders, particularly the rare conditions.

Insomnia

Insomnia is a disorder characterized by a difficulty to fall asleep or stay asleep, even if the opportunity presents itself (lying in bed awake) [Sleep foundation]. Insomnia can have a significant impact on one’s energy levels, concentration, mood and as well as the physical well-being. The prevalence of insomnia symptoms is thought to be 30%, whereas 5-10% prevalence is reported for specific insomnia disorders.

Anecdotal and preclinical data has shown that Cannabis-derived compounds have anxiolytic and somnolent properties, with minimal side effects, which are normally associated with many sleep medication.

UTT BioPharma aims to combine the somnolent compounds of Cannabis, which act in synergy, effectively to treat insomnia with minimal or no side-effects in its candidate formulation UTT-001.

An improvement of sleep will concordantly bring about significant enhancement in mood and the physical well-being of someone

  • Pre clinical
  • Phase 1
  • Phase 2
  • Phase 3
  • UTT-001
  • Amyotrophic lateral sclerosis (ALS)
  • 20%
  • UTT-001
  • Spinocerebellar ataxia
  • 20%
  • UTT-001
  • Insomnia
  • 20%
  • UTT-002
  • Excessive daytime sleepiness
  • 20%
  • UTT-003
  • Post burns pruritus
  • 20%

Cultivation

Prohibition of the cultivation of Cannabis sativa has unfortunately also restricted its breeding for medicinal purposes. A plethora of medicinal compounds are found in very low levels in the plant and are therefore very difficult to extract and purify in order to study their medical properties.

This has led to the increased proportion of ‘drug-type’ cannabis (high levels of THC) in the gene pool.

In recent years, ‘fibre-type’ cannabis (hemp) has seen a revival due to its therapeutic potential (high levels of cannabidiol, CBD).

There is still an absence of commercially available strains that produce significant levels of the other (minor) therapeutic cannabinoids.

Research goals

  • To enhance levels of therapeutic non-psychoactive compounds
  • Molecular genetic manipulation of elite cannabis clones to enhance minor cannabinoid production
  • Selection and growth optimisation of elite cannabis clones for yields of minor cannabinoids
  • Develop a pilot system of cultivation that can be scaled up for maximum yield of botanical raw material, while adhering to Good agricultural and collection practices (GACP)
  • Production of novel cannabis strains which are protected by Plant Breeder’s rights (PBR)

Large scale extraction and manufacturing

Isolation of specific cannabinoids, particularly the minor cannabinoids found in cannabis - has implications in many facets of the industry. The lower abundance of these compounds increases the difficulty of their purification.

Refining separation and isolation techniques will enable highly-purity compounds to be isolated from plant extracts.

High-purity compounds are required to improve the accuracy of research with the potential to unveil novel targets/therapies, and are necessary for development of pharmaceutical-grade products.

Research goals

  • Extraction, separation and isolation methods for the minor cannabinoids will be developed and optimised to attain high-purity compounds with low-levels of contaminants; for use in pharmaceutical applications
  • Innovative separation techniques will be developed that will be scalable, from small- to pilot- to large scale, for cannabis derivatives.
  • The resulting phytochemicals will have tremendous commercial value and are not currently available in the marketplace.