(CR-034) First Clinical Evaluation of the Safety and Efficacy of Tarumase for the Debridement of Venous Leg Ulcers

Kinga Szepeshazi, MD – Chief Clinical and Medical Affairs, Clinical and Medical Affairs, SolasCure Ltd; David Fairlamb, BSc, PGC – Regulatory Director, Regulatory Affairs, SolasCure Ltd; david Goldsmith, MD; Peter Danos, MD; Jason Hanft, DPM; Nathan Young, DPM; Charles Zelen, DPM

Introduction:

Assess the safety and tolerability of multiple ascending doses of tarumase when administered topically to participants with Venous Leg Ulcers (VLU). Assess the rate and extent of wound debridement in VLU patients.

Methods: Multicenter, open label, phase 2a multiple ascending dose clinical trial performed in 8 clinical centers across the US, UK and Hungary. Patients with VLUs of 2-50 cm² present for ≥30 days were enrolled into five Cohorts to receive tarumase 3x weekly: vehicle alone (0U/mL) in Cohort 1 (n=5), 1U/mL in Cohort 2 (n=8), 2U/mL in Cohort 3 (n=10), 5U/mL in Cohort 4 (n=9), and 9U/mL in Cohort 5 (n=10) for 4 weeks.

Results: 42 eligible patients with VLUs (mean [SD] ulcer area, 13.85 [12.7] cm²) were enrolled. The level of pain reported on a 0-10 scale had a mean [SD] improvement of -0.98 [1.81] throughout study duration. Clinical tolerability was assessed by rating the levels of bleeding (absent, present), erythema, exudate, oedema, induration (none, mild, moderate, marked) at each visit.  No worsening in clinical tolerability parameters could be observed. No treatment-related serious adverse events happened, and a total of 41 (mild to moderate severity) treatment-emergent adverse events occurred, out of which 33 were considered unrelated to study drug. Tarumase in the blood remained below quantifiable levels for all timepoints, no evidence of antibody generation and no effects on coagulation parameters (APTT/PT/Fibrinogen) were visible. Dose related improvements in wound debridement were observed, and trends towards faster rates of healing were noted based on increased granulation tissue, linear healing and reduction in surface area.

Discussion: The tarumase enzyme was well tolerated and does not cause pain, irritation or discomfort to VLU patients. A trend of dose related debridement (Figure 1) with signs of accelerated wound healing (Figure 2) could be observed. The excellent safety results promote the use of higher doses of tarumase, and the promising efficacy signals suggest that tarumase may be a game changer in wound debridement and the acceleration of wound healing.