TolaSure (BM-3103) / Biomendics - LARVOL DELTA

TAMES: A Phase II, Placebo Controlled, Clinical Trial of Topical TolaSure Targeting Aggregated Mutant Keratin in Epidermolysis Bullosa Simplex (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: BioMendics, LLC | Trial completion date: Sep 2026 ➔ Sep 2027 | Trial primary completion date: Dec 2025 ➔ Jan 2027

Trial completion date • Trial primary completion date • KRT14 • KRT5

BioMendics, LLC…announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BM-3103, formulated as TolaSure Gel™, for the treatment of Epidermolysis Bullosa Simplex (EBS). (Businesswire) - "BioMendics is conducting the TAMES-02 Phase 2 clinical trial (ClinicalTrials.gov NCT07027345), evaluating BM-3103 (TolaSure® Gel™) in patients with Epidermolysis Bullosa Simplex in collaboration with leading investigators at Northwestern University Feinberg School of Medicine and Stanford University School of Medicine."

Fast track • Dermatology • Genetic Disorders

Promoting autophagy as a novel therapeutic approach for the keratinopathy epidermolytic ichthyosis (SID 2026) - "This ameliorative effect was significantly better than the impact of rapamycin (p<0.0005). By targeting a shared pathogenic mechanism across keratinopathies. BM-3103 demonstrates mechanistic activity in EI keratinocytes consistent with a disease-modifying approach and warrants continued translational and clinical investigation."

Atopic Dermatitis • Dermatology • Immunology • Vitiligo

(TAMES): A Phase II, Placebo Controlled, Clinical Trial of Topical TolaSure Targeting Aggregated Mutant Keratin in Epidermolysis Bullosa Simplex (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: BioMendics, LLC

New P2 trial

Autophagy induction as a new therapeutic target for pachyonychia congenita (SID 2025) - "Induction of autophagy in PC cells increasing KIF network stability through the degradation of mutant and damaged keratins. mTOR inhibitors like BM-3103 need to be clinically tested to assess impact on blistering and ichthyosis."

Atopic Dermatitis • Dermatology • Immunology • Pain • Vitiligo • KRT16 • KRT17 • KRT6A

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