QBiotics EBC-1013 wound healing trial advances to fourth cohort
BRISBANE, 30 July 2026
QBiotics Group Limited (QBiotics) is pleased to announce that the third cohort (Cohort 3) in its first-in-human Phase I wound healing clinical trial of EBC-1013 (QB1013C-H201) has successfully completed dosing and, following review by the trial’s Safety Review and Dose Escalation Committee, has progressed to the fourth of five possible dose-level cohorts.
The Committee identified no dose-limiting toxicities or other safety signals to date and endorsed progression in accordance with the study protocol.
EBC-1013 is a topically applied, novel small molecule with the potential to treat a broad range of chronic and acute wounds and burns. The current placebo-controlled, Phase I dose-escalation study is evaluating the safety, tolerability and therapeutic window of EBC-1013 in participants with Venous Leg Ulcers (VLUs) at four Australian clinical sites.
VLUs and other chronic wounds remain a significant burden for patients and healthcare systems worldwide, particularly when wounds fail to heal. Approximately 20% of VLUs fail to heal despite ongoing current standard-of-care treatment, highlighting the need for new therapeutic options1.
QBiotics Interim CEO and Managing Director, Ebru Davidson, said:
"Advancing to the fourth cohort without dose-limiting toxicities or other safety concerns continues to build confidence in the safety profile of EBC-1013 and supports its development as a potential new treatment option for patients with difficult-to-heal wounds."
"Venous leg ulcers and other chronic wounds remain a significant burden for patients and healthcare systems globally, with limited treatment options available for wounds that fail to heal with standard care. We look forward to completing the next stage of the trial and continuing to evaluate the potential of EBC-1013."
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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 participants with venous leg ulcers (VLUs). The study is being conducted at four sites across Australia.
The trial uses a 3+3 dose escalation design to evaluate ascending dose levels of EBC-1013 gel compared with 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 assessments of wound healing and quality of life.
- 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
EBRU DAVIDSON, INTERIM CEO & MANAGING DIRECTOR
communications@qbiotics.com
or
MEDIA ENQUIRIES
JANE LOWE, IR DEPARTMENT
jane.lowe@irdepartment.com.au or +61 411 117 774
NOTES FOR EDITORS
ABOUT QBIOTICS
QBiotics Group Limited (QBiotics) is an Australian public unlisted biotechnology company, advancing two clinical-stage, differentiated, small molecule programmes derived from our epoxytigliane platform.
QBiotics’ lead intratumoural oncology asset, tigilanol tiglate, is demonstrating strong efficacy and safety in human clinical Phase II studies. In a Phase II soft tissue sarcoma study the drug delivered an injected tumour Objective Response Rate (ORR) of 80%, with no serious Adverse Events, and translational research validating immunological responses. A Phase II study in head & neck cancer is soon to be reported and compelling safety and efficacy outcomes have been achieved in a range of other tumour types under Compassionate Use. No Maximum Tolerated Dose (MTD) was declared in a Phase I/IIa safety study and efficacy reported for nine different tumour types. QBiotics is soon to implement a Phase II trial in breast cancer in partnership with the Unicancer, the French Federation of cancer centres and is currently exploring the treatment of visceral tumours by tigilanol tiglate in a preclinical study.
QBiotics’ second programme is a topically applied regenerative wound therapy EBC-1013 that accelerates wound infill and closure, minimises scarring, and provides local antimicrobial activity. This drug candidate has demonstrated impressive safety and efficacy against chronic and acute wounds and burns in veterinary studies. It is currently in a human clinical Phase I/IIa study treating Venous Leg Ulcers.
Patent coverage for tigilanol tiglate and EBC-1013 is broad and Chemistry, Manufacturing and Controls (CMC) is mature, with commercial supply of the drug secured for both programmes.
QBiotics employs a capital-efficient model that integrates its EcoLogic™ discovery technology with phenotypic screening and early validation in veterinary disease models. This approach enables rapid identification of biologically active molecules, early demonstration of efficacy and safety in complex disease settings in the veterinary environment, and meaningful de-risking prior to human clinical development. Product development is led by an experienced team and complemented by internationally recognised Key Opinion Leaders on our Clinical and Scientific Advisory Boards, who bring deep expertise in oncology, wound healing, antimicrobials, small molecule chemistry and translational drug development.
QBiotics’ business strategy is to advance therapeutic programmes with the potential to address multiple high-value indications through to Phase II proof-of-concept in human clinical studies, and then pursue strategic partnering to accelerate late-stage development and commercialisation.
For more, head to: QBiotics.com or LinkedIn