RO®101 is a synthetic antimicrobial formulation with tissue regeneration properties which delivers Reactive Oxygen® for the treatment, in the first phase of development, of Chronic Non-Healing Wounds. The first pharmaceutical form of RO®101 will be a surface-activated agent, with other topical forms under development.
The development of RO®101 builds on the safety and efficacy data established from Matoke® Holdings Ltd’s pre-existing CE-marked SurgihoneyRO™.
Target Product Profile
Product: Antimicrobial surface activate agent Active Ingredient: Hydrogen Peroxide
Treatment: Chronic Non-Healing Wounds Development Stage: Pre-clinical, with open-label proof of concept trial in late 2019
In addition to RO®101’s potential as an antimicrobial and in wound healing, Matoke® Holdings Ltd’s pre-clinical programme is underway to demonstrate RO®101’s broad spectrum in vitro activity for:
- Biofilm penetration
- Tissue regeneration properties
- Immune system stimulation
- Efficacy against Gram-positive and Gram-negative bacteria
- Antifungal activity
- Antiviral activity
Chronic Non-Healing Wounds are an area of medical need due to the role of AMR and Biofilm production, as well as other number of factors that delay the ability of chronic wounds to heal, and is the initial focus for RO®101.
The size of the Chronic Non-Healing Wound market is significant. Globally, the scale of the problem is immense, with Chronic Non-Healing Wounds affecting c. 2% of the general population in the US. The problem is growing due to the burgeoning antimicrobial resistance crisis. An initial, non-validated assessment, estimates the overall size of the market at over 16 million patients in the EU and US. Of these, 1.4 million patients are associated with poor outcomes and high costs due to treatment complications and long durations of treatment. The use of systemic antibiotics and associated potential for multi-drug resistance are also of significant concern.
Standard of Care
The standard of care for Chronic Non-Healing Wounds is widely variable, due to patient and local practice variability and complexity associated with wound care. In addition, there is a lack of effective treatment options, adding to the increased costs for wound care. Thus, there is need to develop products designed to improve healing rates and prevent wound formation.
There are currently no existing therapies available or in the pipeline which can provide non-systemic, potent antimicrobial qualities against multi-drug resistant organisms, and maintain potential for biofilm penetration and tissue regeneration.