TolaSure (BM-3103) / Biomendics - LARVOL DELTA

TAMES: Safety and Efficacy of Topical TolaSure Targeting Aggregated Mutant Keratin in Severe Epidermolysis Bullosa Simplex (clinicaltrials.gov) - P1/2 | N=6 | Completed | Sponsor: BioMendics, LLC | Recruiting ➔ Completed

Trial completion • KRT14 • KRT5

Interim results of a phase I/II, closed label, randomized pilot study for the safety and efficacy of TolaSure gel, 5% w/w targeting aggregated mutant keratin in severe epidermolysis bullosa simplex (TAMES) (ISID 2023) - "These findings support improvement of keratinocyte organization and adhesion as well as a reduction of keratin aggregates in areas of active blistering that were treated with TolaSure, suggesting potential benefit for epidermal strength and resiliency in severe EBS. These interim biomarker results provide further mechanistic insights into the clinical effect of BM-3103 and will aid in the interpretation of the upcoming safety and efficacy endpoint results for the soon to be concluded Phase I/II trial."

Clinical • P1/2 data • Inflammation • KRT14 • KRT5

TAMES: Safety and Efficacy of Topical TolaSure Targeting Aggregated Mutant Keratin in Severe Epidermolysis Bullosa Simplex (clinicaltrials.gov) - P1/2 | N=5 | Recruiting | Sponsor: BioMendics, LLC | Not yet recruiting ➔ Recruiting | Trial completion date: Nov 2022 ➔ Apr 2023 | Initiation date: Nov 2021 ➔ Apr 2022 | Trial primary completion date: Nov 2022 ➔ Apr 2023

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • KRT14 • KRT5