QBiotics leverages extensive preclinical and clinical knowledge gained from our oncology program, to develop EBC-1013, a novel semi-synthetic molecule that has excellent wound healing properties.
EBC-1013 is formulated in a gel and applied topically.
Veterinary clinical studies in horses, dogs and calves in a range of ‘real world’ chronic and acute wounds and burns has shown that EBC-1013 addresses all three wound healing needs. This includes reduced microbial load, rapid wound closure and re-epithelialisation, and excellent cosmetic outcomes with little or no scarring.
Therefore, EBC-1013 offers a significant opportunity to develop a range of advanced wound care products with potential to treat the spectrum of wound types.
EBC-1013 is in the preclinical stage of development. Formal toxicology testing is underway and cGMP production of the active pharmaceutical ingredient and the drug product is in progress.
QBiotics’ lead indication is venous leg ulcers, a significant unmet medical need, and plan to develop EBC-1013 as a pharmaceutical, which offers the potential for higher returns than other products that are registered as medical devices.
Chronic wounds, such as venous leg ulcers are a significant health problem driven by an aging population and a rising incidence of diabetes and obesity. Venous leg ulcers affect up to 1% of the adult population, rising to 3% in people over 65 years of age. The global estimated annual prevalence is 3 million. Venous leg ulcers have a poor long-term prognosis, with twelve-week healing rates of 44%, one-year healing rates of around 50% and recurrence rates up to 75 percent.
Venous leg ulcers remain a clinical challenge. Current care is focussed on compression, wound dressing and debridement that leads to variable results, with slow healing, complications and recurrence. There are no pharmaceutical drugs available to treat venous leg ulcers. Therefore, with no specific and effective solution available, there is significant potential for EBC-1013 to qualify for FDA Breakthrough status allowing approval for market at Phase IIB if sufficient efficacy is achieved.
Mode of action
EBC-1013 has a unique mode of action. It amplifies an acute inflammatory response that leads to an antimicrobial effect, disruption of bacterial biofilms, debridement of wounds that resets them to an acute mode, stimulation of reepithelialisation, and acceleration of wound closure with minimal scarring.
EBC-1013 exerts dramatic stimulatory effects on keratinocyte wound healing responses, facilitated via Protein Kinase C (PKC) activation and the downstream manipulation of gene expression profiles in favour of enhanced proliferation and migration. In the case of chronic wounds, EBC-1013 acts by first disrupting the persistent biofilm on wound surfaces, a characteristic of chronic wounds which interferes with healing. The drug then re-activates the ‘acute’ wound healing processes, activating resident immune cells in the underlying wound area, initiating the production of hypochlorous acid, removal of aberrant wound tissue, and the stimulation of re-epithelization of the dermal tissue (Moses 2020).
Composition of matter and use patents have been granted or are under examination in all major jurisdictions.
As with human development, there is the potential for EBC-1013 to treat the spectrum of wound types for companion animals. Clinical development is focused on acute wounds in horses and chronic wounds in dogs.
For burns, QBiotics is currently undertaking clinical proof of concept trials in calves and early results are promising and support the further development of EBC-1013 for both humans and companion animals.
Acute and chronic wounds in horses is the initial focus for the veterinary market due to the high incidence of injury and accidents in this species, as well as the large number of horses in the racing and leisure industries.
Wound management represents a challenge for Veterinarians, with limited options available and practical complications associated with nursing wounds back to healthy tissue in large animals that may be more remotely located.
The size of the equine wound market is difficult to estimate. However, there are currently 9.2 million horses in the USA that are used for recreational, racing and work (such as police horses) each with an average of 5 wound events per annum.