BioMendics Receives FDA Fast Track Designation for BM-3103 (TolaSure® Gel™) for Epidermolysis Bullosa Simplex
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BioMendics' rare dermatologic candidate BM-3103 (TolaSure® Gel™) has secured an expedited regulatory path via FDA Fast Track Designation for epidermolysis bullosa simplex, supplementing its active Orphan Drug and Rare Pediatric Disease statuses.
Lead candidate BM-3103 (TolaSure® Gel™) now holds Fast Track, Orphan Drug, and Rare Pediatric Disease designations as BioMendics advances the TAMES-02 Phase 2 study (NCT07027345). BioMendics, LLC, a clinical-stage biotechnology company developing innovative therapies for rare genetic skin disorders, today 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). The milestone comes as the company prepares to attend the BIO International Convention 2026 in San Diego (June 22–25).
Combined with our Orphan Drug and Rare Pediatric Disease designations, Fast Track positions BM-3103 for an accelerated development path. The designation follows FDA review of the company's Fast Track request. In its notification to BioMendics, the Agency stated: “We have reviewed your request and concluded that it meets the criteria for the Fast Track designation. Therefore, we are designating this product as a Fast Track product for epidermolysis bullosa simplex (EBS).”
Fast Track Designation is intended to facilitate development and expedite review of therapies that address serious conditions and unmet medical needs. Benefits include more frequent FDA interactions, enhanced opportunities for regulatory guidance, eligibility for Rolling Review, and potential qualification for Priority Review.
“This designation is a significant milestone for BioMendics and, more importantly, for the individuals and families living with Epidermolysis Bullosa Simplex,” said Karen McGuire, PhD, Chief Executive Officer of BioMendics. “Combined with our Orphan Drug and Rare Pediatric Disease designations, Fast Track positions BM-3103 for an accelerated development path. We look forward to sharing this progress at BIO 2026 as we continue to advance BM-3103 for patients with rare genetic skin disorders.”
Advancing the TAMES-02 Phase 2 Clinical Trial
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.
“For individuals living with EBS, even modest improvements in blister burden, pain, itch and quality of life can be meaningful,” added Amy S. Paller, MD, MS. “The TAMES-02 study represents an important opportunity to further evaluate a potential therapeutic option for this patient population. We are encouraged by the continued progress of the program and its recognition by the FDA through Fast Track Designation.”
"Families affected by EBS face daily challenges that can profoundly impact quality of life," said Brett Kopelan, Executive Director of DEBRA of America. "The FDA's Fast Track Designation for BM-3103 highlights the importance of advancing promising investigational therapies and underscores the urgent need for innovation in rare genetic disorders that manifest in the skin."
BioMendics has also partnered with Sano Genetics to support patient engagement and recruitment for the TAMES-02 study through its Virtual Waiting Room platform. The platform enables patients and caregivers to learn about the study, assess potential eligibility, and stay informed about program progress and future participation opportunities.
About BioMendics
BioMendics is a clinical-stage biotechnology company focused on developing innovative therapies for rare genetic skin disorders. Its lead product candidate, BM-3103 formulated as TolaSure® Gel™, is being developed for Epidermolysis Bullosa Simplex and other rare dermatologic conditions.
