First cohort successfully dosed in EBC-1013 Phase I wound healing clinical trial
BRISBANE, 5 August 2025
QBiotics Group Limited (QBiotics) has successfully dosed the first cohort of participants (cohort 1) in its EBC-1013 first in human, Phase I wound healing safety trial (QB1013C-H201). The trial will now advance to the next dose concentration in accordance with the study protocol.
EBC-1013 is a topically applied, semi-synthetic small molecule, that has the potential for the treatment of a wide range of chronic and acute wounds and burns. It modulates multiple pathways, affecting different stages of the wound healing process.
The placebo-controlled, Phase I dose escalation trial is designed to assess the safety and tolerability of EBC-1013 in patients with Venous Leg Ulcers (VLUs). It is open at four sites in Australia and aims to recruit adult participants, in up to five ascending dose concentration cohorts.
“We are encouraged by the safe dosing of the initial patient cohort in our EBC-1013 Phase I clinical trial, marking the beginning of what we anticipate will be a meaningful contribution to the treatment of venous leg ulcers,” said QBiotics CEO and Managing Director, Stephen Doyle. “These wounds are painful, slow to heal, and represent a significant global unmet medical need - often referred to as a ‘silent epidemic’. With little innovation in venous leg ulcer treatments over the past 20 years, and with the global VLU market projected to exceed US$5.8 billion by 2031, the opportunity to make a real difference is substantial.”
VLUs are painful, deep open sores caused by poor circulation and damaged veins with a global prevalence estimated at 0.32% of the population2. The market for Venous Leg Ulcers is rapidly growing, being driven by ageing population and the increasing incidence of diabetes and obesity1. These wounds represent a significant unmet need as 20% of VLUs do not heal despite receiving current ongoing standard of care treatment2.
With the Safety Review and Dose Escalation Committee confirming that the trial can proceed to the next dose concentration cohort, recruitment is underway to identify participants to assess the next dose level in cohort 2.
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ABOUT TRIAL QB1013C-H201
QB1013C-H201 (ACTRN12624000544572) is a Phase I, first-in-human, placebo-controlled, dose escalation study assessing the safety and tolerability of EBC-1013 in up to 33 participants with venous leg ulcers (VLUs). The study is being conducted at 4 sites across Australia.
The trial is 3+3 dose escalation design, investigating different dose levels of EBC-1013 gel, compared to a placebo-control.
The Primary Endpoint of the study is the incidence of adverse events (AEs) and serious adverse events (SAEs) over a 28-day study period. Secondary Endpoints include assessment of systemic pharmacokinetic parameters and Dose limiting local toxicity. Exploratory Endpoints include initial efficacy assessments of wound healing and quality of life.
- https://growthmarketreports.com/report/venous-leg-ulcer-vlu-treatment-market-global-industry-analysis
- Probst et al., 2023. Prevalence and incidence of venous leg ulcers—A systematic review and meta-analysis. Int Wound J. 2023;20:3906–3921. DOI: 10.1111/iwj.14272
FURTHER INFORMATION - STEPHEN DOYLE, CEO & MANAGING DIRECTOR
or
MEDIA ENQUIRIES - JANE LOWE, IR DEPARTMENT
jane.lowe@irdepartment.com.au or +61 411 117 774
NOTES FOR EDITORS
ABOUT QBIOTICS
QBiotics is an unlisted, public Australian life sciences company that seamlessly connects scientific discovery, development and commercialisation to harness the power of nature to treat diseases of high unmet need.
Our current clinical focus is on novel treatments for cancer and debilitating chronic wounds. We also have an early-stage antibiotics program.
QBiotics’ lead molecule, tigilanol tiglate, is a novel, small molecule with the potential to treat a broad range of solid tumours. It is currently in Phase II clinical trials in two indications: soft tissue sarcoma (STS) and head and neck cancer (HNC). Tigilanol tiglate was granted Orphan Drug Designation by the US FDA for the treatment of STS in February 2024.
A veterinary formulation of tigilanol tiglate (STELFONTA®) is approved for the treatment of canine mast cell tumours, in major global markets, including the USA, Europe, and Australia. QBiotics has partnered with Virbac, a global animal health company, to distribute STELFONTA®.
Our wound healing drug candidate, EBC-1013, is a small molecule, which targets multiple pathways to accelerate healing, improving outcomes in chronic and acute wounds and burns. A first-in-human Phase I clinical trial in venous leg ulcers is actively recruiting.
For more, head to: qbiotics.com or LinkedIn